Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to lay the ground work for a fully powered clinical trial of a
      computer-delivered screener and intervention for alcohol use during pregnancy. The pilot
      study will include:

        1. Evaluation of the usefulness of handheld devices and anonymous screening for self report
           of at-risk alcohol use among pregnant women.

        2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the
           detection of at-risk drinking in pregnant women.

        3. Evaluation of the efficacy of a computer-delivered brief intervention and use of
           tailored handouts to supplement the computer-based brief intervention focusing on
           alcohol use during pregnancy.
    

Detailed description: 
      Infants born to African-American and/or low SES women appear to be at increased risk of
      adverse effects due to prenatal exposure to alcohol. Computer-delivered SBIRT approaches may
      provide consistent screening and evidence-based brief interventions, at low cost, without
      requiring substantial investments of time or energy from medical staff. However, several
      Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application
      will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered
      SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key
      preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and
      an anonymous self-interview format in screening for at-risk drinking among patients attending
      a prenatal clinic; (2) modification of an existing computer-delivered motivational
      intervention for alcohol use during pregnancy, to previously set standards of acceptability
      (to experts as well as representative pregnant women); (3) development of an evidence-based
      tailored messaging supplement to the single-session brief intervention; (4) examining the
      validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and
      (5) collecting data on the acceptability, feasibility, and estimated effect size of the
      modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial.
      Participants in this trial will be a diverse sample of women at-risk for alcohol use during
      pregnancy, the majority of whom will be African-American and/or low SES. These key
      preparatory steps will greatly facilitate the subsequent development of an R01 application to
      conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also
      provide important preliminary data on (a) a novel method for risk factor screening in primary
      care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in
      the perinatal period; and (c) the effect size estimate for a fully computer-delivered,
      combined brief interactive/tailored messaging intervention requiring only a single contact.
      If successful, this line of research could lead to a highly cost-effective, high-reach
      intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn
      have a meaningful population impact on Fetal Alcohol Spectrum Disorders.
    

Intervention name(s): Nutrition time control/placebo intervention; Computer-delivered, brief intervention on alcohol use
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.; A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: pregnancy; screening; motivation