Floyd 2007.

Methods	Design: individually randomized Location: Florida, Virginia, and Texas (USA) Time frame: recruited July 2002 through January 2004 Sample size calculation (and outcome of focus): N = 60 in each group to detect 30% difference in reduction of problem drinking
Participants	General with N: 830 women; age 18 to 44 years; at risk for alcohol‐exposed pregnancy Sources: primary care practices; jails; drug and alcohol treatment centers; hospital‐based gynecology clinic; Medicaid health maintenance organization; and media‐recruited sample Inclusion criteria: 18 to 44 years old; no condition causing infertility; not pregnant or planning to get pregnant in 9 months; had vaginal sex in past 3 months (or 3 months prior to jail) with non‐sterile male and without using effective contraception; engaged in risky drinking (≥ 5 drinks in a day or on average ≥ 8 drinks per week); available for follow‐up Exclusion criteria: no mention
Interventions	Study focus: change one or both of the target behaviors, i.e. risky drinking and ineffective contraceptive use Theory or model: motivational interviewing (MI) and Transtheoretical Model (TTM) Treatment: 4 MI counseling sessions and 1 contraceptive counseling visit (45 to 60 minutes each) Comparison or control: brochures on alcohol use and women's health in general Duration: 14 weeks with sessions 2 to 3 weeks apart
Outcomes	Primary: ineffective contraception use (vaginal sex without contraception or with ineffective contraception, i.e. reported deviation from published guidelines for method use) Secondary: NA Follow‐up assessments: 3, 6, and 9 months
Notes	2016 article by Parrish examined mechanisms of treatment effect
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Data coordinating center used randomization program to generate unique IDs for each site; equal number in each study group
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered, sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Presume no blinding of participants; not feasible due to type of intervention
Blinding of outcome assessment (detection bias)	Low risk	Follow‐up interviews conducted by staff blinded to group assignment
Outcome measures	High risk	Contraceptive use from self‐report
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up: 29% overall; 30% treatment and 27% control
Other bias	Unclear risk	Analysis for cluster randomized trial: NA