Programas familiares y para cuidadores de control del hábito de fumar para reducir la exposición de niños a humo de tabaco en el medio ambiente
Referencias
References to studies included in this review
References to studies excluded from this review
References to ongoing studies
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | Country: Hong Kong, China | |
| Participants | 952 parents from a birth cohort who were listed as smokers in the '1997 Birth Cohort Study' of the Department of Community Medicine, University of Hong Kong | |
| Interventions | Intervention: 20 to 30 minutes of telephone counselling with information based on individual needs; no NRT information given unless asked, and even then, information given was kept minimal. Stage‐based printed self‐help materials (based on baseline) provided just once. | |
| Outcomes | At 6 months: | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 837/952 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised; method not described |
| Allocation concealment (selection bias) | Low risk | Numbered sealed opaque envelopes |
| Incomplete outcome data (attrition bias) | Low risk | Losses to follow‐up 11% intervention/4% control. Included as continuing smokers |
| Blinding of outcome assessment (detection bias) | Low risk | "Independent interviewer...was unaware of subjects' group allocation... All respondents who reported they were not smoking during the preceding 7 days were invited to attend the research centre for biochemical validation." |
| Methods | Country: Shanghai, China Setting: community (households) Type: RCT | |
| Participants | 318 households with smoking parents or caregivers who had children aged 5 years or younger at home | |
| Interventions | Intervention: • Counselling, conceptualised on the basis of the protection motivation theory developed by Rogers 1975 • Smoking hygiene intervention (SHI) with brief advice to quit SHI: • Keeping child away from household members' and other people's smoke • Avoiding smoking in the car or in closed areas near the child • Not taking the child into smoky environments • Enforcing a strict no‐smoking policy at home and in the car Control: • Placebo intervention included counselling on child development issues • No SHI or second‐hand smoke (SHS) exposure reduction or quit smoking counselling provided by the study counsellor. When queries on smoking or SHS were raised by participants, they were given the hotline number of the Shanghai CDC's smoking cessation clinic. | |
| Outcomes | Child exposure: Primary outcomes at 6 months: • Participant‐reported improvement in smoking hygiene in the household (smoking restriction by household members at home) • Reduced exposure of child to SHS inside the home measured by mean number of cigarettes per week • Reduction in children's urine cotinine concentrations Secondary outcomes: • Total SHS exposure to child from all smokers inside and outside the home • Household members smoking cigarettes around the child • Smoking behaviour of household members (reducing the mean number of cigarettes smoked daily, making a quit smoking attempt for at least 24 hours, and quitting smoking) Child illness: Respiratory illness incidence among children as reported by key household members Target behaviour change: Secondary outcome at 6 months: • Smoking behaviour of household members (reducing mean number of cigarettes smoked daily, making a quit smoking attempt for at least 24 hours, and quitting smoking). Verified by CO measure | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: Flight Attendant Medical Research Institute (FAMRI), USA, grant 072233_CIA; and American Academy of Pediatrics, Julius B. Richmond Center of Excellence | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers were computer‐generated by the project manager (not counsellors) before participant recruitment. |
| Allocation concealment (selection bias) | Low risk | Counsellor opened a serially numbered, opaque, and sealed envelope to reveal the random assignment of each smoker to intervention or control group. |
| Incomplete outcome data (attrition bias) | High risk | Large dropout rate; more than 40% of the households in each group were not available. This was the result of many households relocating to a new residential area, farther from the original study area. Analysis does not appear to be intention‐to‐treat. |
| Blinding of outcome assessment (detection bias) | Low risk | Not blinded but objective measure (cotinine) |
| Other bias | High risk | In addition to dropout rate: • Small possibility of cross‐contamination between intervention and comparison groups • Dosing (i.e. contact duration and frequency) of the intervention was not equal for the intervention and comparison groups • Social desirability bias due to interview format |
| Methods | Country: Australia | |
| Participants | 181 women recruited from a postnatal ward who had given birth to a single live infant, identified as 'at risk' (1 or more of identified physical domestic violence, identified childhood abuse by either parent, sole parenthood, or ambivalence to pregnancy; as well as 3 or more of maternal age < 18 years, unstable housing, financial stress, poor maternal education, low family income, social isolation, history of mental health disorder, drug or alcohol abuse, and domestic violence other than physical abuse) | |
| Interventions | Intervention: • Home‐based intervention focused on establishing trust with families, enhancing parenting self‐esteem and confidence, providing guidance for child development including crying and sleep behaviour, promoting preventive child health care and facilitating access to child health centres • Weekly home nurse visits for first 6 weeks, fortnightly for 3 months, then monthly until 6 months postpartum • Usual care | |
| Outcomes | At 4 months: • Health outcomes only reported at 12 months | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A random number table was computer generated." |
| Allocation concealment (selection bias) | Low risk | The random number table was "used by a clerical officer not involved in determining eligibility to determine intervention status". |
| Incomplete outcome data (attrition bias) | Low risk | Similar rates of retention at 12 months in both arms (76% intervention, 77% control) |
| Blinding of outcome assessment (detection bias) | Low risk | "Data were collected in the home by a researcher who was naive to the intervention status of the participants and was not involved in providing healthcare to the participants." |
| Methods | Country: Iran Setting: recruited from health centres, intervention face‐to‐face/on phone RCT | |
| Participants | 130 families with healthy infants younger than 12 months | |
| Interventions | Intervention: • Counselling (motivational interviewing) of mothers and fathers Control: • Usual care (health visits for checking infant's growth and developmental milestones) • Parents given a pamphlet and sticker depicting a smoke‐free home | |
| Outcomes | Infant urinary cotinine at baseline and at 3 months Change in parental smoking Home and car smoking bans | |
| Type of intervention | Well‐child (child health check) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | Low risk | 4/65 lost to follow up in control group and 5/65 in intervention group |
| Blinding of outcome assessment (detection bias) | Low risk | The statistical analyst and outcome assessors were blinded to the group assignment, the control group was uninformed of the counselling processes. |
| Methods | Country: USA Setting: community (home) Type: RCT | |
| Participants | 165 caregivers and their infants born at ≤ 32 weeks' gestational age, within 6 weeks of discharge from the NICU | |
| Interventions | Intervention: • Counselling provided by 1 of 2 research nurses trained in motivational interviewing and actively supervised by an expert in the field • Sessions included smoking cessation or relapse prevention counselling for willing caregivers who were current or former smokers, while second‐hand smoke exposure control efforts were explored and reinforced for all • Motivational interviewing technique used: elicit‐provide‐elicit • Trialists also offered information on resources (e.g. smokers quit line, pharmacotherapy) Control: • Brief asthma education at baseline only | |
| Outcomes | Child exposure: • Postintervention infant exposure to second‐hand smoke assessed via caregiver‐reported data from survey that occurred closest to completion of the intervention (5‐month survey) • Salivary cotinine samples obtained at study end (8 months after NICU discharge) used as an objective measure of infant SHS exposure Child illness: • Respiratory symptoms assessed by asking caregivers to quantify in the past 2 weeks number of days with wheeze/cough, number of nights awakened because of wheeze/cough, number of days having taken rescue medication, and number of symptom‐free days Child health service utilisation: • Asked caregiver about numbers of visits to primary care provider and emergency department, and hospitalisations for wheezing or breathing problems since the prior survey Target behaviour change: • Smoking ban in home/car, caregiver confidence, and motivation to quit smoking | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: grant from the Halcyon Hill Foundation (Halterman, PI), which had no involvement in submission of this manuscript for publication | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not specified |
| Allocation concealment (selection bias) | Low risk | Concealed envelope system, stratified by caregiver‐reported routine infant SHS exposure |
| Incomplete outcome data (attrition bias) | Low risk | 12.7% of participants dropped out (18.1% in the treatment group vs 7.3% in comparison group) |
| Blinding of outcome assessment (detection bias) | Low risk | Assessments were completed by study team members blinded to the infants' randomisation category. Objective measure also used (cotinine) |
| Methods | Country: USA Setting: recruited from various sites including hospital in‐patient settings and clinics, Latino cultural events. Intervention involved counselling visits and phone calls. Type: RCT | |
| Participants | Latino caregivers who smoked and had a child with asthma | |
| Interventions | Group 1: Behavioral action model (BAM). This was modelled on clinical guidelines for smoking cessation. The model focused on increasing the smoker’s self‐efficacy to quit by teaching problem solving and coping skills. Group 2: Precaution adoption model (PAM). This model used feedback on the caregiver’s carbon monoxide level and the child’s second‐hand smoke exposure, using motivational interviewing techniques. Eight weeks of transdermal nicotine patches were available free of charge if participants were ready to quit. | |
| Outcomes | Passive nicotine monitors at baseline and at 3 months after completion of treatment Level of functional morbidity due to asthma Smoking cessation by caregiver; self‐report and expired air CO concentration (continuous abstinence, 7‐day point prevalence abstinence) | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Attrition 37/133 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised by computer‐generated sequence |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | High risk | Attrition 37/133 |
| Blinding of outcome assessment (detection bias) | Low risk | Self‐report assessments administered by research assistants blinded to the treatment condition |
| Other bias | High risk | Selection bias. Some participants were enrolled from other studies, so it may be difficult to elicit study‐specific effects. Inconsistencies in presentation of data: BAM group (n = 68) had results for n = 49 at the end of the study, and not all were accounted for. Similarly in the PAM group, n = 65 and completed n = 49 at end of treatment, and not all were accounted for. Outcomes presented for 'acculturation' and 'asthma morbidity', but no details on how these were assessed. |
| Methods | Country: USA Setting: community (home and telephone) Type: RCT | |
| Participants | 560 smoking primary caregivers (parents) of both children with asthma and healthy children | |
| Interventions | • Precaution adoption model intervention (PAM; motivational interviewing to deliver feedback on child's second‐hand smoke (SHS) exposure and smokers' carbon monoxide levels and cessation induction strategies). • Home visit (for aim 1/teachable moment): Parents of children with asthma received NIH guideline‐based asthma education, while parents of healthy children received child wellness counselling. All participants received identical smoking cessation counselling via motivational interviewing. Verbal and graphical feedback was provided regarding smoking level, carbon monoxide level, how quitting could reduce disease risk and symptoms, the child's SHS exposure, risk of smoking on the child's SHS exposure, and how risks could be reduced by quitting smoking or reducing SHS exposure. • Telephone counselling (for aim 2/intervention intensity): Both PAM and enhanced PAM received six 15‐ to 20‐minute calls regarding asthma symptoms and management for 4 months after the home visits. Enhanced PAM also received smoking cessation and a second round of SHS exposure feedback. | |
| Outcomes | Child exposure: 2 passive nicotine monitors (dosimetry) placed for 1 week during each of the 2 measurement periods (baseline and after call 5) ‐ 1 in the room where the child spends the most time and 1 worn by the child. Parent‐reported SHS exposure assessed by structured interview Child illness: asthma morbidity (numbers of asthma‐related hospitalisations, school days missed due to asthma, days with asthma symptoms, and Asthma Functional Morbidity Scale scores) Child health service utilisation: asthma‐related hospitalisations Target behaviour change: proportion of participants who quit; verified by expired air carbon monoxide testing at all follow‐up intervals | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Conflict of interest: none declared Source of funding: NIH grant R01 HL062165‐06 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Urn randomisation (form of adaptive biased‐coin randomisation) |
| Allocation concealment (selection bias) | Low risk | Allocation sequence could not be accessed by staff. |
| Incomplete outcome data (attrition bias) | High risk | Although no significant difference was seen in the counselling call completion rate, this rate was only 55% by 12‐month follow‐up. |
| Blinding of outcome assessment (detection bias) | Low risk | Objective measure used ‐ air nicotine |
| Other bias | High risk | • At baseline, comparison group (healthy children) was significantly different from the 2 intervention groups (PAM and enhanced PAM) with respect to child and parent age, cigarettes smoked per day, years smoked, nicotine dependence, and % household smoking ban. Note that randomisation only occurred for the 2 intervention arms. • Potential detection bias in that the half‐life of carbon monoxide is 4 to 6 hours, and so 7‐ and 30‐day point prevalence abstinence cannot be verified beyond that time frame. |
| Methods | Country: USA Settings: hospital and home RCT (3 arms) | |
| Participants | Inner city families with a child aged 6 to 12 years with asthma, residing with a smoker | |
| Interventions | Health coach/air clear group: two air cleaners and four 30‐ to 45‐minute nurse health coach home visits, and a behavioural intervention to reduce child second‐hand smoke exposure Air cleaner group: two air cleaners and 4 asthma education sessions Control group: asthma education during 4 nurse home visits | |
| Outcomes | Six‐month follow‐up from baseline: • Child urinary cotinine at baseline and at 6‐month follow‐up • Asthma symptom‐free days • Acute asthma healthcare events • Change in air quality • Caregiver smoking frequency and location | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in 1:1:1 ratio with random block sizes; randomisation performed by study co‐ordinator using the function in the database |
| Allocation concealment (selection bias) | Low risk | All study staff, including all investigators, were blinded to subsequent group assignment. |
| Incomplete outcome data (attrition bias) | Low risk | 91.3% followed up |
| Blinding of outcome assessment (detection bias) | Low risk | All study staff, including all investigators, were blinded to subsequent group assignment. |
| Other bias | High risk | Children randomised to the control group had caregivers who smoked significantly more at baseline and follow‐up than those in either intervention group. |
| Methods | Country: Hong Kong, China | |
| Participants | 80 parents of sick children presenting to a clinic or admitted to a children’s ward of a major Hong Kong hospital | |
| Interventions | Intervention: individualised motivational intervention for 30 minutes with nurse counsellor; appropriate stage‐matched intervention used to "increase motivation and lower resistance to quit"; telephone reminder 1 week after the intervention | |
| Outcomes | One‐month follow‐up: | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Retention: 77/80 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomized controlled trial"; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | Randomised after completion of questionnaire; no further information provided |
| Incomplete outcome data (attrition bias) | Low risk | Low loss to follow‐up: 77 (of 80) participants followed‐up successfully |
| Blinding of outcome assessment (detection bias) | Unclear risk | "At 1 month, trained interviewers who were blinded to the group assignment delivered telephone follow‐up calls to both groups to evaluate the primary and secondary outcomes using a standardized questionnaire." Self‐reported outcome only; bias possible |
| Methods | Country: Hong Kong, China | |
| Participants | 1483 mothers of sick children admitted to the ward or attending the outpatient department from all participating trial centres, November 1997 to September 1998 | |
| Interventions | Intervention: Mothers received information from nurses including standardised health advice, booklet about preventing child exposure to passive smoking, booklet to give to fathers on quitting smoking, a no smoking sign to place in the home to remind the father not to smoke, and a telephone reminder 1 week later. | |
| Outcomes | 3‐, 6‐, and 12‐month follow‐up: | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Retention: 1273/1483 (86%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random numbers were generated by the investigator using the computer and assigned to intervention (even) and control (odd) groups." |
| Allocation concealment (selection bias) | Low risk | "Nurses then randomized the subjects into the intervention or control group by opening a sealed envelope with serial numbers." |
| Incomplete outcome data (attrition bias) | Low risk | Low loss to follow‐up, ITT analysis used, similar percentage lost in both groups: 86% intervention and 85% control retention |
| Blinding of outcome assessment (detection bias) | Low risk | Self‐report only; differential misreport possible, but no difference found between groups, so unlikely |
| Other bias | High risk | Contamination of the control group possible: open ward setting "...the mothers in the control group could have by chance read the health education booklet from the mothers in the intervention group... furthermore, the nurses' health education could be easily overheard." |
| Methods | Country: Italy | |
| Participants | 218 women 30 to 49 years of age with children | |
| Interventions | Brief counselling and 3 gifts. Both groups received self‐help booklet. | |
| Outcomes | Reported smoking restrictions in home and car Change in smoking status reported | |
| Type of intervention | Well‐child (child health check) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table used |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | Low risk | 12 of 218 lost to follow‐up and ITT analysis performed |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not discussed for observer; objective measure not used |
| Methods | Country: Taiwan Setting: community (schools) Type: RCT | |
| Participants | 75 parent and child dyads in 6 elementary schools (grades 3 to 6); school was the unit of assignment | |
| Interventions | Intervention: Parent‐child dyads received an interactive programme comprising 3 weekly group sessions and 1 individual telephone counselling session 4 weeks after group sessions. Control: Written materials related to tobacco information were received by mail 4 times during the same time period instead of the intervention sessions. | |
| Outcomes | Child exposure: urine cotinine as well as parent and child reports of children's exposure to parental smoking Target knowledge change: Aims of intervention were to instil knowledge regarding the mechanism of the harmful effect of ETS, to correct people's perceptions of the smoking patterns that lead to ETS exposure at home, to introduce strategies for reducing ETS, and to assist parent‐child dyads in formulating strategies for maintaining a smoke‐free home. | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: National Science Council of Taiwan (NSC97‐2314‐B‐038‐043‐MY3) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | Low risk | 21% dropout rate |
| Blinding of outcome assessment (detection bias) | Low risk | Single‐blind; objective measure (cotinine) |
| Other bias | High risk | Selection bias: differences in participation rates between intervention and control groups. Non‐simultaneous collection of self‐reported data and urine cotinine levels during post‐test 2 may have caused inconsistency in the data. |
| Methods | Country: USA | |
| Participants | 103 mothers smoking ≥ 10 cigarettes/d with infants presenting to a well baby check | |
| Interventions | Urine was collected from all infants and analysed for cotinine. | |
| Outcomes | At 2 months, all participants were contacted to obtain a second urine sample from the infant for analysis. | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 56/103 (54%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly assigned by computer on an individual basis to intervention or control groups" |
| Allocation concealment (selection bias) | Low risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | High loss to follow up ‐ 43% control and 48% intervention; "however, it is unlikely that exclusion bias would mask a true impact of the intervention. Characteristics of those who complied were similar to those of the noncompliers... even with the reduced participation... the data were adequate to indicate that the response to the intervention was poor" |
| Blinding of outcome assessment (detection bias) | Low risk | Outcomes biochemically verified |
| Methods | Country: USA Setting: community (home and telephone) Type: RCT | |
| Participants | 300 underserved smoking mothers of tobacco‐exposed infants and preschoolers | |
