A Pilot RCT of an Internet Intervention to Reduce the Risk of Alcohol-Exposed Pregnancy.

Abstract

Preventing alcohol-exposed pregnancies (AEPs) could reduce the incidence of fetal alcohol spectrum disorders. Previous face-to-face interventions significantly reduced risk for AEP, but a scalable intervention is needed to reach more women at risk. This study compared a 6 Core automated, interactive, and tailored Internet intervention, the Contraception and Alcohol Risk Reduction Internet Intervention (CARRII), to a static patient education (PE) website for its effect on AEP risk. Participants were recruited online to a pilot randomized clinical trial (RCT) with baseline, 9weeks posttreatment, and 6-month (6-M) follow-up assessments. Seventy-one women completed online questionnaires and telephone interviews and were randomized to CARRII (n=36) or PE (n=35). Primary outcomes were rates of risky drinking, unprotected sex episodes, and AEP risk, collected from online prospective diaries. CARRII participants showed significant reductions in rate of unprotected sex from pretreatment (88.9%) to posttreatment (70.6%) (p<0.04) and to 6-M follow-up (51.5%) (p=0.001); rate of risky drinking from pretreatment (75.0%) to posttreatment (50.0%) (p<0.02), but insignificant change from pretreatment to 6-M follow-up (57.6%) (p<0.09); and rate of AEP risk from pretreatment (66.7%) to posttreatment (32.4%) (p=0.001) and to 6-M follow-up (30.3%) (p=0.005). PE participants demonstrated no significant changes on all 3 variables across all time points. Intent-to-treat group-by-time tests were not significant, but power was limited by missing diaries. Over 72% of CARRII participants completed all 6 Cores. Exploratory analyses suggest that higher program utilization is related to change. These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT.