Alcohol and Contraception Risk Reduction Internet Intervention to Prevent FASD

University Of Virginia, Charlottesville VA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): Fetal Alcohol Spectrum Disorders (FASDs), including Fetal Alcohol Syndrome, lead to enormous societal and financial costs. Fetal alcohol exposure can result in a range of outcomes from mild learning and social problems to tragic permanent damage to the child's face, brain, organs, and health. Alcohol-exposed pregnancy (AEP) has been defined as any pregnancy during which a woman drank any alcohol at any time, and can result in FASD. Primary prevention of AEP and its sequelae is possible if drinking women prevent unintended pregnancy, or if women intending pregnancy reduce or eliminate drinking. Efficacious interventions to reduce the risk of AEP have been developed, but are not widely available. In this project, we will develop a novel Internet intervention to reduce AEP risk by combining the resources of two research teams focused on primary prevention of FASD and robust Internet interventions, respectively. We will use our evidence- based AEP risk reduction intervention materials and our existing Internet intervention development platform to build and pilot test an Internet intervention (Contraception and Alcohol Risk Reduction Internet Intervention, CARRI) in a stage 1 behavioral and integrative therapies development project. This three year R34 project will develop and program the new Internet intervention, and will determine the feasibility and preliminary efficacy of the intervention in a pilot RCT. During the intervention development phase, we will adapt the evidence-based CHOICES intervention using expert consultants to inform the creation of an appealing program, obtain user input, modify the program to maximize feasibility, appeal, and impact, and then pilot test it with users at risk iteratively. Once the intervention is finalized, we will assess the feasibility and preliminary efficacy of CARRI against a Patient Education Website condition in a pilot RCT with assessments at pre-, post-, and 6 months. Participants in the pilot RCT will include 70 women who are at risk for AEP. Standard, reliable measures of predictors, covariates, process variables, and outcomes will be used. The primary outcome will be drinks per drinking day measured by the combination of prospective self-report diaries and the TLFB, with a secondary outcome of episodes of ineffective contraception. Analyses will address additional continuous outcome markers including number of binges, number of heavy drinking days, and number of protected sexual intercourse events, to be analyzed using repeated measures ANOVAs. In exploratory analyses, we will use our Model of Internet interventions to identify user characteristics, website use variables, and change mechanisms that predict AEP risk reduction. We will prepare for a future cost effectiveness evaluation in the larger RCT to follow by pilot testing proposed measures. The pilot RCT will yield effect size estimates for a subsequent fully powered trial. If the Internet intervention is promising, it should be tested in a fully powered national trial. The Internet intervention could substantially increase the options for AEP prevention, and could lead to a reduction in incident FASD.