| Interventions | Intervention: Behavioural counselling included 2 in‐home and 7 telephone sessions within 16 weeks. Home sessions aimed to offer skills training and modelled support for tobacco smoke exposure reduction efforts. Mothers also received 4 sections of written self‐help materials mailed at 2‐week intervals to supplement counselling content. Control: Participants mailed a single binder of written materials within a week of enrolment. Content was identical to the intervention group's 4 separate mailings. During telephone confirmation of receipt, staff provided a 5‐ to 10‐minute programme overview of the binder with brief advice and encouraged mothers to share materials with the family. | |
| Outcomes | Child exposure: maternal report and child urine cotinine Target behavioural change: biological (maternal saliva cotinine) to verify self‐reported smoking status, reported cigarettes smoked per day, reported tobacco smoke exposure, reported presence of other smokers in home, and total smoking ban in home | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: National Cancer Institute at the NIH (CA105183 and CA93756) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Block randomisation via small blocks of random length, stratified by child race, gender, and recruitment site. Method not specified |
| Allocation concealment (selection bias) | Unclear risk | After baseline completion, the intervention manager obtained group assignment via a secured Internet interface. Unclear whether this was concealed |
| Incomplete outcome data (attrition bias) | Low risk | Control group: 3% of allocated did not initiate control intervention, and a further 17% were lost to follow‐up Intervention group: 11% of allocated did not initiate treatment, and a further 19% were lost to follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Single‐blind and objective measure (cotinine) |
| Methods | Country: USA | |
| Participants | 143 Latino parents of children aged 1 to 9 who reported smoking at least 6 cigarettes a week | |
| Interventions | Intervention: 6 home and telephone sessions over a 4‐month period delivered by lay trained bicultural and bilingual Latina community health workers. Focused on problem solving aimed at lowering target child's exposure to ETS in the household. Intervention methods included contracting, shaping, positive reinforcement, problem solving, and social support to assist families in achieving their ETS goals. | |
| Outcomes | 3‐Month and 12‐month follow‐up: | |
| Type of intervention | Community‐based | |
| Notes | Retention: 127/143 (89%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized"; no further details given |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 81% provided data at all assessments, "and analyses showed attrition introduced no significant biases". |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: UK Setting: hospital (antenatal clinic) Type: RCT | |
| Participants | 1051 smoking 12‐ to 24‐week pregnant women who currently smoke 5 or more cigarettes per day and who smoked at least 10 cigarettes per day before pregnancy | |
| Interventions | Intervention: biochemically validated smoking cessation with transdermal nicotine patches (15 mg per 16 hours) for 4 weeks, followed by another 4 weeks if abstinent Control: visually identical placebo | |
| Outcomes | Child exposure: maternal self‐reported prolonged and total abstinence from smoking validated by exhaled CO and/or salivary cotinine Child illness: birth outcomes, infant impairment, infant respiratory symptoms up to age 2 Target behavioural change: smoking cessation | |
| Type of intervention | Well‐child (antenatal health check) | |
| Notes | Conflict of interest: NM reports personal fees from Novartis and personal fees from Elsevier, outside of the submitted work; TC reports personal fees from Pierre Fabre Laboratories, France, outside the submitted work. Source of funding: HTA programme project number 06/07/016 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Internet‐based randomisation that was stratified by recruiting site |
| Allocation concealment (selection bias) | Unclear risk | All pharmacists, research staff, and trial participants blinded to treatment allocations, but unclear about allocation concealment |
| Incomplete outcome data (attrition bias) | Low risk | By 2‐year follow‐up, 14% in NRT group and 15% in control group dropped out. |
| Blinding of outcome assessment (detection bias) | Low risk | Double‐blind and objective measure |
| Other bias | High risk | • Smoking data were not sought from all participants at predetermined time points, but were obtained opportunistically at multiple, different times between 8 and 54 months after childbirth, rendering smoking behaviour data difficult to interpret. • Smoking outcomes at 2 years were self‐reported, which may lead to bias; furthermore, these outcomes were not assessed in about 40% of participants. |
| Methods | Country: USA Setting: home Quasi‐experimental controlled study | |
| Participants | Pregnant women in rural counties (first‐time mothers) with follow‐up until the child was 12 months old | |
| Interventions | Intervention: home visits with the goal of promoting the health and development of first‐time mothers and infants (The Community‐Based Family Resource and Support (CBFRS) Program). The programme had 3 main foci: maternal health, child health and safety, and family functioning and parenting. Child's exposure to ETS was 1 part of this intervention. Control: received standard health department services that did not include home visits | |
| Outcomes | Mother's reported number of cigarettes smoked per day at baseline, and when infant was aged 6 and 12 months Numbers of hospital admissions and emergency room visits, and visiting health department clinics for well‐child care Knowledge: Mother asked 6 questions (a set) about the effect of smoking on her child's growth and development | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Part of a wider intervention federally funded programme, which also included several interventions unrelated to ETS | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not applicable |
| Allocation concealment (selection bias) | Unclear risk | Not applicable |
| Incomplete outcome data (attrition bias) | High risk | Overall dropout from analysis rate was fairly low (26%), but dropout rate was higher in the control group (dropout 49/205 intervention group, 43/150 in control group). Characteristics of dropouts as a whole are described. No intention‐to‐treat analysis was carried out. Under these circumstances, attrition bias is certainly possible. |
| Blinding of outcome assessment (detection bias) | High risk | Outcomes were assessed at interview by research staff, who were independent of the intervention staff. However, outcome assessors could very likely have been aware of which groups participants were in, as this was decided geographically, and blinding is not mentioned. The paper found a positive intervention effect. |
| Other bias | High risk | Not an RCT, so very open to selection bias ‐ significant difference in number of years of education between groups. Not much baseline questionnaire info provided, so unclear whether e.g. knowledge re smoking differed from the start between the 2 groups |
| Methods | Country: USA | |
| Participants | 303 self‐identified women smokers whose children received care at participating clinics | |
| Interventions | Intervention: During clinic visit, women received brief motivational message from the child’s clinician, a guide to quitting smoking, and a 10‐minute interview with a nurse or study interventionist. Women also received as many as 3 outreach telephone counselling calls from the clinic nurse or interventionist in the 3 months following the visit. | |
| Outcomes | 3‐Month and 12‐month follow‐up: | |
| Type of intervention | Mixed/not stated | |
| Notes | Retention: 81% at 12 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Participants "determined their randomization group by choosing a Ping‐Pong ball out of a brown paper bag. The bag contained several Ping‐Pong balls that were either white or yellow, and the color of the selected ball indicated their study group". |
| Allocation concealment (selection bias) | High risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | 19% lost at final follow‐up; counted as smokers. Similar numbers lost to follow‐up in both groups |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used in subset: "We determined the comparability of compliance with testing between the intervention and control groups and then examined the effect on self‐reported rates of abstinence of adjusting outcomes by the percentage of abstainers who tested above the cut‐off point." |
| Methods | Country: Australia Setting: community well‐child health clinic Type: RCT | |
| Participants | 1424 parents of children aged 0 to 4 years attending well‐child health checks | |
| Interventions | Interventions: Arm 1: • Computer‐delivered care ‐ tailored on‐screen information and a printed self‐help report regarding the risks of infant SHS exposure, how to reduce exposure risk, advice on quitting smoking, and contact details of the free quit line • Child health nurse‐delivered care ‐ During the subsequent clinic consultation, nurses provided a brief intervention focussing on risk reduction for the infant and offering NRT to parents/carers who were smokers. Contact details of the quit line were again provided, and nurses discussed the importance of complete home smoking bans, providing advice to address any barriers to their implementation. Arm 2: • Same as above, plus infant urine cotinine measured and results shared with parent, child health nurse, and their GP. A guide to preventing infant SHS exposure and strategies for quitting smoking were also included. Control: • Usual care from child health nurses | |
| Outcomes | Child exposure: Primary outcome: Parent/carer reported infant exposure to SHS, defined as a person smoking in the infant's presence in the past 3 days. At 12‐month follow‐up, if parent/caregiver reported the infant as NOT exposed, this was validated with urine cotinine test. Secondary outcomes: parent/caregiver smoking status and household smoking ban status of the home Target behavioural change: proportion who quit and proportion with complete household smoking ban | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Conflict of interest: unclear Source of funding: Financial Markets Foundation for Children, Community Health and Anti Tuberculosis Association, Centre for Health Research & Psycho‐oncology (CHeRP and infrastructure support from the Hunter Medical Research Institute) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Clinics were randomly assigned to 1 of 2 treatment arms or to a control arm via random number function in SAS statistical software. |
| Allocation concealment (selection bias) | Unclear risk | Services not blind to study allocation but unclear about allocation concealment |
| Incomplete outcome data (attrition bias) | Low risk | Between 11% and 15% lost to follow‐up or declined to participate at 12‐month follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Objective measure (cotinine) |
| Other bias | High risk | • Variability in quality and consistency of advice given to parents/caregivers to access NRT may bias the effect estimate towards the null. • Exposure misclassification; non‐smoking parents/caregivers had partners who smoked and this was not measured. Furthermore, self‐reported SHS exposure was not validated at baseline assessment. • Not blinded, meaning prone to detection and performance bias |
| Methods | Country: USA | |
| Participants | 630 smoking mothers with children younger than 6 years of age calling the helpline | |
| Interventions | Callers to a telephone smoking cessation assistance service were randomised to receive 1 of 3 self‐help guides. One was specifically written for the target audience, another was received from the American Lung Association, and 1 was developed by the National Cancer Institute. Callers to the line received individual stage‐based counselling and were sent the guide by mail. | |
| Outcomes | Six months later, the participant was called and was interviewed for 10 minutes about the use of the guide, opinion of the guide, quit attempts and strategies to quit, and current smoking. | |
| Type of intervention | Community‐based | |
| Notes | Retention: 630/873 (72%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quasi‐randomised: "Guides were assigned randomly to those in the target audience based on a preassigned list randomized by the day of the week." |
| Allocation concealment (selection bias) | Low risk | "CIS counsellors were blinded regarding which self‐help guides subjects would receive." |
| Incomplete outcome data (attrition bias) | Low risk | 28% lost to follow‐up; "completion rates were similar for subjects in the three guide groups" |
| Blinding of outcome assessment (detection bias) | Low risk | "Follow‐up interviews were conducted by trained interviewers who were blinded regarding subject assignment.... Surrogate interviews were conducted to verify the smoking status of those who reported that they had quit smoking..." |
| Methods | Country: USA Setting: community (Head Start programme) Type: RCT | |
| Participants | 330 caregivers (parent or legal guardian) of children aged 6 months to 6 years who reported 1 or more smokers living in the home and who spoke English | |
| Interventions | Intervention: motivational interviewing (MI) and education MI: over 3 months, offered caregivers 4 telephone counselling sessions (15 to 30 minutes in length each) plus 1 booster 15‐minute session after 3‐month assessment, for a total of 5 sessions Education: included EPA Smoke Free Home educational activities and materials as part of the Head Start programme, including staff training workshops about risks of and strategies for reducing SHS exposure, and expert facilitation of Head Start educational activities Control: education alone | |
| Outcomes | Child exposure: air nicotine, salivary cotinine, caregiver‐reported home smoking ban, and smoking cessation Target behavioural change: smoking cessation and home smoking ban | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: unclear Source of funding: National Heart Lung Blood Institute grant HL092901 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation scheme of groups of 10 to ensure equal group sizes. Use of random number generator |
| Allocation concealment (selection bias) | Low risk | Randomisation assignments were placed into sealed envelopes, which were opened after families completed baseline surveys. Research assistants who completed assessments were not masked to the intervention condition. |
| Incomplete outcome data (attrition bias) | High risk | 73% and 66% of the intervention group completed 6‐ and 12‐month assessments, compared with 85% of the education‐alone group completing both assessments. |
| Blinding of outcome assessment (detection bias) | Low risk | Not blinded but objective measure (cotinine) |
| Other bias | High risk | Misclassification bias; caregiver smoking status was not verified biochemically |
| Methods | Country: Turkey Setting: school with intervention including telephone calls RCT | |
| Participants | Parents of school children exposed to ETS aged 9 to 11 years attending a private primary school | |
| Interventions | Group 1: • Parents interviewed by a psychologist trained in smoking addiction Group 2: • Parents informed of child's urinary cotinine result through a letter | |
| Outcomes | Child urinary cotinine concentrations at 9 months from baseline | |
| Type of intervention | Community‐based | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were "randomly assigned", but method was not described. |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | Low risk | Full follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Biological measure used |
| Methods | Country: USA | |
| Participants | 96 elementary schools in 4 states | |
| Interventions | Trial of school‐based cardiovascular health promotion, including an intervention designed to limit child ETS exposure | |
| Outcomes | At 2 years: • School principals (or delegates) were surveyed with respect to their school's policy on tobacco and the degree to which the policy was observed. | |
| Type of intervention | Community‐based | |
| Notes | Retention: 96/96; this is the CATCH study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Ten schools at each site were randomly assigned to the control condition and 7 schools each to a school‐based intervention (food service, physical education, classroom curricula) or the school‐based plus family intervention program"; no further information given |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 100% of third grade teachers and 67% of students attended Family Fun Nights; 100% of schools remained in the dietary assessment process. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not specified |
| Methods | Country: USA | |
| Participants | 291 smoking parents (or grandparents) living with a child younger than 3 years old, recruited from hospital labour and delivery logs; community health centres and healthcare providers; self‐referral | |
| Interventions | Intervention: received a 30‐ to 45‐minute motivational interview at the parent's home with a trained health educator and 4 follow‐up telephone counselling calls (approximately 10 minutes each), aiming to reduce household ETS exposure and to increase the smoker's level of readiness for change. Feedback was provided on baseline household air nicotine, parent's CO level, and smoking‐related respiratory symptoms. Self‐help materials targeting ETS reduction and smoking cessation strategies were also provided. | |
| Outcomes | ETS exposure measured by air monitors at baseline and at 6 months | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 247/291 (85%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A computer‐generated randomization table was used." |
| Allocation concealment (selection bias) | Low risk | "Randomization information was kept from study staff until the baseline assessment was completed." |
| Incomplete outcome data (attrition bias) | Low risk | ITT analysis used; similar rates of follow‐up in both groups: 123/141 control, 124/150 intervention |
| Blinding of outcome assessment (detection bias) | Low risk | ETS exposure was measured by air monitors; results did not rely on self‐report. |
| Methods | Country: Norway | |
| Participants | 443 families with 1 or more smoking parent presenting with a child to a well baby check at 6 weeks or 2 or 4 years | |
| Interventions | Intervention: 5‐minute counselling from health visitor on harmful effects of parent smoking on children and how to prevent them (stop smoking indoors/in living rooms or quit completely). Three brochures distributed (harm of passive smoking, measures to prevent passive smoking, self‐help cessation manual) along with a list of smoking cessation courses | |
| Outcomes | Parent behaviour by self‐report at baseline and at 1 month | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention 363/443 (82%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly allocated"; method of sequence generation not specified |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | ITT analysis; exact numbers not provided: "The withdrawal was small and probably not intervention related because the proportion of drop‐outs was about the same in both groups" |
| Blinding of outcome assessment (detection bias) | Low risk | Self‐report only, no validation used; however no evidence of effect, so differential misreport judged to be unlikely |
| Other bias | Unclear risk | "A "contamination" of information may have taken place from the intervention group to the control group because parents from the two groups may have talked together during the study period." |
| Methods | Country: Sweden | |
| Participants | 41 mothers of newborn infants attending participating child health centres | |
| Interventions | Intervention: 'smoke‐free children' counselling provided by nurses | |
| Outcomes | 3 months: | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 100% for self‐report measures. Cotinine follow‐up measures: 85% intervention, 57% control | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | No randomisation used |
| Allocation concealment (selection bias) | High risk | No randomisation used, and further control centres recruited due to low participant recruitment at original control centres |
| Incomplete outcome data (attrition bias) | High risk | 100% retention for self‐report, but more participants refused to provide cotinine samples in control (57% provided cotinine) than intervention (85% provided sample) groups |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: USA Setting: recruited from the hospital postpartum unit. Intervention involved home visits and telephone calls by nurses. CT: intervention and control groups enrolled over different time periods | |
| Participants | Postpartum women who had quit smoking during their pregnancy | |
| Interventions | Intervention: motivational interviewing, one 15‐minute home visit and 2 subsequent phone calls for less than 15 minutes each Control: usual care, which involved a home visit by a nurse with no smoking intervention | |
| Outcomes | Final data collection 6 months from baseline Maternal self‐reported smoking status and salivary cotinine level | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | 71/219 attrition at 6 months | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not applicable |
| Allocation concealment (selection bias) | Unclear risk | Women in intervention and control groups had separate consents. |
| Incomplete outcome data (attrition bias) | High risk | Control group: 80% and 65% were available for data collection at 3 and 6 months, respectively Intervention group: 87% and 69% provided information at 3 and 6 months, respectively |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Other bias | High risk | Groups differed in marital status, depression scores, and previous quit attempts. |
| Methods | Country: USA | |
| Participants | 933 mothers (141 who smoked) of newborn babies | |
| Interventions | Factorial design, 'full' vs 'reduced' data collection. Full group visited at home when infants approximately 3 weeks old and had 2‐weekly telephone questionnaire. | |
| Outcomes | 'Full' subgroup was surveyed and urine was collected at baseline. Data were collected again in homes when infants were 7 and 12 months old. Data on lower respiratory symptoms were collected by telephone survey every 2 weeks, in full subgroup. | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Full data for 583/933 (62%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer‐generated list of random numbers" |
| Allocation concealment (selection bias) | Low risk | Allocation was performed by "a member of the administrative staff who was not involved with the conduct of the study". |
| Incomplete outcome data (attrition bias) | Low risk | Similar rates of follow‐up in both groups (67% intervention, 75% control) |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: USA | |
| Participants | 479 smoking mothers accompanying a child younger than 12 years to a hospital | |
| Interventions | Two intervention groups ('Child's Health Group' (CHG); 'Mother's Health Group' (MHG)) and a control group | |
| Outcomes | Maternal smoking status; stage of change; CPD; smoking location; knowledge of ETS effects at 6 months | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Retention: 232/479 (48%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random numbers table" |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | High loss to follow‐up (52% lost at 6 months), but "there were no significant differences between subjects who completed the 2 follow‐ups and other subjects in terms of... group assignment or any other baseline variable. Subjects lost to follow‐up were considered continuing smokers, using the “intent to treat” model of analysis" |
| Blinding of outcome assessment (detection bias) | Low risk | Self‐report only, but no evidence of effect shown, so differential misreport judged to be unlikely |
| Methods | Country: The Netherlands Setting: community well‐child centres Type: RCT | |
| Participants | 7775 parents of children aged 1 to 4 years | |
| Interventions | Intervention: If the child had recent asthma‐like symptoms, well‐child professionals provided an information leaflet and advised the parent to see a GP if not on treatment. If the child had already been treated by a GP or a paediatrician, well‐child professionals could refer them to an asthma nurse if symptom‐free; they were advised to see their GP if they experienced symptoms. If exposed to ETS, health risks of ETS exposure were discussed as well as whether parents could be motivated and prepared to stop exposing their child (house rules), and parents were given an info leaflet about preventing child ETS exposure. Control: routine practice, addressing the presence of general health symptoms and ETS exposure (at least at age 18 months). However, no specific or systematic assessments of asthma‐like symptoms and ETS exposure were performed. | |
| Outcomes | Child exposure: parent‐reported ETS exposure at home Child illness: parent‐reported physician‐diagnosed asthma (ever), current wheezing frequency and quality of life; also measured airway inflammation (exhaled NO, FeNO) and airway resistance (Rint) | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Conflict of interest: none declared Source of funding: Netherlands Organization for Health Research and Development (ZonMw: project no. 22000128). LD received funding by means of a European Respiratory Society/Marie Curie Joint Research Fellowship (MC 1226–2009) under grant agreement RESPIRE, PCOFUND‐GA‐2008‐229571. VWJ received additional grants from the Netherlands Organization for Health Research and Development (ZonMw ‐ VIDI). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 16 well‐child centres ranked on the basis of the socioeconomic status of their neighbourhood. Then centres in each subsequent couple were randomly assigned to intervention (n = 8) or control (n = 8) groups. Method of randomisation not stated |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | High risk | Response rate at first (71%), second (76%), third (72%), fourth (73%), and sixth (68%) years of life |
| Blinding of outcome assessment (detection bias) | Unclear risk | Parents not aware of research condition. However, unclear whether researchers measuring outcomes were aware of treatment group |
| Other bias | High risk | • Owing to possible contamination of intervention and control groups if families moved to other neighbourhoods and visited other well‐child centres, analyses were compared as both intention‐to‐treat and per‐protocol. • Sensitivity analyses were performed with and without multiple imputation to handle missingness. • Variation was evident in the way the intervention was delivered, with well‐child professionals tending not to repeat interventions that had been delivered at previous visits. • Information bias and misclassification were due to parental reports. |
| Methods | Country: USA Setting: school, with intervention at home RCT | |
| Participants | Children aged 3 to 10 years with diagnosed asthma attending preschool or elementary school in the Rochester City School District and their families | |
| Interventions | Intervention: motivational interviewing to counsel the primary caregiver about reducing smoke in the home and to provide brief smoking cessation counselling with the primary caregiver (if a smoker). Counselling of an additional household smoker who spends the most time with the child. Booster telephone calls at 1 and 3 months after counselling. Children received observed inhaler administered by a school nurse. Control: Participants were advised to contact their child's paediatrician regarding persistent asthma symptoms. | |
| Outcomes | Seven‐ to nine‐month follow‐up from baseline: • Child salivary cotinine • Asthma symptoms in peak winter season, November to February | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used blocked randomisation, 1:1 ratio, with scheme created by the biostatistics centre, stratified by smoking exposure at home |
| Allocation concealment (selection bias) | Unclear risk | Method of randomisation mentioned, but not clear whether allocation was adequately concealed |
| Incomplete outcome data (attrition bias) | Low risk | 5 withdrawals from each arm (N = 140 for intervention and N = 145 for control) |
| Blinding of outcome assessment (detection bias) | Unclear risk | Interviewers blinded but children's parents not blinded |
| Methods | Country: Germany Setting: recruited from maternity wards, with intervention at home RCT | |
| Participants | Mothers of neonates who smoked during pregnancy or quit shortly before pregnancy | |
| Interventions | Intervention: Counselling session based on motivational interviewing and relapse prevention and 2 telephone booster sessions 4 and 12 weeks after counselling Both groups received information brochures for themselves and their partners. | |
| Outcomes | Twenty‐four‐month follow‐up from baseline: • Proportion of mothers who quit • Proportion of mothers who did not restart smoking | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Allocated women to intervention or control, alternating the order on screening forms |
| Allocation concealment (selection bias) | High risk | Whether allocation sequences would begin with treatment or control condition was decided ad hoc. |
| Incomplete outcome data (attrition bias) | High risk | High number revoked participation after randomisation, and 25% were not followed up at 24 months. |
| Blinding of outcome assessment (detection bias) | Low risk | "The nature of our intervention made blinding impossible." But later says follow‐up assessment interviews were conducted by trained interviewers, who did not screen or counsel the women and were blind to the women's group membership. |
| Other bias | High risk | No ITT analysis |
| Methods | Country: Armenia Setting: community Type: RCT | |
| Participants | 250 households with non‐smoking mothers and at least 1 child 2 to 6 years of age living with at least 1 daily smoker | |
| Interventions | Intervention: in‐person counselling session with the non‐smoking mother and at least 1 daily smoker in each household, with distribution of a tailored educational brochure and demonstration of measurement of indoor PM2.5 (at second baseline visit); also included 2 follow‐up counselling telephone calls 1 and 2 months after the initial session. Intervention based on the motivational interviewing technique Control: brief educational leaflet on the hazards of SHS only | |
| Outcomes | Child exposure: children's hair nicotine and self‐report (questionnaire) Target behaviour change: smoking restriction Target knowledge change: health risks of ETS exposure | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: FAMRI (Flight Attendant Medical Research Institute) Center of Excellence in Translational Research at | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | 250 recruited households were assigned random numbers from 1 to 250; households with odd numbers were included in the intervention group, and those with even numbers were included in the control group. |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | High risk | 92% follow‐up, but only 56% provided hair samples for nicotine measurement |
| Blinding of outcome assessment (detection bias) | Low risk | Single‐blind; participants were unaware of their assignment status, the study hypothesis, and details of intervention and control group procedures |
| Methods | Country: Canada Setting: recruited from 5 public health nursing offices, 8 day care centres and kindergartens on Prince Edward Island. Intervention in the community RCT | |
| Participants | Parents with children younger than 5 years of age exposed to ETS | |
| Interventions | Group sessions held once a week for 3 consecutive weeks, followed by weekly telephone calls for 3 additional weeks Both groups received a brochure on ETS. | |
| Outcomes | Six‐month follow‐up from baseline: • Parent report on the average number of cigarettes smoked in the home daily • Implementation of a total ban on smoking in the household | |
| Type of intervention | Community‐based | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence with block sizes of 4 or 6 |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered opaque, sealed envelopes |
| Incomplete outcome data (attrition bias) | Low risk | 9/30 non‐attenders for intervention; ITT analysis done |
| Blinding of outcome assessment (detection bias) | Unclear risk | Phone interviews conducted and participants asked how they found the programme, so interviewer could not be blind |
| Methods | Country: USA | |
| Participants | 108 mothers smoking at least 2 CPD with child/ren < 4 years, using a supplemental nutrition programme | |
| Interventions | Intervention: Mothers given 7 individualised counselling sessions (3 in person, 4 by phone) designed to reduce child exposure to ETS. Mothers recorded their smoking and child's exposure and were given "no smoking" signs and stickers; at subsequent sessions, new objectives were set and positive feedback was given to mothers, when appropriate. Total duration: 3 months | |
| Outcomes | Child urine cotinine, reported exposure, parental smoking | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Retention: 96/108 (89%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random numbers were used to stratify assignments by three ethnic groups." |
| Allocation concealment (selection bias) | Unclear risk | "After the baseline measures, assistants opened an envelope to reveal assignments." No further information provided |
| Incomplete outcome data (attrition bias) | Low risk | ITT analyses; more losses to follow‐up in intervention than control groups (42/53 intervention provided 12‐month urine sample, 52/55 control provided sample) |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used "Measurement assistants were blind to group assignment. Control families were unaware of counselling procedures, and investigators were blind to results until all data were collected." |
| Methods | Country: USA | |
| Participants | 204 families with an asthmatic child from 3 to 17 years of age whose natural parent(s) were Latino or Hispanic, who lived with at least 1 smoker, and who reported exposure to at least 6 cigarettes the previous week | |
| Interventions | Intervention: asthma management education session delivered in the home, including generic advice to reduce child exposure to ETS. Follow‐up coaching consisting of 7 in‐home sessions of 30 to 45 minutes over 3 months plus follow‐up phone call | |
| Outcomes | At 4, 7, 10, and 13 months: | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Retention: 188/204 (92%). 11 participants dropped out before randomisation; 5 dropped out before outcome measurement. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "An Excel computer‐generated list of random 3‐digit numbers was constructed by clinic site." |
| Allocation concealment (selection bias) | Unclear risk | "Participants were assigned to the coaching condition and control condition based on numbers ending with even and odd digits." No further information given |
| Incomplete outcome data (attrition bias) | Low risk | ITT analysis conducted. Low dropout rate: 3 control families, 2 intervention families; "little or no sampling bias attributable to attrition" |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used "Control families were unaware of coaching procedures and continued in the study for measurement purposes only. Interviewers were blind to group assignment and investigators were blind to results until all data were collected." |
| Methods | Country: USA Setting: at home RCT | |
| Participants | Mothers who smoke, with children younger than 4 years | |
| Interventions | Intervention: 10 in‐person at‐home and 4 telephone counselling sessions over 6 months, with additional pre‐quit and post‐quit telephone sessions Control: referral to the free California Smoker's Helpline (usual care) | |
| Outcomes | Eighteen‐month follow‐up from baseline: • Children's urine cotinine concentration | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Recruited from the Supplemental Nutrition Programme for Women, Infants, and Children | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "random number list was used to assign pairs of participants matched on child's gender, ethnicity and recruitment site" |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | Low risk | 18‐Month interview 64/74 control group and 66/76 intervention group |
| Blinding of outcome assessment (detection bias) | Low risk | "Data collection research assistants were blind to group assignment, and control families were unaware of counselling procedures. Investigators were blind to results until all data were collected." |
| Other bias | High risk | However, "baseline children's urinary cotinine concentration was significantly higher among controls, indicating that randomization did not balance the groups with respect to cotinine". |
| Methods | Country: Canada | |
| Participants | 95 children admitted to hospital in the previous 5 years with asthma, along with their parents (not all smokers) | |
| Interventions | Intervention: cared for by a paediatric respiratory physician through the 12‐month study period. In addition, seen at clinic visits and visited at home by a nurse co‐ordinator who provided written information about asthma care and carried out an asthma educational session around lung and airway anatomy, asthma episodes, and treatment. Participant's home visited at least 3 times. Environmental exposures checklist drawn up; role of cigarette smoke discussed; parents discouraged from smoking in the home and encouraged to participate in a smoking cessation programme | |
| Outcomes | At 12 months: | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A process of restricted randomization based on age and number of previous hospitalizations during the previous 5 years was carried out. Subjects were alternately assigned to study or control groups, with the initial assignment for each pair determined by a coin toss." |
| Allocation concealment (selection bias) | Low risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | Low dropout ‐ 3 lost from each group |
| Blinding of outcome assessment (detection bias) | Low risk | Smoking status reliant on self‐report; however, no evidence of effect, so differential misreport judged to be unlikely |
| Methods | Country: Scotland | |
| Participants | 501 smoking parents of children with asthma | |
| Interventions | Intervention: brief advice from a nurse visiting the family home; information about passive smoking and asthma, financial and health benefits of quitting; information on how to stop smoking; advised to move to a different room or outside the home if they did not intend to quit; advised not to allow visitors to the home to smoke. Given 2 leaflets at baseline ‐ 1 commercially available, and the other provided to reinforce the brief advice. Questionnaires were completed. Further leaflets were distributed by mail at 4 and 8 months after baseline along with a letter encouraging them to stop smoking. | |
| Outcomes | At 12 months: • Child's saliva cotinine | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Retention: 435/501 (87%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomized"; no further information given |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 86.8% provided samples at follow‐up; percentage lost similar in both groups and reasons provided |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical measures used |
| Methods | Country: USA Setting: community (well‐child clinic) Type: observational, quasi‐experimental (historical control) | |
| Participants | Parents who smoke who have children aged 12 and 24 months; 40 parent‐child couples for intervention group and 40 for control group | |
| Interventions | Intervention: Children had serum cotinine measured with lead screening. Lab results were sent to providers and parents. The letter included an explanation that cotinine came from tobacco exposure, and that the normal value was zero. One week later, the tobacco counsellor proactively telephoned to explain the lab result, to describe potential sources of tobacco smoke exposure, including third‐hand smoke, and to convey what is known about the potential health effects of exposure for their child. Counsellor used motivational interviewing and cognitive‐behavioural therapy to engage the parent in a smoking cessation attempt. All parents were encouraged to institute a strict home and car no‐smoking policy, regardless of whether they wanted to stop smoking. If parent wanted to stop smoking, counsellors offered an 8‐session weekly telephone intervention based on an evidence‐based telephone smoking cessation protocol. While no prescription or over‐the‐counter medicine was offered, counsellors did describe them as options and facilitated access where requested. Control: historical group that received usual care | |
| Outcomes | Child exposure: outcomes assessed 8 weeks after initial call, including receipt of tobacco treatment, quit attempts, 7‐day point prevalent abstinence, and current home and car smoking policies Target behaviour change: receipt of tobacco treatment, parent quit attempts, 7‐day point prevalence abstinence | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Conflict of interest: unclear Source of funding: National Cancer Institute (R21CA137014) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Not randomised |
| Allocation concealment (selection bias) | High risk | Allocation concealment not possible, as the study was not randomised |
| Incomplete outcome data (attrition bias) | Low risk | 95% followed up |
| Blinding of outcome assessment (detection bias) | High risk | Not blinded |
| Other bias | High risk | • Recall bias as data ascertained historically in the comparison group • Misclassification, as smoking status not biochemically validated in control group |
| Methods | Country: Finland | |
| Participants | 1062 families presenting at a well baby clinic in Turku with a child 5 months old | |
| Interventions | Component of larger prospective intervention trial aimed at decreasing exposure of children to known environmental cardiovascular risk factors | |
| Outcomes | Follow‐up when child 8 years of age: | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 625/1062 (59%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Random numbers"; further details not provided |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | High but similar dropout rates in both groups overall (serum cotinine measured in 306/540 intervention and 319/522 control). However, attrition of smokers not quantified and attrition analysis not reported. Trial authors write: "It is possible that smokers have discontinued participation in STRIP more frequently than non‐smokers". |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: USA Setting: community (2‐1‐1 callers) Type: RCT | |
| Participants | 498 2‐1‐1 callers who were either smokers living with at least 1 child or other non‐smoker, or non‐smokers living with a smoker, and smoking was allowed in the home. Callers to 2‐1‐1 are disproportionately low income, unemployed, and uninsured, and have received fewer years of education relative to the general population. | |
| Interventions | Intervention: Smoke‐Free Homes intervention consisted of 3 mailings and 1 coaching call, based on a theme of "Some things are better outside", with content focused on 5 steps to create a smoke‐free home. The intervention was delivered over a 6‐week period at 2‐week intervals, first as a mailing, then as a coaching call, and finally as 2 additional mailings. The coaching call used motivational interviewing. Control: measures alone | |
| Outcomes | Child exposure: home smoking ban (self‐report), validated with air nicotine levels Target behaviour change: smoking away from home | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: unclear Source of funding: National Cancer Institute's State and Community Tobacco Control Research Initiative (U01CA154282) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 'Simple' (not block) randomisation, but method not described in detail |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 83.1% completed 3‐month data collection, and 79.1% completed 6‐month data collection. |
| Blinding of outcome assessment (detection bias) | Low risk | University‐based research assistants blinded to study condition collected outcome data at 3 and 6 months post randomisation; objective measure was also used. |
| Methods | Country: Japan | |
| Participants | Fifty children with mild atopic eczema/dermatitis syndrome and 25 normal children whose parents smoked 10 to 15 CPD at home | |
| Interventions | Intervention: not clear: “Parents of the cessation of passive smoking group agreed to stop smoking” | |
| Outcomes | At 1 month: | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Not provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly divided"; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | No information provided |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: USA | |
| Participants | 274 low‐income households including a child aged 4 to 12 years who had asthma recruited by media publicity, hospitals, and emergency departments | |
| Interventions | Intervention: high‐intensity intervention with community health workers providing in‐home environmental assessments, education, support for behaviour change (7 sessions), and a full set of resources | |
| Outcomes | Parent self‐report | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Retention: 110/138 (80%) in high‐intensity group and 104/136 (76%) in low‐intensity group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "We randomly assigned participants to groups using a permuted block design with varying block size." |
| Allocation concealment (selection bias) | Low risk | "Sequence numbers and group allocation were concealed in sealed, opaque, numbered envelopes prepared centrally and provided sequentially to interviewers." |
| Incomplete outcome data (attrition bias) | Low risk | "We performed an intention‐to‐treat analysis by using the baseline value of the outcome variable of interest as the exit value for participants who did not complete the study, which yields a conservative estimate of intervention effect." Similar follow‐up rates in both groups (110/138 intervention, 104/136 control) |
| Blinding of outcome assessment (detection bias) | Low risk | "The nature of the intervention made it impossible to blind participants and staff to group assignment." However, combination of objective and subjective measures, and all participants received visit from counsellor, so differential misreport unlikely |
| Methods | Country: USA | |
| Participants | 92 smoking parents of children with asthma | |
| Interventions | Intervention: Child's physician delivered a standardised passive smoking message to parents, consisting of counselling about the effects of passive smoking and advice to quit or smoke outside. Parents were given a specifically designed pamphlet that reinforced this message. About 1 month later, parents received a personalised letter from the principal investigator, containing the results and an explanation of their child's urine cotinine test. Included was a self‐help manual aimed at encouraging smoking outside. | |
| Outcomes | At 4 to 6 months: | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Retention: 72/92 (78%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Families were randomly assigned... at the time of enrolment using a coin toss method." |
| Allocation concealment (selection bias) | Low risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | Slightly higher dropout rate in control group than in intervention group (37/44 followed up in intervention, 35/48 followed up in control), ITT analysis not reported, but per‐protocol analysis more conservative in this instance, so judged to be at low risk of bias |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemically validated outcome |
| Methods | Country: USA Setting: hospital Type: RCT | |
| Participants | 119 parents or guardians of children receiving treatment for cancer who lived with at least 1 adult smoker and were exposed to SHS in the home or car setting | |
| Interventions | Intervention: multi‐component behavioural programme over 3 months; counselling consisted of 3 individual, face‐to‐face, biweekly 1‐hour sessions followed by 3 25‐minute telephone sessions for a total of 6 individual contacts with the counsellor. Parents also received letters from their child's physician at the start and at the end of the counselling phase to acknowledge their participation and progress. Control: standard care and equivalent follow‐up to intervention arm | |
| Outcomes | Child exposure (and target behaviour change): full smoking ban ‐ defined as a household with smokers that prohibited all smoking in the home and in the car | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Conflict of interest: none declared Source of funding: Grants CA085406 and CA21765 from the National Cancer Institute and the American Lebanese Associated Charities | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified, blocked randomisation scheme with strata including child's age and race, as well as smoking status of the participating parent |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 91% follow‐up rate |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not specified |
| Other bias | High risk | Reporting bias: smoking bans self‐reported, not validated biochemically |
| Methods | Country: Germany | |
| Participants | 40 mothers attending participating paediatric practice and self‐reporting smoked at least 10 CPD | |
| Interventions | All participants received a quit smoking information sheet and had urinary cotinine levels taken. | |
| Outcomes | At 6 weeks: | |
| Type of intervention | Mixed/not stated | |
| Notes | Nicotine consumption did not differ at baseline (median 12 μg for both). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Randomised by participant numbers (odd or even) |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | Low risk | Only 2 (of 40) missing at final follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: Spain Setting: community (primary paediatric care) Type: RCT (cluster) | |
| Participants | 1101 smoking parents of babies younger than 18 months | |
| Interventions | Intervention: brief intervention based on the '5 A's' approach, carried out during regular well baby visits at paediatric primary care team offices, lasting less than 10 minutes each time and with at least 3 occurrences: at baseline, at 3‐month follow‐up, and at 6‐month follow‐up Control: usual care | |
| Outcomes | Child exposure: hair nicotine level and parents' reported measures to avoid baby's exposure to tobacco smoke pollution at home, in the car, and in other settings Target behaviour change: smoking away from child in home, in car, or in other setting | |
| Type of intervention | Mixed (primary paediatric care includes both well‐ and ill‐child healthcare services) | |
| Notes | Conflict of interest: none declared Source of funding: Spain’s National Committee on Smoking Prevention (Comité Nacional de Prevención del Tabaquismo) and the | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised using SPSS version 15.0, with primary care teams as the unit of randomisation |
| Allocation concealment (selection bias) | Low risk | Not specified, but allocation was randomised by a central computer |
| Incomplete outcome data (attrition bias) | Low risk | 83% follow‐up rate |
| Blinding of outcome assessment (detection bias) | Low risk | Not blinded but biological measure (objective) |
| Other bias | High risk | • Groups were statistically significantly different at baseline. • Hawthorne effect/observer bias in control group |
| Methods | Country: USA | |
| Participants | Child aged < 36 months with a smoking caregiver presenting to the emergency department | |
| Interventions | Intervention group received brief education about third‐hand smoke; control group received "routine education" from the emergency physician | |
| Outcomes | Caregivers' change in smoking status or policies for smoking in the home or in the car | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | N = 40; 65% loss to follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | High risk | 65% loss to follow‐up from a small sample |
| Blinding of outcome assessment (detection bias) | Unclear risk | No information provided; objective measure not used |
| Other bias | High risk | Selection ‐ very small sample size, convenience sample; reporting of results unclear in terms of how numbers were derived and whether ITT analysis was performed |
| Methods | Country: USA Setting: hospital RCT | |
| Participants | Mothers who had previously smoked who had babies in the neonatal intensive care unit | |
| Interventions | Intervention: given information about bonding with the infant Both groups given handouts regarding second‐hand smoke exposure; neonatologist used motivational interviewing to prevent reuptake of smoking by the mother | |
| Outcomes | Eight‐week follow‐up from baseline: • Re‐uptake of smoking by mother, measured by self‐report, carbon monoxide oximetry, and salivary cotinine | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random table |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered opaque envelopes |
| Incomplete outcome data (attrition bias) | High risk | Salivary cotinine levels on only 67% of mothers who completed the study (45% from control and 55% from intervention) |
| Blinding of outcome assessment (detection bias) | Low risk | Biological measure used |
| Other bias | High risk | Small numbers ‐ intervention N = 24 and control N = 30. More mothers in the intervention than in the control group had private insurance (P = 0.02). Trend for infants in the intervention group to have lower birth weight (P = 0.08) and longer stay (P = 0.08). Insurance was found to be significantly associated with Kaplan‐Meier, remaining smoke free, and investigators tried to control for this. |
| Methods | Country: USA Setting: community (home and telephone) Type: RCT | |
| Participants | 348 expectant Latino couples (mothers and their male partners who smoked) | |
| Interventions | Intervention: culturally tailored couples‐based intervention plus written materials (self‐help smoking cessation guide) and free NRT Control: minimal intervention involving written materials plus NRT | |
| Outcomes | Target behaviour change: smoking cessation, measured by 7‐day point‐prevalence abstinence and 30‐day point‐prevalence abstinence at baseline, at the end of pregnancy, and 12 months post randomisation. Also assessed continuous abstinence and validated data with salivary cotinine from men | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: Grant R01CA127307 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Preset randomisation list stratified on whether men were daily or non‐daily smokers and first time fathers or not |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 81% follow‐up rate by 12 months |
| Blinding of outcome assessment (detection bias) | Low risk | Objective biological measure (unclear whether blinding occurred) |
| Other bias | Low risk | Social desirability bias is more common in Latinos, but this does not vary between intervention and control groups. |
| Methods | Country: USA | |
| Participants | Households with a child younger than 18 years of age and 2 adults, 1 of whom was a smoker | |
| Interventions | One culturally appropriate bilingual comic book for children and 2 fotonovelas for adults | |
| Outcomes | Reduced household smoking ‐ report and 2 nicotine air sampling monitors Self‐reported smoking status given (for the smoker) Increase in knowledge of health effects of SHS | |
| Type of intervention | Well‐child (child health check) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | High risk | 76 of 91 households completed 12 months of follow‐up; no ITT analysis stated |
| Blinding of outcome assessment (detection bias) | Low risk | Environmental nicotine monitors as outcome |
| Other bias | High risk | No ITT analysis. Air nicotine levels higher in intervention group but not significantly so |
| Methods | Country: USA Setting: recruited from postpartum units, intervention involved home visits Quasi‐experimental RCT | |
| Participants | Postpartum mothers who smoke and breastfeed infants | |
| Interventions | Intervention: educational intervention regarding "smoking hygiene" to reduce ETS exposure of infant. Education was delivered by a nurse, and participants were given an educational pamphlet. Air purifiers were provided. Control: data collection only | |
| Outcomes | Mothers completed a smoking habits questionnaire at baseline and at completion of the follow‐up period, 3 weeks later. Frequency of respiratory symptoms in the infant and hospitalisation were recorded at baseline and 3 weeks later. | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | 8/29 dropped out after enrolment. Follow‐up period was 3 weeks. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | High risk | Eight dropped out (25%), 4 from each arm ‐ very high attrition ‐ left 12 in intervention group and 9 in control group. No ITT performed |
| Blinding of outcome assessment (detection bias) | High risk | Data collector aware to which group participants were assigned |
| Other bias | High risk | Significant difference in numbers of cigarettes smoked during pregnancy between intervention (significantly higher) and control groups ‐ P = 0.26. No ITT analysis. Very small study |
| Methods | Country: USA Setting: hospital RCT | |
| Participants | Smoking caregivers of children hospitalised for respiratory illness | |
| Interventions | Intervention: counselling according to current clinical practice guidelines (US Public Health Guidelines: "Treating Tobacco Use and Dependence"). This includes nicotine replacement therapy. Control: received a brief antismoking message and referral to the state's quit line | |
| Outcomes | Six‐month follow‐up post hospitalisation: • Self‐report of parental smoking cessation • Parental quit attempts • Proportion reporting they set a quit date | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | High risk | High attrition but those lost to follow‐up treated as smokers. Unclear from which arm data are missing |
| Blinding of outcome assessment (detection bias) | Unclear risk | No information provided |
| Other bias | High risk | Very small study, so may produce spurious results ‐ only 20% of those eligible participated. Differences in baseline group measurement |
| Methods | Country: USA Setting: hospital RCT | |
| Participants | Tobacco smoking caregiver over 18 years of age with a hospitalised child | |
| Interventions | Intervention: brief intervention recommending tobacco cessation followed by referral to the state tobacco quit line and receipt of a smoking cessation brochure produced by the American Cancer Society. Both groups received an age‐appropriate injury prevention brochure. | |
| Outcomes | Primary outcome: Self‐reported quit status (defined as self‐reported abstinence for at least 1 week) Secondary outcomes: Decrease in cigarettes smoked per day; increase in importance of quitting on a 1 to 10 scale; report of any contact with state quit line | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers computer generated |
| Allocation concealment (selection bias) | Low risk | Sequential sealed envelopes used |
| Incomplete outcome data (attrition bias) | High risk | High level of loss to follow‐up (N = 19/60; 32%). However, ITT analysis was performed, and those lost to follow‐up were treated as ongoing smokers. |
| Blinding of outcome assessment (detection bias) | High risk | Telephone interviewers were not always blinded (but did have a script). |
| Methods | Country: Canada | |
| Participants | 251 mothers who had quit smoking during pregnancy | |
| Interventions | Intervention: Mothers received nurse‐delivered telephone support, relapse prevention training, and information resources. | |
| Outcomes | Self‐report of smoking status | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 238/251 (95%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Identification numbers randomly assigned to 2 groups, in blocks of 50, via a computer software package." |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) | Low risk | Similar rates of follow‐up in both groups at 12 months and 95% retention (238/251) |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used at in‐person follow‐ups (89% of participants) "Only 1.4% of the self‐reports of abstinence were contradicted by CO readings of ≥ 10 ppm; these women were classified as smokers." |
| Methods | Country: Netherlands | |
| Participants | 476 children seen to be at high risk of asthma recruited during the prenatal period | |
| Interventions | Intervention: 3 home visits (2 prenatal and 1 postnatal) with recommendations to reduce 4 main environmental exposures of mite allergens, pet allergens, food allergens, and passive smoking prenatally and postnatally | |
| Outcomes | Parent report of child ETS exposure | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 443/476 (93%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Prerandomisation; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | "To prevent contamination... the prerandomisation was performed in clusters, taking into account the post (zip) code of the domicile of the recruited family in |
| Incomplete outcome data (attrition bias) | Low risk | 93% retention; similar number completed follow‐up in both groups (222/242 intervention, 221/234 control); attrition and ITT analyses performed |
| Blinding of outcome assessment (detection bias) | High risk | Self‐report only: "reporting bias cannot be excluded as an explanation for the decrease in asthma‐like symptoms in the intervention group at age 2 yrs." |
| Methods | Country: Netherlands (nationwide) Setting: community (telephone) Type: RCT | |
| Participants | 512 smoking parents of primary school children aged 9 to 12 years | |
| Interventions | Intervention: up to 7 counsellor‐initiated telephone calls during a period of 3 months. All participants also received 3 books entitled "Smoke‐Free Parents". Booklets were sent at 3 time points throughout the study (immediately after the first call, 2 weeks after the first call, and 6 weeks after the first call). Time points corresponded with contents of the booklets (deciding and preparing, initiating and maintaining abstinence, and preventing relapse). Control: self‐help brochure, together with information on use of NRT and pharmacotherapy | |
| Outcomes | Child exposure: home smoking ban Target behavioural change: smoking cessation, measured by 7‐day point‐prevalence abstinence at 12‐month follow‐up, 7‐day point‐prevalence abstinence at 3‐month follow‐up, and prolonged abstinence (defined as report of 7‐day point‐prevalence abstinence at 3 and 12 months and report of cessation for at least 6 months at 12‐month follow‐up). Also measured use of and adherence to NRT and pharmacotherapy. Subsample of those reporting abstinence were biochemically validated using exhaled CO and salivary cotinine. | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: ZonMW, the Netherlands Organization for Health Care Research and Development (grant number: 50‐50110‐96‐639) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation sequence, in blocks of 10 to ensure equal group sizes, and stratified to ensure balance of key characteristics (gender, educational level, and cigarettes smoked per day) |
| Allocation concealment (selection bias) | Unclear risk | Independent researcher performed allocation of participants, but first trial author prepared mailings informing participants about the treatment they would receive. |
| Incomplete outcome data (attrition bias) | Low risk | 85.5% follow‐up in treatment group, and 91.8% follow‐up in the control group |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation (blinding not specified) |
| Methods | Country: USA | |
| Participants | 2901 mothers of newborn babies who had smoked before pregnancy (1875 smokers, 1026 non‐smokers at enrolment) | |
| Interventions | In the first 1 to 3 days after birth in hospital, mothers received a packet containing a brochure and a letter from the paediatrician about the health effects of passive smoking, along with a no smoking sign. | |
| Outcomes | Primary outcome: Assessment at 6 and 12 months by mailed questionnaire: • Knowledge of and attitudes towards ETS | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 2003/2901 (69%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Cluster‐randomised by practice; method not described |
| Allocation concealment (selection bias) | Unclear risk | Method of allocating practices not described. All eligible patients enrolled, "because the survey information was anonymous, and because smoking counselling was considered to be standard medical practice, the study was exempted from the requirements for obtaining informed consent". |
| Incomplete outcome data (attrition bias) | Low risk | Losses to follow‐up (31% in each group) assumed to have relapsed; attrition analyses performed |
| Blinding of outcome assessment (detection bias) | Low risk | No biochemical validation but cluster‐randomised by practice; followed up anonymously via survey; differential misreport unlikely |
| Methods | Country: USA | |
| Participants | Families with a smoker at home; infant in NICU at high respiratory risk | |
| Interventions | Motivational interviewing. There were three groups; motivational interviewing, usual care, and usual care‐reduced measurement. The motivational interviewing group had 2 hospital‐based sessions of approximately 40 minutes each, 2 personalised letters, and 2 phone feedback sessions targeting infant ETS reduction. Reduced measurement group refers to reducing follow‐up, as this is thought to affect the behaviour of the control group. | |
| Outcomes | Air nicotine monitors Infant end‐tidal carbon monoxide Self‐report measures of home and car smoking bans | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | In process of publication, information taken from a report | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | High risk | High degree of loss to follow‐up by 6 months (intervention 51/70 completed, usual care 21/34 completed, and usual care reduced measurement 28/40 completed) |
| Blinding of outcome assessment (detection bias) | Low risk | Air nicotine monitors used |
| Methods | Country: USA Setting: community (home) Type: RCT | |
| Participants | 242 parents or guardians of children aged 2 to 14 years with asthma from low‐income, predominantly ethnic minority families, living in households with at least 1 current smoker where smoking had occurred at home | |
| Interventions | Intervention: tailored Spanish/English video addressing implications of SHS exposure for children with asthma, possible efficacy of household SHS exposure reductions on the child's health and frequency of asthma attacks, and strategies to reduce household SHS exposure. A companion Spanish/English workbook was also provided to reinforce messages in the DVD and to encourage discussion among participating and non‐participating household members. Brief counselling consisted of asking participants to use the DVD and workbook only. Booster elements included a refrigerator magnet, a mug, and "no smoking" signs to serve as reminders. Control: received standard brochures describing the importance of SHS exposure as an asthma trigger | |
| Outcomes | Child exposure: self‐reported SHS exposure with two separate surveys of parents/guardians and children; urinary cotinine in children; passive air nicotine monitors in major activity rooms Child illness: child's asthma severity, asthma‐related quality of life Target behavioural change: reduced smoking in household (including smoking ban) | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: unclear Source of funding: National Institutes of Health grants HL53957 from the National Heart, Lung and Blood Institute, Division of Lung Diseases, and CA16042 from the National Cancer Institute | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not specified |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes with allocations opened after baseline data collection |
| Incomplete outcome data (attrition bias) | High risk | 76% follow‐up in intervention group and 70% in control group |
| Blinding of outcome assessment (detection bias) | Low risk | Unclear whether blinded, but objective air nicotine measure used |
| Methods | Country: USA | |
| Participants | Parents or guardians of children receiving treatment for cancer who lived with at least 1 adult smoker and were exposed to SHS in the home or car setting | |
