The purpose of this Stage 1 b behavior therapy development project is to develop and test the feasibility and promise of a brief, theory-based intervention to reduce the risk of alcohol-exposed pregnancy (AEP) in high-risk community women. During Phase 1, the investigators will adapt a promising intervention to a single extended session model, then pre-pilot test the intervention with 9 participants, iteratively revising the treatment manual. In addition, therapist adherence and competence rating forms will be developed and refined. During Phase 2, therapists and raters of process measures will be trained. During Phase 3, the team will implement a two-arm randomized controlled trial. Group 1 will receive the EARLY intervention, and Group 2, the comparison group, will receive an information/ attention intervention. The EARLY intervention, based on social learning theory and the Transtheoretical model of change, uses the motivational interviewing counseling style, and includes personalized feedback of risks related to drinking and ineffective contraception, information, decisional balance exercises, discussion of readiness to change, eliciting of goal statements, and development of change plans. Participants will be a high-risk community sample of 152 fertile women who drink frequently or who binge, and who use contraception ineffectively, drawn from STD and public health clinics and alcohol/drug treatment settings. Participants will complete a baseline assessment battery measuring demographics, alcohol and drug use, obstetrical/gynecological history, emotional distress, stages and processes of change, self-efficacy, and personality. Participants and therapists will provide process ratings of the behavioral intervention sessions. Quality assurance will be achieved through continuous supervision. Independent raters will rate therapist adherence to the protocol and competence in delivering the intervention. Follow-up assessments are at 3 and 6 months. Primary outcomes will be measured by a 90-day timeline follow-back for drinking and sexual activity/ contraceptive behavior. Because change in either risk behavior will lead to a reduction of AEP risk, three primary outcomes will be evaluated. These are the proportion of women no longer at risk for AEP at 6-month followup, the proportion of women no longer classified as risky drinkers, and the proportion of women no longer classified as ineffective users of contraception. Secondary analyses will identify correlates of change, including alcohol severity, drug use and severity, psychiatric co-morbidity, motivation for change, personality, and self-efficacy, and will examine mediator and moderator models of AEP risk reduction. During Phase 4, products needed to prepare for a larger Stage 2 efficacy trial will be developed. The long-term goal is to identify briefer interventions that effectively reduce the risk behaviors for AEP that could be transferred to a variety of public health treatment and intervention settings.
NIH ExPorter
NIH ExPorter