Methods

RCT.
No difference between groups on baseline drug use or demographic characteristics.

Participants

20 pregnant women enrolled in methadone maintenance. Mean age 27.6; 78.6% non‐minority (11/14); 78.6% single; 100% unemployed; 8(± 6) weeks gestational age upon entry into MMT; 2.7 mean days cocaine use in past 30 days. Exclusion: > 28 weeks pregnant.

Interventions

Daily MMT, weekly group counselling, three times/week urine toxicology screening for all participants.

1. Weekly prenatal classes, weekly relapse‐prevention groups, childcare during treatment visits, and CM awards ‐ USD15/ week for three consecutive negative urine screens (n = 7).

2. MMT and weekly group counselling (n = 7).

No difference between groups in terms of MMT dose (mean 50 mg).
Duration: average 23 weeks (range 13 to 31 weeks).

Outcomes

Attendance was measured in terms of % number of groups attended. Infant outcomes measured as mean gestational age at delivery, mean weight, and mean number of days in the hospital. Urine toxicology was measure as % positive for cocaine, opiates, or other drugs.

Notes

Unable to measure retention as not reported. We attempted to contact trial authors but data was unavailable.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"a total of 20 women provided informed consent and were randomly enrolled…"

No details were provided related to randomization methods.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment was not described.

Incomplete outcome data (attrition bias)
All outcomes

High risk

"A total of 20 women provided informed consent and were randomly enrolled.  Of these, one delivered within 1 week of providing consent, one was hospitalized for sedative detoxification, and four, all of whom had been on the methadone programme for several months or years when they became pregnant, did not participate in any groups or study assessments and were considered dropouts."

20 patients randomized and only 14 analysed. 6 dropouts (unclear from which randomized groups). Exclusions in analysis were lost to follow‐up because they did not attend meetings or because of early labour. These are all possible outcomes of the review and their exclusion biases results. Also analysis was per protocol not ITT.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Participants

12 cocaine‐dependent pregnant women: 58% African American, 8% Hispanic, 33% White; 92% never married or separated/widowed/divorced; 75% high school; 83% unemployed; 67% gravida 5 or more, 25% gravida 3 to 4; 75% in second trimester; DSM‐III‐R: 92% (10/11) cocaine primary drug of abuse, 8% (1/11) both heroin and cocaine dependent.

Exclusion: Cessation of cocaine use greater than 30 days prior to enrolment.

Interventions

All received PNC, behaviourally‐based drug counselling, nutritional education, and HIV counselling.

1. CM, $18 for each cocaine‐free urine sample, $20 weekly bonus if all 3 samples negative and perfect attendance (including PNC) (n = 6).

2. Routine care. Duration unclear (at least 4 weeks) (n = 6).

Outcomes

Retention in treatment as number remaining in treatment. Abstinence as average of individual %. Attendance in PNC as number of visits. Perinatal outcomes as number of preterm labour, or preterm delivery, or both. ASI composite scores presented as a bar graph. All outcomes reported as chi square with P value only when significant.

Notes

Treatment facility provided free transportation and child care. We attempted to contact trial authors but received no response.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Following stratification on referral source (self vs. court or probation or parole), subjects were randomly assigned to one of two treatment groups…"

No details provided related to randomization methods.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition details outlined for the 12 women, all 12 carried throughout the analysis. Results have detailed participant numbers for each outcome.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Groups significantly different for race. No difference in drug use and psychiatric comorbidity.

Participants

77 pregnant opioid‐dependent women randomized with 14 disqualified post‐randomization, ≤ 26 weeks gestational age, receiving MMT and ≥5 cigarettes/day. Mean age 29.7; 84% African American; 79% single or never married; 97% unemployed; 94% less than high school education. DSM‐III‐R: all heroin dependent (100%), 41 (35%) cocaine dependent, 10 (16%) marijuana dependent, 17 (27%) alcohol dependent, all (100%) nicotine dependent.

Exclusion criteria: not stated.

Interventions

For all MMT, no information on urine monitoring, or counselling/therapy. All received USD 10 voucher after initial battery and USD20 when 10‐week interview completed. Mean MMT dose 65.2 mg. All received PNC and substance abuse counselling ‐ no details described.

1. Four MET sessions using a modification of the Project MATCH MET manual (Miller et al., 1995). Visit 1 ‐ rapport building; visit 2 (1 week later) ‐ personalized feedback on positive behaviours, negative consequences of smoking, and stage of change; visit 3 (week 4) ‐ commitment and plan for change developed; visit 4 (week 6) ‐ barriers to long‐term change addressed (n = 30 post disqualification).