| Interventions | Counselling (multi‐component behavioural programme) delivered by trained counsellors over 3 months ‐ 3 individual, face‐to‐face biweekly 1‐hour sessions followed by three 25‐minute telephone sessions. Parents received literature about SHS‐related health risks for children and for stress management. Did not involve formal cessation counselling. Standard care group given brief advice about removing child from sources of exposure, and advised about adverse health problems | |
| Outcomes | Parent‐reported child SHS exposure Child urinary cotinine Parent‐reported smoking | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Specific method used to achieve randomisation (e.g. computer‐generated random numbers, coin‐toss) not described. Stratified, blocked randomisation scheme with strata of child’s age (≤ 5, 6 to 12, 13 to 17 years), race (White, non‐White), and smoking status of the participating parent (smoker, nonsmoker) |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) | Low risk | 10/135 lost to follow‐up; ITT analysis |
| Blinding of outcome assessment (detection bias) | Low risk | Urinary cotinine as measure (objective) |
| Methods | Country: Germany Setting: community (home and telephone) Type: RCT | |
| Participants | 917 households with parents of children younger than 4 years of age, where at least 1 parent was a smoker | |
| Interventions | Intervention: 15 to 30‐minute in‐person behavioural change counselling session, a computer‐generated feedback letter (including the child's urine cotinine level), and a 5‐ to 15‐minute phone counselling session Control: received the same leaflet as the intervention group about the adverse effects of ETS on children. A letter containing information about the child urine cotinine level at baseline and 12 months later was sent after the 12‐month follow‐up assessment. | |
| Outcomes | Child exposure: child urine cotinine and self‐reported SHS exposure, smoking status, and home smoking ban Target behavioural change: home smoking ban | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: German Cancer AID (Deutsche Krebshilfe, grant no. 107539) and DZHK (German Centre for Cardiovascular Research), partner site Greifswald, Germany (grant no. 81/Z540100152) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not specified |
| Allocation concealment (selection bias) | Low risk | Screening team blinded to allocation and separate from intervention team |
| Incomplete outcome data (attrition bias) | Low risk | 89.7% follow‐up in intervention group; 96.4% follow‐up in control group |
| Blinding of outcome assessment (detection bias) | Low risk | Objective biological measure, although assessors of baseline and 12‐month follow up data were not blind to study group assignment |
| Methods | Country: USA Setting: hospital and well baby visits RCT | |
| Participants | Postpartum women with a history of smoking in the 30 days before pregnancy | |
| Interventions | Intervention: Initial nurse delivered relapse prevention counselling for 15 to 30 minutes. At 2‐week and 2‐ and 4‐month well baby visits with the paediatric provider, women received reinforcement if they had not restarted smoking. If they had restarted smoking, they were given encouragement and a plan to try to quit again. Control: received no counselling and "standard care" from the paediatric provider | |
| Outcomes | Follow‐up 6 months from baseline Proportion of mothers who maintain smoking cessation postpartum | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Had salivary cotinine at baseline only | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | Low risk | |
| Blinding of outcome assessment (detection bias) | Unclear risk | No information provided |
| Methods | Country: Italy | |
| Participants | 1015 parents of newborn babies (all mothers including non‐smokers recruited) recruited when attending the clinic for the 3‐month vaccination of the infant | |
| Interventions | Intervention: counselled for 15 minutes by a nurse on the health effects of active smoking and ETS, and given 3 booklets ‐ 1 of which was about the health effects of ETS on children | |
| Outcomes | At 2 and 4 years: • Self‐reported cessation | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 747/1015 (74%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Non‐randomized experimental design" |
| Allocation concealment (selection bias) | High risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | Similar follow‐up rates in both groups (304/402 intervention, 443/616 control). Participants who had moved away were excluded from analysis. |
| Blinding of outcome assessment (detection bias) | High risk | Self‐report only; differential misreport possible |
| Methods | Country: USA | |
| Participants | 91 families with children with asthma | |
| Interventions | Intervention: Parent and child attended a series of intensive counselling sessions over 6 months designed to reduce child's exposure to parental smoking. Diaries were used in the 2 weeks preceding visits to record parental smoking, child's ETS exposure, child's peak flow readings, and child's symptoms. These data were used for tailored counselling. | |
| Outcomes | At 6 months from end of intervention: • After debriefing about the study, the 2 comparison groups achieved similar reductions in parent‐reported rates of child exposure, and the intervention parent‐reported child exposure rate was similarly maintained. | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomized"; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Low risk | High rate of follow‐up at 12 months across all groups (28/31 intervention, 28/28 monitoring control, 26/32 usual care) |
| Blinding of outcome assessment (detection bias) | Low risk | Self‐report validated by environmental monitor |
| Methods | Country: Australia | |
| Participants | 292 smoking parents of children aged 1 to 11 with asthma | |
| Interventions | At baseline, urine analysed for cotinine:creatinine ratio | |
| Outcomes | At 6 months: • Smoking bans at home • Parent reports of bans on smoking in car • CPD • Parent‐reported cessation | |
| Type of intervention | Child with health problems (ill‐child health care) | |
| Notes | Retention 264/292 (90.4%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Families were allocated by alternate week to either an intervention or control group." |
| Allocation concealment (selection bias) | High risk | No information was provided, but method of sequence generation makes allocation concealment highly unlikely. |
| Incomplete outcome data (attrition bias) | Low risk | Similar rates lost to follow‐up in both groups (10.5% intervention, 8.7% control) |
| Blinding of outcome assessment (detection bias) | Low risk | Children's cotinine levels used to validate self‐report of smoking bans |
| Methods | Country: Australia and New Zealand Setting: community (home) Type: RCT | |
| Participants | 293 mothers of infants between birth and 5 weeks of age, when mothers self‐identified as Maori or Australian Aboriginal/Torres Strait Islander and mothers were current smokers, or the infant lived in a household with at least 1 smoker | |
| Interventions | Intervention: Mothers (and family members present) received usual care plus behavioural coaching about dangers of SHS exposure to children, commitment to smoking restrictions in the home/car, positive role modelling, and strategies for overcoming obstacles to making smoke‐free changes. Smokers also were offered brief advice or intensive counselling to quit and were offered free NRT and/or a quit line referral. Control: usual care, which included brief quit advice and the provision of smoking cessation treatment | |
| Outcomes | Child exposure: child urine cotinine, self‐report smoking restrictions in home/car, self‐reported SHS exposure, and self‐reported smoking cessation Child illness: parent‐reported cough in child Child health service utilisation: rate of health provider presentations and/or hospitalisations for new primary episodes of acute respiratory illness in the first year of life Target behavioural change: smoking cessation, restriction, and home/car smoking ban | |
| Type of intervention | Community‐based | |
| Notes | Conflicts of interest: All authors declare that (1) no trial authors have received support from any companies for the submitted work; (2) CB has previously undertaken research on behalf of NicoNovum, but before the purchase of the company by RJ Reynolds. NW has provided consultancy to the manufacturers of smoking cessation medications, received honoraria for speaking at a research meeting, and received benefits in kind and travel support from a manufacturer of smoking cessation medications. MG has provided consultancy to the manufacturers of smoking cessation medications; (3) their spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and (4) all trial authors have no non‐financial interests that may be relevant to the submitted work. NW, CB, MG, and VP have also undertaken 2 trials of very low nicotine content cigarettes, which were purchased from 2 different tobacco companies. The companies concerned had no role in development of the study design, data collection, data analysis, data interpretation, or writing of the trial publications. Source of funding: National Health and Medical Research Council of Australia (545203); the Health Research Council of NZ (09/626); Cure Kids NZ (3525); and the James Russell Lewis Trust, New Zealand (13787/15734) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised in a 1:1 ratio to 1 of 2 arms by central computer using block randomisation stratified by country |
| Allocation concealment (selection bias) | Low risk | Not specified, but allocation was randomised by a central computer |
| Incomplete outcome data (attrition bias) | Low risk | 88% follow‐up in intervention group and 86% follow‐up in control group |
| Blinding of outcome assessment (detection bias) | Low risk | Objective measure and single‐blind (research staff assessing the primary outcome were blinded to treatment allocation) |
| Methods | Country: China Setting: community (preschools) Type: RCT | |
| Participants | 65 caregivers (and children, but this Cochrane Review focuses on caregivers only) | |
| Interventions | Intervention: health education classes for children aimed at encouraging children to persuade their smoker caregivers to change their behaviours. Children were given a bookmark, a card, and a sign that said "no smoking" to act as reminders for their caregivers. Also children were given materials about quitting and ETS exposure to be shared with their caregivers. Smoking cessation and ETS exposure counselling for caregivers consisted of 1 lecture and 5 monthly in‐person counselling sessions at school over 6 months, together with educational materials and text messages. Child's urine cotinine level was fed back to caregivers. Control: Group underwent all assessments but did not receive counselling. | |
| Outcomes | Child exposure: child urine cotinine, self‐reported ETS exposure of children by caregivers, caregivers' self‐reported smoking status Target behavioural change: smoking cessation and reduced smoking in home or in presence of child | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: Postgraduate Research Fund of Central South University, China (Grant Number 2013zzts076) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Two‐stage simple random sampling (first stage: district drawn at random; second stage: preschool drawn at random); unit of randomisation was the individual family; computer‐generated randomisation table used |
| Allocation concealment (selection bias) | Low risk | Randomisation information was kept from the study counsellor until the baseline assessment was completed. |
| Incomplete outcome data (attrition bias) | Low risk | No loss to follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Lab staff blinded to intervention status; cotinine used as an objective measure |
| Methods | Country: UK | |
| Participants | 731 mothers who lived in deprived London districts and met the inclusion criteria after answering an information leaflet | |
| Interventions | Intervention Group 1: Support Health Visitor intervention consisting of monthly supportive listening visits to the mother's home, beginning when the baby was 10 weeks old. The primary focus was on the mother rather than on her child, as well as on providing practical support and information. | |
| Outcomes | Childhood injury, maternal depression, and smoking | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 601/731 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The allocation sequence was computer generated and minimisation was used to provide a reasonable balance on three potential confounders..." |
| Allocation concealment (selection bias) | Low risk | "Recruiters provided a centrally based administrator with the participant's name and information on the minimisation factors. These data were entered into the computer program to determine the participant's allocation." |
| Incomplete outcome data (attrition bias) | Low risk | Similar rates of follow‐up at 12 months in all groups (82% control, 85% community group intervention, 80% support health visitor intervention). Intention‐to‐treat analyses were performed. |
| Blinding of outcome assessment (detection bias) | High risk | Self‐report via postal questionnaire: "because of the nature of the interventions, it was not possible for either the trial participants or the researchers to be blinded to group allocation" |
| Methods | Country: USA | |
| Participants | 87 parents of children 3 to 12 years of age with asthma who were ETS exposed. (At baseline, 61% of intervention group maternal caregivers smoked vs 42% of controls.) | |
| Interventions | All children examined at baseline by a paediatric pulmonary specialist, and their treatment was adjusted as appropriate. | |
| Outcomes | At 12 months: • Acute asthma episodes • Hospitalisation • Prohibition of smoking in the home • CPD • Parent‐reported exposure of children and asthma control | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | Follow‐up cotinine data obtained in 51/87 (59%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomization design with blocks of length four"; no further information provided |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Unclear risk | Intention‐to‐treat analysis conducted; "attrition rates on the cotinine data were equivalent in the intervention and control groups" (25/44 intervention, 26/43 control) |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical measure used |
| Methods | Country: USA Setting: participants identified from insurer database, counselling intervention delivered in the community RCT | |
| Participants | Caregivers of children aged 3 to 12 years who have asthma and are exposed to second‐hand smoke | |
| Interventions | Three counselling visits, including cotinine feedback, and 3 follow‐up phone calls | |
| Outcomes | Twelve‐month follow‐up from baseline: • Child urinary cotinine:creatinine ratio • Child asthma‐related use of healthcare resources (asthma visits and medication use) • Home smoking bans • Caregiver smoking status | |
| Type of intervention | Child with health problems (respiratory disorders) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer algorithm used |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) | Low risk | Low loss to follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Study staff performing follow‐up blinded; asthma assessments blinded Biological measure used |
| Methods | Country: USA | |
| Participants | 101 mothers and fathers of newborns recruited on the postnatal ward who were current smokers or recent quitters | |
| Interventions | Intervention: A 15‐minute counselling session in person, enrolment in a proactive state quit line, follow‐up faxes to health professionals with tailored treatment measures | |
| Outcomes | 3‐Month follow‐up during which participant enrolment in the state smoking quit line was assessed and self‐reported smoking status was taken with a salivary cotinine level as confirmation of a self‐reported 7‐day point‐prevalence cessation | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 75% control and 69% intervention available for follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Participants were assigned to either the control or the intervention condition on the basis of the date the mother was admitted to the postpartum floor." |
| Allocation concealment (selection bias) | High risk | See above. |
| Incomplete outcome data (attrition bias) | Unclear risk | No significant difference in follow‐up between groups (75% control and 69% intervention); intention‐to‐treat analysis performed |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used |
| Methods | Country: Australia | |
| Participants | 184 parents of newborn babies whose mothers smoked during pregnancy | |
| Interventions | Intervention: Mothers in the maternity hospital were given an information kit about the effects of ETS on children and ways to quit smoking, along with a letter from the director of the Neonatal Intensive Care Unit urging parents to avoid exposing children to ETS. The kit was given to women by a research worker, who explained the material and answered questions. Women were telephoned at 1 month and were asked about their progress and use of the kit, and were given further information if required. | |
| Outcomes | At 3 months: | |
| Type of intervention | Well‐child (peripartum) | |
| Notes | Retention: 157/184 (85%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Non‐randomised; group assignment by month of admission |
| Allocation concealment (selection bias) | High risk | See above. |
| Incomplete outcome data (attrition bias) | Low risk | Similar and high rates of follow‐up in both groups (54/61 intervention, 57/62 control) |
| Blinding of outcome assessment (detection bias) | Low risk | Biological validation used |
| Methods | Country: Turkey | |
| Participants | 375 mothers with children attending well‐child clinic or with any primary complaint | |
| Interventions | Intervention 1: smoking cessation intervention aimed at child's health | |
| Outcomes | Maternal smoking status | |
| Type of intervention | Mixed/not stated | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Each mother was assigned the number of the questionnaire she filled in... Then the mothers were randomly assigned by a nurse who doesn't know anything about the study and the groups to one of three groups by randomly picking numbers form the list of questionnaire/mother numbers." |
| Allocation concealment (selection bias) | High risk | See above; breaking of allocation concealment possible |
| Incomplete outcome data (attrition bias) | Unclear risk | "12 (out of 375) families could not be contacted and were therefore excluded from the analysis." Unclear which groups those not reached came from. |
| Blinding of outcome assessment (detection bias) | High risk | No biochemical validation used; differential misreport possible |
| Methods | Country: Turkey Setting: community (home and telephone) Type: RCT | |
| Participants | 80 mothers of children aged 1 to 5 years who smoked and/or whose spouses smoked | |
| Interventions | Intensive intervention: consisting of 3 home visits, 2 telephone follow‐ups, and urine cotinine notification. Initial home visit provided brochures for whole family to read. Five behavioural change techniques were used: (1) providing information, (2) engaging in goal‐setting behaviour (not smoking in the home) and outcome (to reduce children's ETS exposure), (3) using follow‐up prompts, (4) educating to use prompts (i.e. "no smoking" warning signs in the home), and (5) providing environmental restructuring (i.e. removing ashtrays in the house). Control: minimal intervention comprising 2 home visits and urine cotinine notification | |
| Outcomes | Child exposure: urine cotinine; home smoking ban; number of cigarettes smoked in home Target behavioural change: home smoking ban | |
| Type of intervention | Community‐based | |
| Notes | Conflict of interest: none declared Source of funding: Ege University Scientific Research Projects Commission (Project No. 2009 Medicine 037) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stratified using SAS statistical programme. However, 12 mothers were substituted with other mothers due not wishing to participate, inability to collect child urine, or not meeting the participation criteria. Unclear if this was before or after randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) | Low risk | 97.5% follow up |
| Blinding of outcome assessment (detection bias) | Low risk | Objective cotinine measure (blinding not specified) |
| Methods | Country: USA | |
| Participants | 150 smoking mothers with children aged 4 or younger | |
| Interventions | Principal investigator and project co‐ordinator met with medical directors from each clinic to plan investigation implementation, then regularly throughout the study to "enlist participation and ongoing support". | |
| Outcomes | Mother report of smoking status and child's exposure to ETS | |
| Type of intervention | Well‐child (child health check) | |
| Notes | Retention: 128/150 (85%) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Assignment was stratified by child's age, ethnicity, gender, and clinic site. Random number lists were generated for each strata." |
| Allocation concealment (selection bias) | Low risk | "Within each group of four numbers corresponding to four participants in that strata, the first two even numbers were assigned to the experimental group." |
| Incomplete outcome data (attrition bias) | Low risk | Intention‐to‐treat analyses: "mothers who were lost to follow‐up and not measured were counted as smokers" 68/74 control and 60/76 intervention reached at final follow‐up |
| Blinding of outcome assessment (detection bias) | Low risk | Biochemical validation used "Research assistants who obtained measurements were blind to group assignment, and control families were unaware of counselling procedures." |
| Methods | Country: China | |
| Participants | 20,382 children in 44 primary schools | |
| Interventions | Intervention: A tobacco prevention curriculum comprising social and health consequences of tobacco use and training in refusal skills was introduced. Smoking control policies for schools were encouraged. Children in intervention schools wrote letters to their fathers to ask them to quit smoking and monitored their smoking behaviour. | |
| Outcomes | At 8 months: • Self‐report of smoking cessation by smoking fathers during interview with health educator | |
| Type of intervention | Community‐based | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | No randomisation reported |
| Allocation concealment (selection bias) | High risk | See above. |
| Incomplete outcome data (attrition bias) | Unclear risk | No information on missing data reported |
| Blinding of outcome assessment (detection bias) | High risk | Self‐report only; differential misreport possible |
5 As: Ask, Advise, Assess, Assist, Arrange.
BAM: Behavioural Action Model.
