Psychosocial interventions for women enrolled in alcohol treatment during pregnancy.
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
This review will examine all randomised controlled trials which determine the effectiveness of psychosocial interventions in pregnant women who are enrolled in alcohol treatment programmes when compared to other psychosocial interventions, placebo, non‐intervention, pharmacological treatment and pharmacological treatment in association with psychosocial treatment on improving birth and neonatal outcomes as well as maternal and neonatal alcohol abstinence and on treatment retention and alcohol reduction.
Background
The use of alcohol during pregnancy is a common practice (Doggett 2006). In the US, 12% of pregnant women reported recent use of alcohol (NHSDA 2000). 75% of pregnant women in Australia reported alcohol use in the last twelve months (Higgins 2000). In the UK, 61% of mothers continued to drink alcohol while they were pregnant. The majority (71%) of those who continued to drink consumed less than 1 unit of alcohol per week and only 3% had drunk more than 7 units a week (ONS 2006). However, these figures are related to 'regular' use of alcohol and therefore are not necessarily at levels where there is evidence of associated harm. Alcohol misuse as defined by Midwives Information Resource Service (MIDIRS) is drinking more than one or two units of alchol a week (MIDIRS 2002).
There is no conclusive evidence that occassional or light alcohol consumption has any adverse effects on the growth or infact development (Taylor 1999;Taylor 2006). However, excessive alcohol use of alcohol during pregancy has been associated with increased risk of miscarriage, a reduction in foetal growth and imparied neurodevelopment (AAP 2000; Taylor 2006). Along with these detrimental effects to both the mother's and the baby's health there are innumerable costs to the economy. Alcohol misuse is estimated to cost the economy in the region of £20 billion (Strategy Unit 2003). In developed countries, alcohol is the third leading cause of ill health after smoking and raised blood pressure. Current estimates are that for one pound spent on effective substance use treatment, five pounds is saved in health and social care costs (Raistrick 2006).
Alcohol use during pregnancy is associated with a wide range of adverse effects both on the mother's health and her baby's. Alcohol is associated with a continuum of birth damage, which can be very serious (Barrison 1985). These effects can include a combination of developmental delay, growth retardation, neurological abnormalities and characteristic facial dysmorphology referred to as the Foetal Alcohol Syndrome (FAS). Adolescents and adults with FAS have varying degrees of psychosocial and behavioural problems (Weintraub 1998). Less severe effects of alcohol use during pregnancy include mild to moderate mental and physical growth retardation, referred to as Foetal Alcohol Effects (FAE) (Sanchez 1979).
Alcohol consumption during pregnancy has a vast impact on society and is the most commonly recognised cause of mental retardation, with as many as 5% of all congenital anomalies being attributed to prenatal alcohol exposure (Pietrantoni 1991). Children can also be at risk of reduced developmental goal attainment as a result of either a direct effect of alcohol use or from the associated lifestyle factors connected to alcohol use (Belcher 1999; Eriksson 2000; Faden 2000; Frank 2001; Jacobson 2002; Singer 2002). Increased child abuse and neglect has been documented in some populations, as a result of alcohol use during pregnancy (Besinger 1999; Nair 1997), along with child deaths (Jaudes 1997). Other major factors which are compromised by alcohol use during pregnancy include the mother‐infant attachment and responsiveness, along with post‐natal depression and possible domestic violence within the household. Mothers also tend to be less likely to attend health facilities for education, medical treatment and social support (Doggett 2006).
Specific interventions need to be put in place to assist pregnant women who have alcohol problems. Interventions should be aimed at harmful alcohol use, pregnancy care, health surveillance and promotion, counselling, social support, education, facilitation of mother‐infant interaction and promotion of parenting (Doggett 2006). The purpose of this is to facilitate earlier and more intensive pregnancy care, improve pregnancy and neonatal outcomes, reduce alcohol use, aid the mother‐infant interaction and improve the home environment. This should then improve longer‐term outcomes such as reducing child neglect, reducing mother‐infant separation, improving neurodevelopmental outcomes, increasing successful schooling performance and decreasing problems in adolescence and young adulthood (Olds 2002).
Specific interventions should ultimately be able to link the patient into the appropriate alcohol services, provide pregnancy care including monitoring and treating infections, provide nutritional advice and support, recognise pregnancy complications such as preterm labour, facilitate the appropriate delivery care, monitor the mother's and the baby's health and facilitate their interaction with one another. The goal of intervening should also be to monitor the families' compliance with standards of parenting care and also to ensure the infant's welfare.
Therefore, this review is focused on pregnant women who have an alcohol problem and who have been enrolled in alcohol treatment programmes, and not those who use alcohol occasionally or lightly. The types of psychosocial interventions included are contingency management, motivational interviewing, psychotherapy and behavioral therapy.
A systematic review is necessary in this area as, to our knowledge, there are none to date.
