Tuten 2012a.
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. |
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Interventions |
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). |
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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. |