2. Standard care advice (no specific details related to content provided) (n = 33 post disqualification).

Duration 10 weeks.

Outcomes

Retention in treatment as % attrition. Stage of change and stage movement. Urine toxicology done at the 10‐week follow‐up.

Notes

Randomization occurred during residential treatment.
14 disqualified post randomization for spontaneous abortion. 21 excluded for reasons not stated.
We received raw data for urine toxicology after contacting the trial authors for information.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Seven women refused study participation and 77 patients completed baseline assessment and were randomized".

No specific methods for randomization outlined.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not described.

Incomplete outcome data (attrition bias)
All outcomes

High risk

"At the 10‐week follow‐up, participant attrition was 14% (n = 9), with missing participants evenly distributed between the MET (n = 4) and SC (n = 5) groups. The only difference between completers and those lost at follow‐up was average methadone dose during treatment (M=50.8mg vs. 36.3 mg, respectively), t(61)=‐6.34,p<.0001."

Some information was provided related to attrition (total number of individuals who dropped out). Outcome measures did not explicitly state the number of participants analyses were based on. Furthermore, details were not provided related to which groups the initially disqualified participants came from, making attrition data more unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding of outcome assessors.

Methods

RCT.
No difference between groups on baseline drug use.

Participants

93 pregnant women enrolled in substance use treatment, 18 years of age or older, meeting DSM‐III‐R criteria. Average age 28.9; 88% African American; 75% single; 50% less than HS education; 97% unemployed; DSM‐III‐R: 75% cocaine dependence, 74% opiate dependence, 50% both; 25 women (27%) received MMT.

Exclusion criteria: not stated.

Interventions

For all participants, treatment services included a 7‐day residential stay followed by a 30‐day intensive treatment (7 days/week, 6.5 hours/day). For individuals receiving MMT, no information on doses.

1. 5$ incentives given out during the first 7 days of outpatient treatment (n = 53).

2. 0$ incentives given.

For MMT subgroup: could receive USD5 for each negative urine and USD25 or USD50 bonus for 5 or 7 days drug‐free urine, and additional USD20 if completed all urine samplings and or attendance card monitoring. For non MMT: USD5 each day attended at least 4 hours treatment, USD25 or USD50 bonus for attending 5 to 6 or 7 days. (n = 40)
Duration: 37 days.

Outcomes

Attendance was measured in days and hours. Urine toxicology was not reported. Retention or loss to follow‐up was not reported.

Notes

Transportation and childcare provided.
Although randomized to incentive vs. no incentive, the nature of the disbursement of the incentives varied between MMT and not MMT subgroups.
We contacted the trial author who was unable to provide original data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"On admission, both MM and AT subjects were recruited and randomly assigned to one of two incentive conditions…"

No explicit methods of randomization outlined.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not described.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No details related to attrition provided. No detailed results included, unclear which participant numbers outcomes are based on.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.
No difference between groups on baseline drug use or demographic characteristics.

Participants

80 pregnant women on MMT, greater than 18 years of age, meeting DSM‐II‐R criteria for opiate dependence with cocaine abuse, admitted for first time for substance abuse treatment. Mean age 28; mean gestational age 23.4; 96% unemployed; 85% single/never married; 76% African American; 20% chronic medical conditions (HTN, DM, HIV); DSM‐III‐R: 100% opiate dependent, 69% cocaine, 5% marijuana, 10% alcohol.

Interventions

For all participants treatment consisted of a 7‐day residential followed by 7 days of intensive outpatient (7 days/week, 6.5 hours/day). Treatment consisted of group counselling and at least once a week individual psychotherapy. All received MMT, mean dose 42.

1. Money vouchers could be earned for specific target behaviour: attend at least 4 hours counselling and (days 8‐14) provide a cocaine negative urine sample (n = 44).

2. No voucher incentives (n = 36).

Duration 14 days.

Outcomes

Attendance was measured as mean full day attendance as well as "perfect treatment attendance" defined as attendance on at least 13 or 14 full days of treatment. Retention was measured as the % drop out. Urine samples were collected daily from days 8 to 14 and reported as % positive.

Notes

Transportation, child care, on site PNC and psychiatric consultation provided.
We contacted the trial authors who were unable to provide raw data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization procedure involved patients selecting one of two different color chips from a hat with replacement following each selection…"

Specific process outlined that provides participants with equal chance of assignment.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment was not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition data specified and descriptions of different analytic methods to account for missing data outlined.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Participants

89 women at least 18 years old, with a single fetus, self‐reported heroin or cocaine use in the past 30 days, completion of a 7‐night inpatient stay on an assisted living unit and willingness to live in recovery housing or other drug‐free housing. 

Interventions

Both groups received usual care involving group and individual counseling and psychoeducation, medically‐assisted withdrawal for patients either refusing methadone maintenance or not meeting current opioid dependence criteria, methadone maintenance for qualifying opioid‐dependent patients, care management, obstetrical care, psychiatric evaluation and treatment, general medical management.

1. Reinforcement based treatment (RBT) included usual care as well as treatment planning, behaviour graphing, weekly recreational, vocational, and peer reinforcement groups (n = 47).

2. Usual care without any additional services (n = 42).

Outcomes

One month post‐randomization treatment outcomes included days retained in CAP treatment before delivery. Measures at baseline and 1 month after: number of days in recovery housing; heroin and cocaine use; employment status; illegal activity.  Maternal and neonatal outcomes at delivery: Maternal: enrolment at CAP at delivery; urine screening positive for any illegal drug at delivery. Neonatal outcomes: estimated gestational age at delivery; prematurity (< 37 weeks); birth weight, number of days of hospitalization after birth.

Notes

On‐site child care and paediatric care also provided to all participants.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"random assignment of participants to one of the two treatment conditions was performed by a staff member with no participant contact who generated a random condition assignment with a computer program…"

Type of computer programme is unknown, but was likely sufficient for randomization.

Allocation concealment (selection bias)

Low risk

"random assignment of participants to one of the two treatment conditions was performed by a staff member with no participant contact who generated a random condition assignment with a computer program…"
Staff member had no contact with participants.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

From caption of Figure 1: "All analyses reported in this paper are based on the data from these 89 participants and their respective 89 neonates".

Detailed attrition data with flowchart. 89 patients randomized and 89 patients data at follow‐up.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding of outcome assessors.

Methods

RCT.
No difference between groups in baseline drug use.

Participants

71 pregnant women who used illicit drugs in pregnancy, aged 18 years or older. (1) 35 (2) 36. Average age 27.1; 73% single/never married; 88% unemployed; 82% receiving government income; 32% African American, 50% Caucasian; DSM‐III‐R: 49% cocaine dependent, 28% marijuana, 4% alcohol.

Exclusion: no obvious impairment (acute psychosis or organic illness).

Interventions

For all participants, substance treatment counselling provided. Nature of counselling not elaborated.

1. 3 MI sessions (at the time of intake, 1 week following, and 2 months after completion). No manual was used. Session done by four mental health providers all with formal training in MI (n = 35).

2. Educational control group received 30 minute educational video at intake and at one week and 60 minute home‐visit at 2 months (n = 36).

Study duration 2 months.

Outcomes

Attendance reported as number and % attended. Urine was screened at intake and then randomly once per week and were reported as a mean proportion of negative screens.

Notes

Gender‐specific treatment centre. Transportation and childcare included.
Treatment integrity and MI proficiency were evaluated. Likert scores used to asses inter‐rater reliability.
We attempted to contact the trial authors but received no answer.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

We used a stratified random sample procedure based on ethnicity and drug of choice (cocaine/crack cocaine, marijuana, amphetamine/methamphetamine, alcohol, or PCP) to assign participants to conditions.

Comment: No specific descriptions of randomization methods were made.

Allocation concealment (selection bias)

Unclear risk

No references to allocation concealment procedures made.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Specific attrition data was not included. Some information related to number of sessions attended and no‐show rates for specific sessions were detailed, but overall study attrition was not outlined clearly.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of blinding of outcome assessors.

Methods

RCT.

Participants

92 pregnant women enrolled in MMT who injected drugs. Mean age 26.2; mean years education 10.2; 53% ever sex worker; mean gestational age 22 weeks; DSM‐III‐R: 85% opiate dependent, 15% cocaine, 59% marijuana, 32% alcohol, 98% nicotine.

Interventions

All participants received MMT (mean methadone dose 49 mg) and counselling about HIV risk.

1. 6 sessions of manual based CBT lasting 60 to 90 minutes, the first being more of a MI (n = 47).