CBFRS: Community‐Based Family Resource and Support.
CHG: Child's Health Group.
CO: carbon monoxide.
CPD: cigarettes per day.
CT: controlled trial.
EPA: Environmental Protection Agency.
ETS: environmental tobacco smoke.
FeNO: fractional exhaled nitric oxide.
GP; general practitioner.
IgE: immunoglobulin E.
ITT: intention‐to‐treat.
MHG: Mother's Health Group.
MI: motivational interviewing.
min: minute(s).
NICU: neonatal intensive care unit.
NIH: National Institutes of Health.
NRT: nicotine replacement therapy.
PAM: Precaution Adoption Model.
RCT: randomised controlled trial.
Rint: interrupter resistance measurement.
SHI: smoking hygiene intervention.
SHS: second‐hand smoke.
SPSS: Statistical Package for the Social Sciences.
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Longitudinal study | |
| Wrong study design (no control group) | |
| Conference abstract only. Trial authors contacted and no further study information provided. | |
| Minimal data on smoking at either baseline or follow‐up, as smoking only a very small component of the intervention. | |
| Outcomes assessed by 2 surveys carried out before and after the campaign. This study targeted pregnant women. | |
| Wrong study design (no control group) | |
| Wrong study design | |
| Before‐and‐after study | |
| Abstract only; full paper included | |
| Quasi‐experimental historical comparison design. | |
| Uncontrolled study; no outcome data for control; only 3 versions of the intervention | |
| Conference presentation only | |
| Intervention aimed at preteens themselves, not at families or carers | |
| Wrong outcomes | |
| Abstract only | |
| Pre‐post study; not a controlled study | |
| Does not include outcome data related to ETS. | |
| Study protocol only | |
| Intervention targeted pregnant women and their non‐smoking spouses during the perinatal period only. | |
| This study targeted predominantly women, some of whom were mothers. | |
| Multiple‐baseline, quasi‐experimental design | |
| Does not include outcome data related to ETS. | |
| Longitudinal study | |
| Study objective to assess the impact of an intervention on parental smoking during pregnancy. | |
| Secondary analysis of an RCT of bupropion for smoking cessation | |
| Met main inclusion criteria, but the outcome measure was the report by kindergarten students of their intent to avoid cigarette smoke (by leaving the room themselves or asking an adult smoker to stop smoking). This outcome measure is believed by trial authors to be too unreliable for inclusion of this study. | |
| No ETS results published; this was an ongoing study from 2003 in the previous version of this Cochrane review (Baxi 2014); email contact with trial authors, no response. | |
| Pilot study only. No further results available. | |
| Pilot study only | |
| Study protocol only; full paper included | |
| Abstract only | |
| Intervention not described | |
| Wrong study design (no control group) | |
| Wrong patient population | |
| Baseline results only | |
| This ongoing study from 2005 was included in the previous version of this Cochrane Review (Baxi 2014); email contact with trial authors; no response | |
| Outcome data related to ETS not included, but data related to implementation of an intervention provided |
ETS: environmental tobacco smoke.
RCT: randomised controlled trial.
Characteristics of ongoing studies [ordered by year of study]
| Trial name or title | The study protocol for a randomised controlled |
| Methods | Parallel RCT |
| Participants | Indigenous women from Australia and New Zealand and their infants recruited from birth to 5 weeks age and followed‐up until 12 months of age, when the mother herself smokes or someone else in the household is a smoker |
| Interventions | Face‐to‐face home visits. Indigenous model of health promotion ‐ information provision, health education, behavioural coaching for women. For other smokers in the household ‐ smoking cessation advice, counselling, and treatment options |
| Outcomes | Infant medically attended acute respiratory illness Hospitalisations for infant acute respiratory illness Infant urinary cotinine Carer's self‐report of infant tobacco smoke exposure Carer's report of home and car smoking bans Carer's self‐report of smoking cessation Carer's self‐report of number of quit attempts Process indicators |
| Starting date | 2009 |
| Contact information | Vanessa Johnston |
| Notes | Dr. Johnston contacted on 28 June 2017, but no response. Study results not yet published |
| Trial name or title | Project zero exposure |
| Methods | Three‐stage approach: Stage 1 is intervention development, stage 2 is intervention pilot, and stage 3 is a cluster RCT. |
| Participants | Parents who smoke with a child younger than 3 years of age |
| Interventions | Developing a theory‐based intervention based on social marketing ‐ try to convince to stop smoking, (or) stop smoking around the child. Will have group support sessions, feedback of biochemical result of child tobacco smoke exposure, project website, video simulation game, and study information given to the participant's physician |
| Outcomes | Child tobacco smoke exposure assessed by hair nicotine Parental report of child tobacco smoke exposure Adoption of voluntary home and car smoking bans Child respiratory symptoms Parental smoking cessation |
| Starting date | Unclear |
| Contact information | Dr. L. J. Rosen |
| Notes | Dr. Rosen contacted on 28 June 2017; study results not yet available |
| Trial name or title | Novel methods to reduce children's secondhand smoke exposure I |
| Methods | RCT |
| Participants | Carers of children (3 to 11 years of age) who smoke and who are not interested in quitting |
| Interventions | Three arms: Participants receive electronic cigarettes, dissolvable tobacco lozenges, or dissolvable nicotine lozenges (Nicorette) for use instead of cigarettes when in the presence of their child(ren) for up to 8 weeks. |
| Outcomes | Primary outcome measures: • Change in child salivary cotinine [Time Frame: 2, 4, 8, and 12 weeks] • Child salivary cotinine measured to assess the level of second‐hand smoke exposure. We will measure the change throughout the study. • Change in parent and child lung function [Time Frame: 2, 4, 8, and 12 weeks]. We will collect both parent and child spirometry data and will compare changes. |
| Starting date | April 2012 |
| Contact information | Theodore L. Wagener; theodore‐[email protected] |
| Notes | Contacted trial author; currently analysing data; no published manuscripts yet |
| Trial name or title | PREPASE (PREvent PAssive Smoke Exposure) |
| Methods | RCT |
| Participants | Families with children (birth to 13 years of age) having an asthma predisposition who experience passive smoke exposure at home |
| Interventions | A motivational interviewing tailored programme including urinary cotinine feedback with 6 sessions; based on the principles of the reasoned action model |
| Outcomes | Primary outcome measure: • Percentage of families curtailing passive smoking exposure in children (parental report verified with urine cotinine concentrations of children) after 6 months Secondary outcome measures: • Household nicotine level • Child’s lung function, airway inflammation and oxidative stress, presence of wheezing and questionnaires on respiratory symptoms, and quality of life. |
| Starting date | Unclear |
| Contact information | On paper: contact via Sasha Hutchinson |
| Notes | Dr. Hutchinson contacted on 28 June 2017; no response |
| Trial name or title | Baby's Breath |
| Methods | RCT |
| Participants | Pregnant women (not more than 16 weeks pregnant; spoke English and at least 18 years old) who are smokers, spontaneous quitters (women who quit on their own without project materials) or smoke‐exposed, not pregnant with more than 1 baby, and have access to a working telephone and VCR/DVD player |
| Interventions | A series of 5 tailored videos and newsletters addressing issues of tobacco smoke avoidance, including smoking cessation, were compared with written materials containing no tobacco‐related content. |
| Outcomes | The primary outcome measure is foetal exposure to ETS during pregnancy and in the infant at 6 months of life (salivary cotinine and self‐report). Other impact measures included were psychosocial variables used to assess possible determinants of ETS. Self‐reported outcomes and most impact variables were assessed at 16 and 32 weeks of pregnancy, and at 3 and 6 months postpartum. |
| Starting date | Unclear |
| Contact information | Patricia Risica; [email protected] |
| Notes | Dr. Risica contacted on 28 June 2017; no response |
ETS: environmental tobacco smoke.
RCT: randomised controlled trial.
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1 Main outcomes Show forest plot | Other data | No numeric data | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Analysis 1.1
Comparison 1 Results, Outcome 1 Main outcomes. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
| Study | |
| Abdullah 2005 | Counselling strategies based on the stages of change component of Prochaska's transtheoretical model. Results as N (%), intervention N = 444, control N = 459. Biochemically validated quit rate: Intervention 47 (10.6) Control 21 (4.5) No measure of children's exposure or absorption via cotinine. |
| Abdullah 2015 | ETS exposure: 6 month follow‐up: 1) higher proportion of the intervention (62%) than the comparison (45%) group households adopted complete smoking restrictions at home (P = 0.022); 2) higher proportion of the intervention (38%) than the comparison (17%) group households did not smoke at home at all (P = 0.002); 3) total exposure from household members inside home in the past 7 days (measured by mean number of cigarettes smoked per week in front of the child by household members) was lower in the intervention (3.29) than the comparison (7.41) group (P = 0.021); 4) total exposure from all smokers indoors and outdoors in the past 7 days (measured by mean number of cigarettes smoked per week in front of the child) was significantly lower among children in the intervention (15.2) than the comparison (25.7) group (P = 0.005); 5) Comparison group: mean cotinine levels increased from baseline to 2 months and maximum at 6 months, with no statistically significant difference in time effects. Intervention group: mean cotinine levels increased at 2 months from baseline level but decreased again at 6 months, with statistically significant difference in time effects only from 2 to 6 months (P < 0.05); 6) No significant difference in allowing others to smoke around the child (P = 0.908). Air quality: At 6 month follow‐up: 1) mean number of cigarettes smoked daily was significantly lower in the intervention (11.02) than the comparison (13.6) group (P = 0.021); 2) significantly more participants in the intervention (48%) than the comparison (28%) group reduced the number of cigarettes smoked at home daily (P = 0.006) Child health: Perceived overall respiratory health of the child improved significantly in the intervention (35%) than the comparison (20%) group (P = 0.024). There were no significant differences in the reports respiratory symptoms of the child (P = 0.258). |
| Armstrong 2000 | Targeted disadvantaged mothers. Smoking in house around infant (maternal self report verified by researcher observation during home visit) included education about smoking near infants as a Sudden Infant Death Syndrome (SIDS) prevention strategy in a post‐natal nurse home visiting programme aimed to improve the quality of maternal‐child attachment, maternal health and child health parameters. At four months the intervention group had significantly more completed immunizations than the controls, although both groups had high immunization rates. At 12 months there was no statistically significant difference between the groups for immunization status. There was also no significant difference at four or 12 months for rates of utilisation of community services. |
| Baheiraei 2011 | Motivational Interviewing used. In 3 months geometric mean urinary cotinine: intervention decreased from 48.72 ng/mg to 28.68 ng/mg, control decreased from 40.43 to 36.32 ng/mg, differences between two groups statistically significant using one tailed t‐test. Greater decrease in total daily cigarette consumption in the presence of child in the intervention group than the control group (statistically significant with one tailed t‐test). Intervention median cigarettes at 3 month 0 (IQR 1 to 2.71), control 1 (IQR 0 to 3.21). Home smoking bans: intervention 15% to 33.3% (statistically significant increase), control 11.5% to 19.5% (not statistically significant increase), differences between two groups statistically significant using a one tailed t‐test. Car smoking bans in the intervention group increased from 4% to 8%, and didn't change in the control group. This was not a statistically significant difference. |
| Blaakman 2015 | ETS exposure: 5 months after discharge from NICY, caregivers in treatment group were sig more likely to report a home smoking ban than the comparison group (96% vs 84%; P = 0.03), and less likely to report routine infant contact with a smoker (40% vs 58%, P = 0.03). Differences in reported home bans (92% vs 83%, P = 0.14) and routine infant contact with smokers (44% vs 53%, P = 0.33) were no longer significantly different at study end (8 months after NICU discharge). No difference in car smoking bans or total smoking bans at any time. 8 months after NICU discharge, infants in intervention group had lower salivary cotinine and a greater decrease in salivary cotinine since baseline than infants in the comparison group. Air quality: Overall, very few caregivers quit smoking, which didn't differ between groups after intervention or at study end. Of the 29 total caregivers who reported smoking 5 months after NICU discharge, caregivers in the intervention group reported significantly higher confidence to quit than smoking caregivers in the comparison group at the 5‐month survey, but not at study end. No significant difference between groups in caregiver motivation to quit. Child health: No significant differences between groups in respiratory symptoms or use of health care services. |
| Borrelli 2010 | Latino families targeted. Used two interventions with different theoretical frameworks: one intervention used motivational interviewing, whilst the other intervention used the social cognitive theory. At 3 months 61.7% home monitors were returned and 98.8% were in good condition, whilst 60.9% child monitors returned and 100% in good condition. Household air nicotine significantly decreased from pretreatment to the 3 month follow‐up in the BAM condition, (baseline M = 1.07, SE 0.19, and 3‐month M = 0.28, SE 0.11, P = 0.01), whereas the decrease observed in the PAM condition was not statistically significant. Changes in secondhand smoke concentrations as assessed by the child monitors were not statistically significant. Continuous abstinence at 3 months 12.3% BAM group and 19.1% PAM group (OR 1.68, 95% CI 0.64 to 4.37). The child's level of functional morbidity due to asthma decreased significantly (P < 0.001) in both groups over time. Secondhand smoke exposure as measured by monitors directly on the child did not show a significant decrease in either group. |
| Borrelli 2016 | ETS exposure: SELF‐REPORTED: 1) PAM had significant reductions over time on one SHS exp variable, while HC had reductions on 4 of the 5 SHS exp variables, with a significant group x time interaction. 2) Enhanced PAM showed sig within‐group decreases in SHS exp over time on all 5 variables and HC showed sig within group decreases in SHS exp over time on 4 of the 5. Sig group x time interaction, such that enhanced PAM showed greater decreases in SHS exp over time versus HC for 3 of the 5 SHS exp variables; 3) Comparing PAM with enhanced PAM, no significant group x time interaction. OBJECTIVE: 1) No significant differences in levels of SHS exp at baseline; 2) At follow‐up, there were significant differences in detectable levels of SHS exp in the HOME monitors (PAM 92.1% vs HC 97.2%, P = 0.04), but NOT the CHILD monitors (PAM 91.4% vs HC 95.6%); 3) At follow up, no significant between‐group differences in detectable levels of SHS exp in either the home or child monitors, when comparing PAM with enhanced PAM. Air quality: 1) PAM more than 2x as likely to achieve 7‐day and 30‐day point‐prevalence abstinence than HC (statistically significant); 2) Enhanced PAM more than 2x as likely to achieve 7‐day PPA, 3x as likely to achieve 30‐day PPA than HCs, and 5x as likely to be continuously abstinent than HCs (statistically significant); 3) At 4‐months, enhanced PAm were more than 2x as likely to achieve 30‐day PPA versus PAM (significant). Child health: 1) At 6‐months, enhanced PAM had significantly lower child asthma hospitalisations than PAM; 2) At 2, 4 and 6 month follow‐up, enhanced PAM had sig lower missed school days due to asthma than PAM; 3) Odds of at least 1 day with asthma symptoms was sig lower in enhanced PAM than PAM at 6‐months; 3) No sig diff between groups in changes in asthma functional morbidity. |
| Butz 2011 | Low income households targeted. No statistically significant differences in urinary cotinine between baseline and follow up by group After combining the air cleaner groups, children assigned to those groups had a significant increase in symptom‐free days (SFDs) during the past 2 weeks (1.36 SFDs) compared with 0.24 SFDs for control group children from baseline to follow‐up No statistically significant differences In air nicotine at baseline and follow‐up by group Comparison of the combined air cleaner groups and the control group indicated that the combined air cleaner groups had significant mean differences in PM2.5 and PM2.5‐10 levels from baseline to follow‐up (mean differences for PM2.5: control, 3.5 [SD, 20.0]; combined air cleaner groups, ‐18.0 [SD, 33.2; P 0.001]; and for PM2.5‐10: control, 2.4 [SD, 20.8]; combined air cleaner groups, ‐9.6 [SD, 16.0; P = 0.009]) |
| Chan 2005 | Motivational Interviewing used. No statistically significant evidence of effect. |
| Chan 2006a | Fishbein's theory of reasoned action and Ajzen's theory of planned behaviour used in the development of the educational intervention. Three most frequently reported actions taken by the mother to protect the child from passive smoking at home: opening the windows (N = 641, 43.9%), asking the father not to smoke near the child (N = 608, 41.6%), and moving the child away from the smoke (N = 482, 33%). |
| Chellini 2013 | Post‐intervention smoke free homes were not significantly different between groups (increased in both): percentage increase in intervention group 12.7% and control group 11.1% (OR 1.04, 95 CI 0.47 to 2.28) . For cars: intervention group 18.2%, and control group 12.0% (OR 1.47 95 CI 0.69 to 3.11. Of the N = 131 smokers there was no significant difference in change of smoking habits. between intervention and control group (7% total stopped smoking, 5% stopped smoking indoors and n = 9 stopped smoking in the car). |
| Chen 2016 | ETS exposure: After intervention, the percentage of children with a urine cotinine concentration higher than 6ng/ml (indicating exposure) in the intervention group was significantly lower than that in the control group at both 8 weeks (P < 0.0001) and 6 months (P = 0.007). Air quality: Significantly less smoking in presence of children in intervention group at both 8 weeks and 6 months. Child health: N/A |
| Chilmonczyk 1992 | No evidence of effect. |
| Collins 2015 | ETS exposure: Associated with lower child urine cotinine compared with the control group. Air quality: Twenty (18.3%) of intervention group mothers and three (1.9%) of the control group mothers had bioverified quit status) P < 0.01). Child health: N/A |
| Conway 2004 | Participants (Latino families) for this study were recruited through advertising at community organisations and venues. Social learning model used. No significant effect. |
| Cooper 2014 | ETS exposure: N/A Air quality: After delivery, there were no statistically significant differences in cessation; self‐reported abstinence at 2 years was 2.9% in the NRT group and 1.7% in the placebo group. However, few participants reported using a full 8‐week course of NRT; 7.2% in NRT group and 2.8% in placebo group used their trial medications for over 1 month. Child health: At birth, significantly more Caesarian births occurred in the NRT group (20.7% vs 15.3%); at 2 years, significantly more infants in the NRT group (72.6% vs 65.5%) survived with 'no impairment'; 3) However, no sig difference between groups in infants' reported respiratory problems. |
| Culp 2007 | At 12 months the intervention group smokers smoked mean 2.1 fewer than control, which was not statistically significant: intervention 7.28 (s.d. 6.79), control 9.41 (s.d. 7.09) (t(147) = 1.82, P = 0.071). There were no significant differences between groups on number of hospital admissions or emergency room visits. At 12 months, intervention mothers were more likely to make use of health department clinics for well child care as compared to control group (chi square P =0.04) Knowledge of secondhand smoke exposure on child development: at 12 months significantly more intervention (N = 90, 58.1%) than control (N = 51, 47.7%) knew about SHS and impaired brain development, and significantly more intervention (N = 126, 80.6%) than control (N = 77, 72.0%) knew it takes longer to get well. No other significant differences with questions. |
| Curry 2003 | Ethnically diverse low income women targeted. Motivational Interviewing used. Abstinence rates: 3 mth Intervention 7.7% vs Control 3.4%; 12mth Intervention 13.5% vs Control 6.9% ‐ 12 mth difference statistically significant. Validation of smoking cessation by carbon monoxide expiration was completed by only a small subsample (13/156 in the intervention group and 5/147 in the control group). |
| Daly 2016 | ETS exposure: At 12 month follow‐up, 13% of all infants were reported to be exposed to SHS; however with urine cotinine validation, 17% overall were exposed. No significant time by group difference detected from baseline to follow‐up for either of the 2 treatment arms when compared with the control group. Air quality: At follow‐up, 47% of all parent/carers reported they were smokers. No significant time by group differences detected comparing either treatment arm with the control group. Child health: N/A |
| Davis 1992 | This study recruited participants through an advertising campaign that invited them to call a telephone smoking cessation assistance counselling service run by the National Cancer Institute in the USA. No evidence of difference between self‐help guides. |
| Eakin 2014 | ETS exposure: Differences in salivary cotinine were not significant. However, among all families who reported a home smoking ban, salivary cotinine and air nicotine levels declined in both groups (P < 0.05). Air quality: Participants in the MI and education group had significantly lower air nicotine levels (0.29 vs 0.40 mg), 17% increase in prevalence of caregiver‐reported home smoking bans, and a 13% decrease in caregiver smokers compared with education‐alone group (all P values < 0.05). Child health: N/A |
| Ekerbicer 2007 | This study from Turkey recruited ETS exposed children from a primary school. Parents of identified children received telephone counselling or a note regarding their child's urinary cotinine result. At 9 months follow‐up: Group one 74/93 students had urinary cotinine levels < 10 ng/ml; group two 69/93 had urinary cotinine < 10 ng/ml. "The proportion of children with urinary cotinine values < 10ng/ml were statistically similar (P > 0.05) in both groups". |
| Elder 1996 | Social learning model used. No evidence of effect on tobacco‐free school policy after 3 years: |
| Emmons 2001 | Motivational Interviewing used. Quit rates: Intervention 7.5%, Control 10.1%, P > 0.05 |
| Eriksen 1996 | No evidence of effect. |
| Fossum 2004 | Social learning model used. Self‐reported smoking (number of cigarettes) 1 month before childbirth: Intervention 13.1 vs Control 10.8 NS; 3 months after childbirth Intervention 12.8 vs Control 8.2 (significant); Past 24 hrs Intervention 11.8 vs Control 7.8 (significant). |
| French 2007 | Six month follow‐up data Saliva cotinine verified non smoker: intervention (N = 26, 22%), control (N = 9, 10%) ‐ P < 0.025 Self‐reported non‐smoker: intervention (N = 40, 33%), control (N = 21, 22%) ‐ P < 0.10 |
| Greenberg 1994 | Social learning model used. Targeted ETS exposure in infants less than six months of age, and aimed to reduce the incidence of lower respiratory tract illness and the prevalence of respiratory symptoms. For infants of smoking mothers it demonstrated a lower prevalence of persistent symptoms in the intervention group (17.8%) compared with control group (30.9%; risk difference 13.1%; 95% CI: 1.0 to 27.0%). There was no difference in the incidence of illness. |
| Groner 2000 | No evidence of effect. |
| Hafkamp‐de 2014 | ETS exposure: No significant difference in ETS exposure at home between intervention and control groups at age 6 years in the intention to treat analyses (OR 0.82, 95% CI: 0.66, 1.03); though this reached statistical significance in per‐protocol analysis with intervention group having less ETS exposure at age 6 years than the control group (OR 0.71, 95% CI: 0.59, 0.87). No effect modification by sociodemographic characteristics (data not shown). Air quality: N/A Child health: No significant differences between groups in asthma, wheezing frequency, airway inflammation (exhaled NO), or airway resistance (Rint). |
| Halterman 2011 | Motivational Interviewing used. Symptom‐free days/2 wk (difference) 0.96 (95% CI 0.39 to 1.52) |
| Hannover 2009 | Motivational Interviewing used. At 24 months follow‐up Sustained abstinence: intervention (N = 36, 12%, 95% CI 8.8 to16.2), control (N = 39, 11%, 95% CI 8.4 to15.1), no statistically significant difference in proportions (0.7, 95% CI ‐4.2 to 5.8) Four week point prevalence: intervention (N = 72, 24% 95% CI 19.6 to29.2), control (N = 67, 19%, 95% CI 15.6 to23.9), no statically significant difference in proportions (4.7, 95 CI ‐1.7 to 11.1). |
| Harutyunyan 2013 | ETS exposure: Adjusting for baseline hair nicotine concentration, child's age and gender, the follow‐up geometric mean hair nicotine concentration in the intervention group was 17% lower than the control group (P = 0.239). The GM of hair nicotine in the intervention group significantly decreased from 0.30 ng/mg to 0.23 ng/mg (P = 0.024), but not in the control group. Adjusted odds of children's less than daily exposure to SHS at follow‐up was 1.87 times higher in the intervention group than in the control group (P = 0.077). Air quality: According to mothers, 4.5% intervention households and 5.4% control households completely banned indoor smoking at follow‐up. Also 4.5% smokers in the intervention group and 0.9% in the control group have reportedly stopped smoking at follow‐up. Child health: N/A |
| Herbert 2011 | Recruited families to participate in the study through five public health nursing offices, eight daycare centres, and kindergartens on Prince Edward Island. Used a family‐centred assessment and intervention model to empower families to reduce cigarettes smoked in the home. Those identified as having children exposed to ETS were then invited to participate in group counselling sessions. Intervention: decrease from median of 17 to 4.5 cigarettes/day and Control: decrease from 18.5 to 3.5 cigarettes/day. Both decreases statistically significant so did not detect a beneficial effect of the intervention. At 6 months follow‐up intervention participants smoked 0.65 (95% CI ‐5.68 to 6.98) more cigarettes per day compared to control participants |
| Hovell 2000 | Reduction in parent‐reported child exposure to cigarettes in the home and in total. At home reported exposure Intervention baseline 3.9 CPD, follow up 0.52 CPD vs Control 3.51 CPD baseline, 1.20 CPD follow up. The trend for parent‐reported total CPD exposure was similar. Achieved a reduction in the number of parent‐reported cigarettes smoked in the presence of children per day at 12 months, following a three‐month intensive counselling intervention. There was, however, no change in cigarette smoke absorption as measured by children's urinary cotinine (ng/ml) for the intervention group over the 12 months (with measures collected at 3, 6 and 12 months). Cigarette smoke absorption for the control group increased from 9.4 ng/ml to 17.5 ng/ml over this time period, whereas there was almost no change in the intervention group (10.9 at baseline and 10.5 at 12 months). This increase in absorption observed for children in the control group appears to account for the apparent benefit of the intervention group. However the argument that this is solely due to reduced exposure in the home is uncertain, as the mothers in both the intervention and control groups reported falls in mothers' cigarettes smoked in the presence of the child from 3.9 to 0.5 (intervention) and 3.5 to 1.2 (control) cigarettes per day. In addition, they reported falls in total exposure to any source of cigarettes per day from 7.3 to 1.2 (intervention) and 7.2 to 2.8 (control). As the cotinine indicates a minimal fall for the intervention group and almost a doubling in urinary cotinine for the control group, either the cotinine measurement is unreliable or, more probably, that the parental report of cigarette exposure is not reliable. |
| Hovell 2002 | Latino families targeted. No significant effect. |
| Hovell 2009 | Low income households targeted. Behavioural ecological model used for development of the counselling intervention. Children's total SHSe showed a significant group by linear time interaction (P = 0.012) and a linear time effect (P < 0.001) from baseline to 6 months. Children's urinary cotinine showed no significant difference. Exposure from mothers in home (reported cigarettes/week) intervention 1.93 (95% CI 0.92 to3.48) control 6.16 (95% CI 3.61 to10.12); total reported exposure (cigarettes/week) intervention 5.15 (95% CI 2.71 to9.17) control 22.97 (95% CI 15.14 to34.58); mothers smoking reported cigarettes/week intervention 77.91 (95% CI 64.22 to91.60) control 92.88 (95% CI 80.59 to105.16); reported smoking by mothers indoors at home (cigarettes/week) intervention 3.94 (95% CI 2.06 to6.97) control 10.37 (95 CI 6.16 to17.06); reported smoking by all indoors at home (cigarettes/week) intervention 6.46 (95% CI 3.16 to12.40) control 19.18 (95% CI 11.15 to32.52). Children's urinary cotinine concentration and mother's reported smoking showed a significant group main effect, but did not show a significant difference in rates between intervention and control groups at 18 months. |
| Hughes 1991 | Intervention to reduce children's ETS exposure in a study of a comprehensive asthma education intervention. The outcome was improved asthma control but no change in exposure to ETS. |
| Irvine 1999 | No evidence of effect. |
| Joseph 2014 | ETS exposure: Little change in household or car rules about smoking 8 weeks after index visit, but parents reported a high rate of total restriction at baseline. Air quality: 8 weeks after index visit, 11 of 38 (29%) parents in the intervention group reported 7‐day point‐prevalent abstinence. In contrast, only one parent in the comparison group reported abstinence from smoking (P = 0.001). There were fewer quit attempts and less readiness to quit in the comparison group. Child health: Not reported |
| Kallio 2006 | At child 8 years of age 10.1% (29/287) of mothers and 19.7% (43/218) fathers in the intervention group smoked regularly. The corresponding %s for the control group were 15.1% (45/298) mothers and 25.1% (60/239) fathers. Additionally 5.9% (17/287) of intervention group mothers and 8.3% (18/218) of intervention group fathers smoked occasionally compared with 5.7% (17/298) of control group mothers and 6.7% (16/239) of control group fathers (NS). |
| Kegler 2015 | ETS exposure: Significantly more intervention participants reported a full ban on smoking in the home than control participants at both 3 months (30.4% vs 14.9%, P < 0.001) and 6 months (40.0% vs 25.4%, P = 0.002) post‐baseline. The longitudinal intent‐to‐treat analysis showed that the difference in change was significant over time. When defining success more stringently by including only those reporting a full ban and no enforcement challenges, we found again that more intervention than control participants were successful in having and enforcing their smoke‐free home rule at 3 months (11.0% vs 5.6%; P = 0.03) and at 6 months post baseline (18.3% vs 8.7%; P = ).002). Air quality: Larger reduction in self‐reported exposure to SHS in the home among intervention participants at both follow‐up points, with a significantly larger decrease in the intervention group. In addition, significantly higher percentage of intervention participants (26.2% vs 18.0%) reported a full smoking ban in cars at 3 months (P = 0.02), although this difference was not observed 6 months post baseline. Child health: Not reported |
| Kimata 2004 | After 1 month urinary cotinine levels reduced 285±43 ngmL‐1 to 2.2±0.85 ngmL‐1 in AEDS cessation group, 257±31 ngmL‐1 to 1.8±52 ngmL‐1 in normal child cessation group and 274±42 ngmL‐1 vs 298±52 ngmL‐1 in control group of children with AEDS. AEDS children showed significant reduction in SCORAD index skin wheal (mm) from 9.9 baseline to 7.5; Control group 9.6 baseline to 9.3. Also significant changes in response to house dust mite & cat dander & lower neutrophil levels. |
| Krieger 2005 | Intervention guided by the transtheoretical stages of change model, as well as by social cognitive theory. Report that 20% of the sample quit smoking and that among smokers who did not go outside to smoke prior to intervention, a quarter did so after education, but data are not provided and it is unclear whether intervention outcomes were different between groups. |
| McIntosh 1994 | Number of smokers who moved outside: Intervention 7/30, Control 4/30. Not statistically significant. |
| Nicholson 2015 | ETS exposure: At the end of the follow‐up phase, 45.4% of families reported a home ban (intervention: 47.2%; control: 43.6%) and 20.4% employed a full ban (intervention: 24.5%; control: 16.4%). Group assignment (intervention or control) was not a significant predictor of adopting a home ban. There was a marginal difference between intervention and control groups for the adoption of full bans (OR = 1.81, P = .060). Air quality: Not reported Child health: Not reported |
| Nuesslein 2006 | Calculated nicotine consumption Intervention: 12 micrograms to 4.65 micrograms vs Control: 12 micrograms to 7.5 micrograms NS |
| Ortega 2015 | ETS exposure: TSP‐avoidance strategies improved more in the intervention group than in the control: 35.4% and 26.9% (P = 0.006) at home, and 62.2% and 53.1% in cars (P = 0.008). Logistic regression showed adjusted ORs for appropriate measures in the intervention group vs control group of 1.59 (95% CI 1.21 to 2.09) at home and 1.30 (95% CI 0.97 to 1.75) in cars. Air quality: Not reported Child health: Not reported |
| Patel 2012 | No significant differences between intervention compared to control groups in: |
| Phillips 2012 | Where both saliva cotinine and self‐report were available, saliva cotinine was used. At eight weeks post‐partum, there was a significantly more smoke free mothers in the intervention (81%) compared with the control group (46%) ‐ P < 0.001. |
| Pollak 2015 | ETS exposure: Not reported Air quality: Found high rates of cessation but no arm differences in smoking rates at the end of pregnancy (0.31 vs. 0.30, materials only vs. counselling, respectively) and 12 months after randomisation (postpartum: 0.39 vs. 0.38). Found high quit rates among non daily smokers but no arm differences (0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum). Among daily smokers, found lower quit rates with no arm differences but effects favouring the intervention arm (0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum). Child health: Not reported |
| Prokhorov 2013 | Smoking status of smoker; 90% on baseline smokers in each group still using tobacco (N = 36 intervention, N = 35 control) Results for the environmental monitors: two monitors ‐ one in a "higher exposure" room than the other. In the high exposure room there was a significant main effect for time (P < 0.001) and time by condition effect (P < 0.05); for the intervention group the mean ambient nicotine level decreased from baseline at 12 months (1.14 μg/m3 to 0.20μg/m3, P < 0.01). There was a decrease in mean of control group but not significant (0.55 μg/m3 to 0.17μg/m3, P = .99), and a significant difference between average rate of change for intervention and control groups. In the low exposure there was a significant main effect for time but not time‐by‐condition and similar reductions in the intervention and control groups. Percentage of households banning smoking at 12 months: 73% of the intervention group and 56% of the control group. |
| Pulley 2002 | Follow‐up three weeks post‐intervention Cigarettes/day: intervention 16.17 (sd 9.10), control 11.33 (sd 4.69) ‐ P = 0.132 Mothers in the intervention group smoked more at enrolment compared with control group, an effect not present at the 2 week visit (baseline) but present again three weeks post intervention Respiratory illness: intervention N = 5 (42%), control N = 6 (66%) ‐ P = 0.666 |
| Ralston 2008 | Counselling strategies based on the stages of change component of Prochaska's transtheoretical model. N = 42, 33% (N = 14) lost to follow‐up. The quit rate: 14% intervention, 5% control group which did not reach statistical significance |
| Ralston 2013 | Differences between intervention and control groups were not significant (fisher's test): Self‐reported quit ‐ control 6/30 (20%, 95% CI 9 to 38%) and intervention 5/30 (17%, 95% CI 7 to 34%); any quit attempt during follow‐up ‐ control 11/30 (37%, 95 CI 22 to 55%) and intervention 16/30 (53%, 95% CI 36 to 70%); cut down ‐ control 11/30 (27%, 95% CI 22 to 55%) and intervention 15/30% (15%, 95 CI 33 to 67%); used quitline ‐ control 2/30 (7%, 95% CI 8 to 22%) and intervention 0/30 (0%, 95% CI 0 to 13%). |
| Ratner 2001 | 6 month Follow up: 36% abstinent, 26% occasional, 38% daily smoking. 76% homes smoke‐free. |
| Schonberger 2005 | At 6 month Follow up |
| Schuck 2014 | ETS exposure: Not reported Air quality: Parents who received quitline counselling were more likely to report 7‐day point‐prevalence abstinence at 12‐month assessment (34.0 versus 18.0%, odds ratio (OR) = 2.35, confidence interval (CI) = 1.56–3.54) than those who received a standard self‐help brochure. Parents who received quitline counselling were more likely to use nicotine replacement therapy (P < 0.001) than those who received a standard self‐help brochure. Among parents who did not achieve abstinence, those who received quitline counselling smoked fewer cigarettes at 3‐month (P < 0.001) and 12‐month assessment (P < 0.001), were more likely to make a quit attempt (P < 0.001), to achieve 24 hours’ abstinence (P < 0.001) and to implement a complete home smoking ban (P < 0.01). Child health: Not reported |
| Severson 1997 | Cessation at 6 & 12 months: Intervention 25/1073 (2.3%), Control 10/802 (1.2%), P < 0.05*, 1‐tailed test Only 35 of the 97 12‐month quitters had quit by six months, with more early quitters in the intervention group (25/59) compared with the control group (10/38). |
| Stotts 2012 | Lower rates of total smoking bans in the usual care‐reduced measurement group (P < 0.012 for total ban, P < 0.01 for car) but not significantly different for home alone. 63.6% receiving motivational interviewing had a ban by 1 month post‐discharged compared to 20% of the usual care group. No significant differences in environmental nicotine monitors measurements |
| Streja 2014 | ETS exposure: No significant difference between intervention and control groups in child urine cotinine levels. Air quality: No significant difference between intervention and control groups in any of the measures. Child health: Not reported |
| Tyc 2013 | Group difference for average cigarettes smoked and child SHSe was not significantly different as the 12‐month follow‐up (P > 0.05). Child SHSe was significantly lower at 12 months from baseline for each group (P < 0.05). Children's urinary cotinine showed no significant difference, and did not change significantly over time in either group. |
| Ulbricht 2014 | ETS exposure: The child urine cotinine level difference between follow‐up and baseline was smaller in the control than in the intervention group, but the effect was not significant. Air quality: Not reported Child health: Not reported |
| Van't Hof 2000 | There was no statistically significant difference in the smoking relapse rate between women in the intervention (41%) and control (37%) groups. |
| Vineis 1993 | Smoking cessation for mothers: Intervention 12/74 vs Control 10/84, OR 1.4, 95% CI 0.6 to 3.5 showed a trend towards smoking cessation for mothers classified as white collar workers in the intervention arm (5/33) versus the control arm (2/36) (Odds Ratio [OR] 3.0; 95% confidence intervals [CI] 0.6 to 16.0). No difference was detected for the other participants, comprising 80 blue collar mothers and a total of 411 men defined as white or blue collar workers. |
| Wahlgren 1997 | Intensive intervention was able to demonstrate a statistically significant but very small reduction in cigarette exposure from parents' cigarettes reported by parents without biological verification. Mean number of parent cigarettes smoked in presence of child fell in Intervention group: 5.8CPD baseline, 3.4CPD at clinic pre‐intervention to 1.2 CPD at 6 months following completion of intervention. In control group, parent reported exposure fell from 8.0 baseline, 5.7 pre‐intervention to 4.6 CPD at 6 month follow up. P for trend < 0.01. The effect size was small, however, and curiously, the largest fall in this measure occurred in the period after recruitment but before the intervention. After the intervention, parents reported a reduction of 1.1 cigarettes per day smoked in the presence of the children for the control group, and 2.2 cigarettes per day for the intervention group. There was no validation by measurement of children's exposure or absorption via cotinine, or validation of the parental reports, and the clinical significance of such a fall is unclear |
| Wakefield 2002 | Home smoking ban: |
| Walker 2015 | ETS exposure: No significant difference between group in urine cotinine level change over time, self‐reported SHS exposure, smoking ban, smoking cessation. Air quality: No significant change in smoking prevalence and intensity was seen by group. Child health: No significant difference in infant cough, acute respiratory illness or rate of hospitalisations between treatment groups. |
| Wang 2015 | ETS exposure: Children's urinary cotinine was significantly lower (Z = ‐3.136; P = 0.002) in the intervention group (1.29 ng/mL) than the control group (1.78 ng/mL). After 6months, reported mean ETS exposure from caregivers decreased 40.6% from baseline among the intervention group and 3.4% among controls. Air quality: Caregiver's 7‐day quit rate was significantly higher (34.4% versus 0%) (p < 0.001; adjusted OR = 1.13; 95% CI: 1.02‐1.26) in the intervention group. Child health: Not reported |
| Wiggins 2005 | Mothers living in disadvantaged inner city areas targeted. No significant effect of either intervention. |
| Wilson 2001 | Of 51 children with complete urinary cotinine: creatinine ratio (CCR) data. Log CCR (ng/mg) Intervention baseline 1.82, Follow up 1.27 vs Control baseline 2.34, Follow up 1.93, adjusted Diff ‐0.38, adjusted P = 0.26. examined the effect of an intervention targeting smoking behaviour change and asthma education on health care utilisation and asthma hospitalisations, and explored other measures of asthma control. It demonstrated a reduction in the prevalence of children making more than one acute care asthma visit in the year following the intervention. Given that there was no apparent benefit of the smoking‐related counselling on smoking‐related outcomes, it is likely that it was the asthma education that achieved the improvement in asthma morbidity, rather than the smoking behaviour programme. |
| Wilson 2011 | Mean urinary cotinine creatinine ratio (CCR) decreased in both groups (not shown data for 6 and 12 month follow‐up). The natural log of the urinary CCR decreased more in the intervention arm but it did not reach statistical significance (B coefficient ‐0.307 95% CI ‐0.633 to 0.018, P = 0.64) Decrease in asthma symptoms at follow‐up visits in both groups. The decrease in the intervention group did not reach statistical significance (B coefficient 0.035, 95% CI ‐0.208 to 0.277, P = 0.78) At 12 months 84.0% of the intervention group (N = 142) and 77.1% of the control group (N = 131) had home smoking bans (P = 0.11). |
| Winickoff 2010 | Prevalence of self‐reported 7 day abstinence 38% at baseline and 30% at follow up in the control group vs 31% at baseline and 30% at follow up in the intervention group (Effect size = 13% P = NS) Cotinine‐confirmed 7 day abstinence for baseline current smokers NS. |
| Woodward 1987 | No evidence of effect. |
| Yilmaz 2006 | Quit smoking: Child intervention group 24.3%; Mother intervention group 13%; Control 0.8%. (χ2 = 29.5, P < 0.0001) |
| Yucel 2014 | ETS exposure: No significant difference between intensive and minimal intervention groups in change in child urine cotinine levels. Air quality: No significant difference in any outcome. Child health: Not reported |
| Zakarian 2004 | Low income ethnically diverse population. Both groups showed significant decline in reported exposure to mother's cigarette's/week (intervention group 18.89 at baseline to 5.41 at 12 months, control group 13.25 at baseline to 5.23 at 12 months) (P < 0.001). Total exposure to cigarettes/week (intervention group 53.2 at baseline to 21.99 at 12 months, control 54.48 at baseline to 18.22 at 12 months) (P < 0.001) however, no significant difference between groups. |
| Zhang 1993 | This was a study designed to increase public knowledge of the health consequences of cigarette smoking and to promote healthier attitudes among elementary school students in China, and encouraged these students to help their fathers to quit smoking. Schools in one district used a tobacco control curriculum, and the control group were students in another district. The other school‐based study was a cardiovascular health promotion programme that included an intervention designed to limit children's ETS exposure and negative role modelling from staff and visitors smoking at school (Elder 1996). Conducted in the USA, this study used a cluster‐randomized design with schools as the unit of allocation.Number (proportion) of smoking fathers: Intervention baseline 6843/9953 (68.8%) & follow up 60.7% vs Control baseline 6274/9580 (65.5%), follow up "approximately the same" [numbers are not stated] |
Comparison 1 Results, Outcome 1 Main outcomes.
| Community‐based interventions for reducing children's exposure to environmental tobacco smoke (ETS) | ||||
| Patient or population: people who smoke and are involved in the care of young children (birth to 12 years of age) Settings: community Intervention: behavioural interventions Comparison: usual care or minimal intervention | ||||
| Intervention type and outcomes1 | Impact | No. of participants2 | Quality of the evidence | Comments |
| Multi‐component, counselling‐based interventions assessed with biochemical validation of ETS exposure and self‐report length of follow‐up: 3 to 12 months | Of 7 studies in this group, 3 found that the intervention group was significantly more likely than the control group to implement full home smoking bans. One study found that the geometric mean hair nicotine level in the intervention group significantly decreased from 0.30 ng/mg to 0.23 ng/mg (P = 0.024), but not in the control group. Four studies found no significant differences in the change in cotinine levels between intervention and control groups. | 2880 | +‐‐‐ VERY LOW3 | |
| Multi‐comoponent, education‐based interventions assessed with biochemical validation of ETS exposure length of follow‐up: 6 months | One study, with similar children’s urinary cotinine levels at baseline, found that cotinine levels were significantly lower (Z = ‐3.136; P = 0.002) in the intervention group (1.29 ng/mL) than in the control group (1.78 ng/mL) at 6 month follow‐up. The other study found no significant differences between intervention and control groups in child urine cotinine levels. | 307 | +‐‐‐ VERY LOW4 | |
| In‐person counselling (no additional components) assessed with biochemical validation of ETS exposure and self‐report length of follow‐up: 1 to 12 months | Of the 6 studies in this group, 3 found significantly greater reductions in cotinine levels in the intervention compared with the control group. Two studies found that the intervention group was significantly more likely to implement home smoking bans. Two studies found no significant intervention impacts. | 1001 | +‐‐‐ VERY LOW5 | |
| Telephone counselling assessed with biochemical validation of ETS exposure length of follow‐up: 9 months | One study found no significant difference in the proportion of children with low urinary cotinine levels (< 10 ng/mL) amongst parents receiving telephone counselling or a note regarding their child’s cotinine result. | 347 | ++‐‐ LOW6 | |
| ETS: environmental tobacco smoke | ||||
| 1 Not all studies reported length of follow‐up; length given based on those that reported. 2 Not all studies reported numbers of participants; number provided based on those that reported. 3 Downgraded two levels due to risk of bias: all studies at unclear or high risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 4 Downgraded one level due to risk of bias: one of two studies at high risk of bias. Downgraded two levels due to inconsistency: one study detected an effect and one did not; studies were clinically heterogeneous. 5 Downgraded two levels due to risk of bias: all studies at unclear or high risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 6 Downgraded one level due to risk of bias: one study at unclear risk of bias. Downgraded one level due to imprecision: only 186 participants with measured outcomes at nine‐month follow‐up. | ||||
| Interventions in the ill‐child setting for reducing children's exposure to environmental tobacco smoke (ETS) | ||||
| Patient or population: people who smoke and are involved in the care of young children (birth to 12 years of age) Settings: healthcare ‐ ill‐child setting Intervention: behavioural interventions Comparison: usual care or minimal intervention | ||||
| Intervention type and outcomes1 | Impact | No. of participants2 | Quality of the evidence | Comments |
| Multi‐component, counselling‐based interventions assessed with biochemical validation of ETS exposure and self‐report length of follow‐up: 5 to 12 months | Three studies found no significant differences between intervention and control groups. | 746 (3 studies) | +‐‐‐ VERY LOW3 | |
| Multi‐component, education‐based interventions assessed with biochemical validation of ETS exposure and self‐report length of follow‐up: 6 to 13 months | One study reported significantly lower child's ETS exposure at home by any smoker at 12 months' follow‐up (52% vs 58%; P = 0.03). Six studies found no significant differences between intervention and control groups. | 2936 (7 studies) | +‐‐‐ VERY LOW4 | |
| In‐person counselling (no additional components) assessed with biochemical validation of ETS exposure, self‐report length of follow‐up: 3 to 18 months | Eight studies appeared to show intervention benefits based on self‐reported ETS exposures but no significant differences between intervention and control groups in objective measures of exposure (e.g. cotinine). | 1835 (8 studies) | +‐‐‐ VERY LOW5 | |
| Telephone counselling | No studies examined telephone counselling delivered in the ill‐child setting and measured ETS exposure. | |||
| Brief interventions Assessed with presence of home and car smoking ban length of follow‐up: 24 weeks | One study showed no significant differences between intervention and control groups in changed smoking policy: OR 2.0 (95% CI 0.166 to 24.069). | 100 (1 study) | +‐‐‐ VERY LOW6 | |
| GRADE Working Group grades of evidence | ||||
| 1 Not all studies reported length of follow‐up; length given based on those that reported. 2 Not all studies reported numbers of participants; number provided based on those that reported. 3 Downgraded one level due to risk of bias: two studies at unclear risk of bias. Downgraded one level due to imprecision. Downgraded one level due to indirectness: all studies were set in the USA and cannot be generalised to low income countries where smoking is more prevalent. 4 Downgraded two levels due to risk of bias: five of seven studies at high or unclear risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 5 Downgraded two levels due to risk of bias: all eight studies at high or unclear risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 6 Downgraded two levels due to risk of bias: only study was at high risk of bias. Downgraded one level due to imprecision: small study with a small number of events and wide confidence interval. | ||||
| Interventions in the well‐child setting for reducing children's exposure to environmental tobacco smoke (ETS) | ||||
| Patient or population: people who smoke and are involved in the care of young children (birth to 12 years of age) Settings: health care ‐ well‐child setting Intervention: behavioural interventions Comparison: usual care or minimal intervention | ||||
| Intervention type and outcomes1 | Impact | No. of participants2 | Quality of the evidence | Comments |
| Multi‐component, counselling‐based interventions assessed with biochemical validation of ETS exposure, self‐report length of follow‐up: 2 to 12 months | One study found significant reduction in ETS exposure at home in the intervention group at age 6 years, but only on per‐protocol analysis (OR 0.71, 95% CI 0.59 to 0.87). One study found an increase in smoking bans in the home (19.3%) and in the car (7%) after 8 weeks' follow‐up in the intervention group, but not in the comparison group (2.5% increase in home ban and 0% change in car ban). One study found no significant difference between intervention and control groups in children’s urinary cotinine levels. | 8005 (3 studies) | +‐‐‐ VERY LOW3 | |
| Multi‐component, education‐based interventions assessed with biochemical validation of ETS exposure, self‐report length of follow‐up: 2 to 12 months | One study found that maternal self‐reported smoking at home around the infant was significantly less in the intervention group (8.6%) than in the control group (23.8%) (P < 0.05). Three studies found no evidence of effect of the intervention. | 1401 (4 studies) | ++‐‐ LOW4 | |
| In‐person counselling (no additional components) assessed with biochemical validation of ETS exposure, self‐report length of follow‐up: 3 to 90 months | One study found significantly greater reductions in geometric mean urinary cotinine in the intervention group (decrease from 48.72 ng/mg to 28.68 ng/mg) compared to the control group (decrease from 40.43 to 36.32 ng/mg). In addition, the intervention group had a significantly greater increase in the proportion of households with smoking bans at home (15% to 33.3%) compared to the control group (11.5% to 19.5%). One study found a significantly beneficial reduction in kitchen and TV room air nicotine levels in the intervention group than in the control group (P < 0.05). One study found no difference in serum cotinine concentrations between the intervention and control groups. | 1483 (3 studies) | ++‐‐ LOW5 | |
| Telephone counselling assessed with self‐report length of follow‐up: 6 months | One study found a greater proportion with partial home smoking bans in the intervention group (62.7%) than in the control group (56.4%), as well as a higher biochemically validated quit rate for the intervention group (10.6%) than for the control group (4.5%) at 6 months. | 952 (1 study) | ++‐‐ LOW6 | |
| Brief interventions assessed with self‐report length of follow‐up: not specified | One study found no significant difference in home (OR 1.04, 95 CI 0.47 to 2.28) or car smoking bans (OR 1.47, 95 CI 0.69 to 3.11) between intervention and control groups. | 218 (1 study) | +‐‐‐ VERY LOW7 | |
| CI: confidence interval; OR: odds ratio | ||||
| 1 Not all studies reported length of follow‐up; length given based on those that reported. 2 Not all studies reported numbers of participants; number provided based on those that reported. 3 Downgraded two levels due to risk of bias: all studies at unclear or high risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 4 Downgraded one level due to risk of bias: one study was at high risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 5 Downgraded one level due to risk of bias: two of three studies at unclear risk of bias. Downgraded one level due to inconsistency: interventions and populations were clinically heterogeneous. 6 Downgraded one level due to risk of bias: included study at unclear risk of bias. Downgraded one level due to indirectness: ETS exposure was measured indirectly as reported smoking restrictions in home. 7 Downgraded one level due to risk of bias: included study at unclear risk of bias. Downgraded one level due to indirectness: ETS exposure was measured indirectly as reported smoking restrictions in home and car. Downgraded one level due to imprecision: one study with a small number of participants and events. | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Main outcomes Show forest plot | Other data | No numeric data | ||
