BACKGROUND: 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. METHODS: 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, 9 weeks 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. RESULTS: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. CONCLUSIONS: These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT.
RCT Entities:
BACKGROUND: 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. METHODS: 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, 9 weeks 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. RESULTS: 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. CONCLUSIONS: These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT.
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