2. No intervention (n = 45).

Duration 9 months.

Outcomes

Retention was measured as a proportion. Attendance was measured as the average number of missed appointments.

Notes

Researchers attempted to contact patients lost to follow‐up through the Department of Social Security and Department of Health.
We attempted to contact the trial authors but received no answer.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Study states that subjects were randomly allocated to the intervention or control group, but does not outline specific randomization methods.

Allocation concealment (selection bias)

Unclear risk

No specific references to allocation concealment methods were made.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

"Five subjects dropped out of the intervention condition; three before any sessions and four after two or more sessions. There were no differences in any of the variables (demographic, drug use or HIV‐risk taking behaviour) between those who remained in the study and those who dropped out. There were 40 subjects in each group at the post‐intervention assessment. Of these 80 subjects, 74 (92.5%) were contactable 9 months later.  One refused to participate further, giving a 91% follow‐up rate of those who complete pre‐ and post‐intervention assessments."

Attrition information provided, but differences between the intervention and control group not detailed.  In addition, specific participant numbers for different outcomes not stated.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Assessments occurred at pre‐intervention, post‐intervention and at 9‐month follow‐up.  Follow‐up assessments were conducted by an interviewer blind to the subject’s group membership."

Specific references to the blinding of the interviewer conducting follow‐up assessments makes the risk of detection bias low.

Methods

RCT.
Groups similar in terms of demographic and baseline drug use.

Participants

40 pregnant, unemployed, women 18 to 50 years old on MMT, and with positive urine toxicology for opiates within 6 weeks prior to enrolment. Mean age 32; 83% African America; 65% HS or greater education; 7.5% married; 100% unemployed; 100% used cocaine; 75% used cocaine.
Exclusion: at risk for suicide, psychiatric disorder.

Interventions

For all participants, substance abuse counselling and MMT provided. Details of counselling not given. No mention of MMT doses or schedule.

1. Therapeutic workplace 3 hours/day for 6 months. Job skills training provided. Base‐pay voucher given out at the end of shift. Entrance to workplace contingent upon negative urine sample. Job skills focused on data entry. Vouchers used to promote abstinence and maintain workplace attendance (n = 20).

2. "Routine" drug treatment services provided by the centre. Details not given (n = 20).

Duration 24 weeks.

Outcomes

Retention in treatment defined as remaining in the study through 24 weeks and reported as N and %. Urine toxicology reported as % negative over total study period for each group, and reported as overall positive and drug‐specific positive. Attendance in Therapeutic Workplace was calculated and presented in a bar graph for each woman.

Notes

Transportation and childcare provided at no cost.
We attempted to contact trial authors but received no answer.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"A modified dynamic balanced randomization was used to randomize patients sequentially to the treatment conditions."

Allocation concealment (selection bias)

Unclear risk

Allocation concealment was not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition details outlined, reasons for leaving also outlined. Different methods utilized to attempt to account for missing data.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Unable to assess baseline difference between groups as results reported in terms of MMT vs. not MMT.

Participants

142 pregnant women in a comprehensive substance abuse treatment programme, > 18 years of age, and who met DSM‐III‐R criteria for opiate or cocaine dependence, or both. Mean age 28.4; mean years of education 11; estimated gestational age 22 weeks; 53(70%) unemployed; 81.4% single/never married; DSM‐III‐R: 79.6% used cocaine; 83.8% used cocaine.
Exclusion: gestational age ≥ 34 weeks, psychiatric disorder, delivered, or had miscarriage during the study time.

Interventions

For all participants, treatment consisted of 7 days residential care followed by 30 days of day treatment (7 days/week, 6.5 hours/day). Group counselling with once/week individual counselling. Obstetrics/Gynecology services on site. For individuals on MMT, no mention of doses.

1. USD5 or USD10 incentives/day for at least 4 hours of attendance/day. (Not MMT n: 40, MMT not reported).

2. USD0 or USD1 incentives/day for at least 4 hour/day attendance. (Not MMT n: 36, MMT not reported).

Duration 30 days.

Outcomes

Retention in treatment defined as remaining in treatment for 30 days and reported as number of days. Mean number of days also calculated.

