Contraception and Alcohol Risk Reduction Internet Intervention Randomized Trial
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

Summary: 
      The goal of the proposed research is to develop and pilot test a novel Internet intervention
      to reduce the risk of Alcohol-exposed pregnancy (AEP). 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 Fetal Alcohol Spectrum Disorders (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, CARRIII) 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. In
      this protocol, we will assess the feasibility and preliminary efficacy of CARRIII against a
      Patient Education Website condition in a pilot randomized clinical trial (RCT) with
      assessments at pre-, post-, and 6 months.The primary hypothesis is that women randomized to
      the CARRIII condition will change more in 3 markers of AEP-related outcomes (risky drinking,
      ineffective contraception, and AEP risk) than women assigned to the Patient Education website
      condition. 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.
    

Detailed description: 
      As the first study of a fully interactive Internet intervention for reducing AEP risk, the
      proposed project is a significant extension of the growing literature on Internet
      interventions to reduce problem drinking, which established their feasibility and
      acceptability, with evidence of efficacy especially in the university drinking setting. Most
      brief online interventions for problem drinking have incorporated self-assessment and
      tailored normative feedback, and some offer cognitive behavioral exercises. Only one
      web-based intervention to date targeted AEP risk. In that study, a static Internet
      presentation of AEP risk reduction intervention materials was compared to the same
      intervention delivered by mail in a quasi-experimental design. The web delivered and mailed
      versions of this self-guided change intervention significantly reduced AEP risk. The proposed
      intervention will build on this study as well as existing alcohol Internet intervention
      findings and extend the focus to a new population with a new goal (AEP prevention) by
      targeting both drinking AND ineffective contraception. It will also incorporate significant
      enhancements compared to the static web-based self-guided change intervention for AEP by
      adding dynamic, interactive, and feedback elements that mirror the interaction in successful
      face-to-face interventions.
    

Intervention name(s): CARRII; CARRII Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age.; CARRII Education provides information on women's health related to drinking and contraception in a static website format.
Other intervention name(s): Patient Ed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AEP, drinking, contraception, FASD, Internet interventions