Yonkers 2012.
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. |
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Interventions | Women were randomized to one of two groups:
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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. |
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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. |
CBT = Cognitive behavioural therapy; MET = Motivational enhancement therapy; MI = Motivational interviewing; MMT = Methadone maintenance therapy; OB/Gyn = Obstetrical/gynecological;
BA = brief advice therapy.