Notes

Results were not reported in terms of intervention vs. control group, rather in terms of MMT vs. not MMT. All individuals were randomized to USD0, USD1, USD5 or USD10 group, however USD0 and USD1 were grouped together as "control". Only USD5 and USD10 groups were analyzed as "intervention".
We attempted to contact the trial authors but received no answer.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Subjects were told that within 24 h prior to transfer from residential to IDT, they would be randomly assigned to one of the four incentive groups…"

No description of specific randomization process used.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not described.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Only breakdown of methadone vs. non‐methadone maintained provided, limited information related to incentive condition assigned. Presumably data is for all randomized individuals, given fact that retention and attendance are primary outcomes, unclear if this impacts outcomes.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Participants

91 pregnant drug‐dependent women enrolled in comprehensive drug use treatment programme ‐ 18 years of age or older who met the DSM‐III‐R criteria for opiate, or cocaine dependence, or both. 

Exclusion: Received methadone pharmacotherapy, delivered prematurely or aborted during study period, were administratively discharged from study, had extended or reduced residential stays, had acute psychiatric distress that prohibited study participation.

Mostly in early 30s, 74% single/never married, 84% African American, and 95% unemployed, mean education of 11.2 years (SD = 1.9).  79.0% cocaine dependence, 37.1% opiate dependence, 17.7% alcohol dependence, and 17.7% cannabis dependence.

Interventions

For all participants, treatment included 7 days of residential care followed by 30 days intensive outpatient care. 

1. Escalating voucher condition, also included an escalating voucher schedule for 14 days (starting at the first day of residential care). Participants had to attend a full day of counselling (4 hours) to earn a voucher. Initial incentive values were USD5 for Day 1 and increased USD5 per day for each consecutive day of treatment attendance up to USD70 for Day 14. Women could earn a maximum of USD525 for attending all 14 days of treatment. Participants were given one excused treatment day (n = 50).

2. Control: Routine care – 7 days residential followed by 30 days outpatient care (n = 41).

Outcomes

Rate of premature residential treatment dropout against medical advice (AMA).  Length of stay in treatment.  Mean days prior to AMA.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Those providing informed consent were randomly assigned to either standard care or an escalating voucher schedule.."

No specific description of randomization process used.

Allocation concealment (selection bias)

Unclear risk

No mention of allocation concealment.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

As attrition is a primary outcome, incomplete data does not seem to be an issue.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Blinding of outcome assessors not mentioned.

Methods

RCT.

Participants

222 pregnant women provided written consent, but 143 were randomized. Pregnant women with an estimated gestational age of < 28 weeks who were opioid dependent and methadone stabilized. Average of 30.0 years old (SD = 5.2), 71.4% African American, 69.9% never married, 11.6 (SD = 1.5) mean years of education, 6.0% currently employed.  

Exclusion: not receiving methadone maintenance, non‐compliant with study or CAP procedures, had a miscarriage or terminated the pregnancy, transferred programmes, or had a negative pregnancy test.

Interventions

1. Escalating reinforcement condition, earned a USD7.50 voucher for the first opioid negative and cocaine negative urine sample submitted. Voucher value increased by USD1/day on the specimen collection days until delivery or until the participant reached USD42.50 in earnings, after which earnings were capped and remained constant at this amount. If relapse occurred no reward for positive urine sample and value of voucher reset to USD7.50. Participants earned vouchers until delivery (n = 52).

2. Fixed reinforcement condition, participants received a USD25 voucher each time they provided a drug‐negative urine sample. Participants who remained drug abstinent through the incentive period had total potential earnings of USD950. Earnings continued if it occurred after week 13. A drug positive sample or missed urine sample precluded voucher earnings, but earnings resumed upon submission of next drug free sample (n = 38).

3. Attendance control condition, fixed and escalating participants were linked to an attendance control participant. Each time the fixed or escalating reinforcement participant received a voucher, the yoked participant received the same amount, regardless of urine test results for that individual. Control participants were not aware they were linked, but were told there was a chance that they might or might not be paid for delivering urine samples (n = 43).

Study duration was 13 weeks or until delivery with 1 week of inpatient treatment (when participants could earn two vouchers and 12 outpatient weeks during which participants could earn three vouchers weekly).

Outcomes

Drug abstinence (number of urine screening tests negative for both opiates and cocaine, number of negative urine tests prior to the first positive test and longest consecutive number of negative urine tests), opioid use (with similar parameters as drug abstinence), cocaine use (with similar parameters).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"participants were randomly assigned to one of the treatment conditions within 5 days of program admission…"

No specific description of randomization used.