Objectives
This review will examine all randomised controlled trials which determine the effectiveness of psychosocial interventions in pregnant women who are enrolled in alcohol treatment programmes when compared to other psychosocial interventions, placebo, non‐intervention, pharmacological treatment and pharmacological treatment in association with psychosocial treatment on improving birth and neonatal outcomes as well as maternal and neonatal alcohol abstinence and on treatment retention and alcohol reduction.
Methods
Criteria for considering studies for this review
Types of studies
We will review all randomised controlled trials (RCTs) or quasi randomised controlled trials.
Types of participants
Trials that enrolled pregnant or postpartum women in alcohol treatment programmes will be included in this review. Studies will be excluded if the participants are illicit drug (i.e. cannabis, heroin, cocaine, amphetamine etc) as long as alcohol use is reported. Studies that did not report participants' alcohol use will not be included. There will be no age restriction, as long as the trial enrols pregnant women, it will be included. Both inpatient and outpatient or combination of inpatient and outpatient treatment will be included.
Types of interventions
Experimental intervention:
This review will include any psychosocial interventions that are validated or described by the study's author. The types of psychosocial interventions included are contingency management, motivational interviewing, psychotherapy and behavioural therapy. Combined psychosocial interventions will be included in this review. In order to be eligible, a study must include at least one group where only some psychosocial intervention will be given.
Control Intervention:
This review will compare the experimental intervention to: other psychosocial treatment, placebo, non‐intervention, pharmacological treatment and pharmacological treatment in association with psychosocial treatment.
Types of outcome measures
Primary outcomes
(1) retention,
(2) abstinence
Secondary outcomes
(3) birth weight
(4) gestational age at birth
(5) placental abruption
(6) foetal alcohol syndrome (FAS)
(7) admission to and length of time spent in hospital (i.e. neonatal intensive care unit [NICU])
(8) alcohol abuse measured by maternal toxicology, maternal self‐report, newborn toxicology and any biological markers provided in the original studies
(9) .treatment attendance as measured by the proportion or count of treatment visits attended
(10) treatment attendance as measured by the proportion or count of individuals who complete treatment
(11) prenatal care attendance as measured by the proportion or count of prenatal visit attended
Search methods for identification of studies
Electronic searches:
We will search the following databases:
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Cochrane Drug and Alcohol Group trials register (April 2007)
-
MEDLINE (1950 to April 2007)
-
PsycINFO (1806 to April 2007)
-
EMBASE (1974 to April 2007)
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CINAHL (1982 to April 2007)
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SPECTR (April 2007)
The searches will be based on the following MEDLINE strategy (Host: Dialog DataStar) with MESH terms and free text, adapted as appropriate to the specifications of each database.
Search strategy to locate drug / alcohol abuse:
1. Substance‐related disorders.de.
2. (Drug or substance) adj (Addict$ or abus$ or dependen$) ti, ab, de.
3. Alcoholism #.w.de.
4. (Alcohol adj abuse).ti, ab, de.
5. (intoxicat$ or abstinen$ or withdrawa$).ti, ab, de.
6. (Excessive$ adj use$) ti, ab, de.
7. (Use$ adj disorder$) ti, ab, de.
8. (Drinking adj behaviour)
9. Drinking behaviour.de.
10. Alcohol$.ti,ab,de.
11. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10
Search strategy for psychosocial interventions:
12. (Attendance adj incentive$). ti, ab.
13. Incentive$.ti, ab.
14. Voucher$.ti, ab.
15. Psychotherap$.ti,ab
16. Psychotherapy #.de.
17. (Behaviour adj therapy)
18. Behaviour therapy #.de.
19. Reinforcement #. w.de.
20. Reinforcement.ti, ab.
21. Motivation.ti,ab
22. Motivation #. w.de.
23. (Motivational adj interview$)
24. (Contingency adj management) ti, ab.
25. Counsel$ ti,ab.
26. (Cognitive adj therap$) ti,ab.
27. (Famil$ adj therap$) ti,ab.
28. 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27
Search strategy for pregnant women
29. Pregnancy #.w.de.
30. Pregnan$ ti, ab.
31. Pregnancy ‐complications.de.
32. Pregnancy‐complications ti,ab.
33. Infant‐newborn.de.
34. Postpartum‐period #.de.
35. Prenatal‐diagnosis #.de.
36. Fetus #.w.de.
37. 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36
Search strategy for trials
38. Randomised controlled trial.de.
39. PT‐ randomised controlled trial
40. PT‐control trial
41. Random allocation.de.
42. Double blind method. de.
43. Single blind method. de.
44. 38 or 39 or 40 or 41 or 42 or 43
45. PT‐ clinical trial
46. (Clin$ adj trial)
47. Clinical trial .de.
48. ((singl$ or doubl$ or trebl$) adj (blind or mask$)) ti,ab.
49. Placebo #.w. de.
50. Placebo$ ti, ab.
51. Random$. ti, ab.
52. Research design.de.
53. 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52
54. 44 or 53
55. and 28 and 37 and 54
The search strategy will be developed in conjunction with a librarian. We will not apply any language restriction to the review.