Allocation concealment (selection bias)

Unclear risk

No mention of allocation concealment processes.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

"Ten cases were missing data on one or more of the concomitant variables so were dropped from the sample, reducing the final sample to 133 cases."

Some information about attrition given, but breakdown of assignment groups and attrition was not provided.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No mention of outcome assessor blinding.

Methods

RCT.

Participants

200 women participating in the pregnant women treatment programmes at the four participating community treatment programmes (CTPs).  At least 18 years of age and pregnant. Identified as needing substance use treatment via the CTP's usual screening procedure. Participants mostly unmarried, unemployed, and had, on average, high school education. Sample was fairly diverse in terms of race and ethnicity. Significant baseline differences between the intervention and control participants. Intervention condition had significantly older participants, significantly more minority participants, with significantly more years of education, and with significantly more participants with cocaine as their primary drug of choice (marijuana was primary drug of choice in the control group). Exclusion: not pregnant, did not need to enter substance abuse treatment, under 18, not interested in participating, had unstable living arrangements, had plans to relocate within 4 months, pending legal charges, required inpatient treatment, suicidal/homicidal risks, more than 32 weeks pregnant.

Interventions

1. Three‐session MET: rapport building, feelings discussion, reflective listening, affirmation; followed by reviewing participants individualized personal feedback report regarding consequences of substance use and pregnancy; lastly, developing change plan for participants who showed readiness and strengthening commitment for participants not yet ready (n = 102).

2. Treatment as usual (TAU) that is usually provided by the CTP (standard counselling sessions) (n = 98).

Active study phase was four weeks (three sessions of MET or TAU provided in the 28 day period).

Outcomes

Treatment utilization, defined as ratio of number of outpatient treatment hours attended to the number of hours scheduled. Number of weeks in which at least one treatment session was attended. Number of weeks until treatment dropout, dropout defined as failure to attend any treatment provided by the CTP for three consecutive weeks. Substance use measured by self‐report and qualitative toxicology results.

Notes

Participants in both conditions were encouraged to participate in other treatment services offered by the CTP (group treatment, case management).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Urn randomization to balance three dichotomous variables: pressure to attend treatment, self report of drug and alcohol use and need for methadone maintenance".

Unclear what type of urn randomization was used, but method likely adequate.

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition information provided (e.g. 200 randomized, 162 completed the 1‐month active phase) and statistical analyses related to attrition showed no difference between intervention and control group (P > 0.5).

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No references to outcome assessor blinding made.

Methods

RCT.

Participants

183 women attending two hospital‐based reproductive health clinics in Connecticut between June 2006 and July 2010.

Women met inclusion criteria if they: were aged > 16 years of age, were fluent in English or Spanish, had not yet completed 28 weeks of pregnancy at screening, were planning to deliver at a collaborating hospital, and using alcohol or an illicit drug other than opiates during the 28 days prior to screening or scored at least a "3" on the modified TWEAK survey.

Women were excluded if they: were already engaged in substance use treatment, endorsed nicotine or opiates as their only substance, had plans to relocate, were not willing to provide consent, were an imminent danger to themselves or their fetus, or if they required inpatient general medical or psychiatric treatment.

Interventions

Women were randomized to one of two groups:

1. Women received MET with CBT provided by a nurse‐ six sessions delivered in conjunction with prenatal and immediate postnatal care. Content included motivational enhancement, communication skills, functional analysis, safe sexual behaviour, relapse prevention, and problem‐solving skills. Each of the six sessions lasted approximately 30 minutes (n = 92).

2. Women received brief advice therapy (BA). BA involved brief counselling from an obstetrical provider‐ manualized version of standard interventions offered by obstetrical doctors and nurses. Counselling lasted about 1 minute and covered risks of substance use, importance of abstinence, and the benefit of seeking drug and alcohol treatment outside the prenatal setting (n = 91).

Outcomes

Outcomes were assessed as measured at intake, delivery, and 3 months post‐delivery.

The primary outcome was the percentage of days of any alcohol or drug use in the prior 28 days.

Secondary outcomes measured abstinence from substances (alcohol and drugs) according to self‐report, urine toxicology and combined self‐report and urine. Birth outcomes were also analyzed.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated block randomization used.

Allocation concealment (selection bias)

Low risk

A statistician or project member who had no direct contact with subjects maintained allocation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

ITT analysis not performed. Women were excluded from analysis if there were no follow‐up assessments and if there were early deliveries.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Urine toxicology used.