Additional searches
We will search:
1. the reference lists of all relevant papers to identify further studies.
2. some of the main electronic sources of ongoing trials (National Research Register, meta‐register of Controlled Trials; Clinical Trials.govs).
3. conference proceedings likely to contain trials relevant to the review.
We will contact investigators, experts in the field, seeking information about unpublished or incomplete trials.
Unpublished reports, abstract and reports will be considered for inclusion on the same basis as published reports.There will be no restrictions based on language or date.
Data collection and analysis
(1) Study selection:
Two reviewers will read all titles and/or abstracts resulting from the search process and eliminate any irrelevant studies. We will obtain full copies of all the potentially relevant studies. Two reviewers acting independently will classify these as include, exclude or unclear. Decision will be based upon inclusion criteria outlined in the protocol. Differences in opinion will be resolved through consensus or referral to a third reviewer.
(2) Assessment of the methodological quality:
Two reviewers will independently assess potential studies. Keys variables of methodological quality will be considered as follows.
The reviewers will asses the studies as per the Cochrane Collaboration Handbook. Appraisal of the included studies will be carried out independently by two reviewers. Any differences will be negotiated by a third reviewer to reach consensus. We will evaluate the methodological quality of the studies for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow‐up rates based on the criteria described below.
Selection bias:
Empirical research has shown that lack of adequate allocation concealment is associated with bias. Iindeed, concealment has been found to be most important in preventing bias than other components of allocation, such as the generation of the allocation sequence.
Performance bias:
Systematic differences in the care provided to the participants in the comparison groups and the placebo effect could take place in the addiction field. Blinding of providers avoids co intervention and ascertainment bias whereas blinding of participants avoids contamination, systematic differences in compliance, systematic differences in the placebo effect and detection bias.
Attrition bias:
Loss to follow up and drop out from the study is one of the major problem in the field of addiction. Retention in treatment is very often the primary outcome measure in these trials; for this reason the information on people who left the study will not be used as a validity criterion.
Detection bias :
To keep blind the people who will assess outcomes is particularly important when subjective outcome measures are used.
Selection bias, performance bias and detection bias will be assessed and rated as follow:
Selection bias: allocation concealment
A: Adequate allocation concealment: central randomization(e.g. allocation by a central office unaware of subject characteristics), pre‐numbered or coded identical bottles or containers which are administered serially to participants, drug prepared by the pharmacy, serially numbered, opaque, sealed envelopes, on‐site computer system combined with allocations kept in a locked unreadable; computer file that can be accessed only after the characteristics of an enrolled participant have been entered or other description that contained elements convincing of concealment.;
B: Unclear allocation concealment: when the authors either did not report an allocation concealment approach at all or report an approach that did not fall in the category A or C.
C: Inadequate allocation concealment: alternation or reference to case numbers, dates of birth, day of the week. Any procedure that is entirely transparent before allocation, such as an open list of random numbers or other description that contained elements convincing of not concealment
Consideration will be given to whether allocation to treatment group was concealed so that participants and investigators were unable to influence treatment provided.
Performance bias: blinding of those providing and receiving the intervention
A: double blind
B: single blind (blinding of participants)
C: unclear
D: no blinding
Detection bias: blinding of the outcome assessor
A) Blind to treatment allocation at outcome assessment
B) Unclear
C) Not blind to treatment allocation at outcome assessment
Intention to treat analysis will be considered:
A) Intention to treat analysis performed
B) Intention to treat analysis not performed
C) Unclear
The methodological assessments will not be used as inclusion criteria for the review, but will be described and discussed. Sensitivity analysis will be used to assess the methodolgical quality of the results.
(3) Data extraction
Data will be extracted by two reviewers independently using a data‐extraction form that will be developed to assess the following data: study location, methods, participant details, type of intervention, and outcome. One reviewer will enter data into RevMan 4.2., and a second will confirm correct data entry.
(4) Data synthesis
Meta‐analysis and narrative review will be performed where appropriate for each of the nominated outcomes. Where possible, we will pool results of similar stuides. Peto odds ratios with 95% confidence intervals will be used for dichotomous outcomes such as abstinence. Continuous outcomes will be analysed calculating the weighted mean differences (WMD) or the standardized mean differences (SMD) with 95% confidence intervals.
(5) Statistical analysis
The RevMan software package will be used to perform the meta‐analysis for continuous and dichotomous outcome measures. The outcomes from the individual trials will be combined through meta‐analysis where possible (comparability of intervention and outcomes between trials) using a fix effect model unless there will be significant heterogenity, in which a random effect model will be used. A P‐value of the Chi‐square test less than 0.05 indicates a significant heterogeneity. Due to the nature of the studies in this review, it is anticipated that there will be some degree of heterogeneity in the study interventions, outcome measures reported and methodological quality therefore it may not be appropriate to combine these studies.
