Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies
New York University
Summary
The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.
Description
Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders (FASD). To address this health threat, researchers at New York University (NYU), the University of Texas Health Science Center-Houston, Purdue University, Health Resources in Action and the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) will develop, implement, and evaluate an alcohol intervention for women in prenatal care. This study is a randomized controlled trial (N=600) to assess the efficacy of an alcohol intervention, relative to usual prenatal care only, in reducing (1) women…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 18 years and above * Gestational age is 28 weeks or less * Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days Exclusion Criteria: * Under 18 years of age * Not pregnant or gestational age over 28 weeks * No recent alcohol use as assessed by self-report
Interventions
- BehavioralIntervention condition, the usual prenatal care plus the alcohol intervention
The intervention is theory-driven, based on Motivational Enhancement Theory (MET), and uses motivational strategies to promote alcohol reduction.
Location
- The University of Texas Health Science Center, HoustonHouston, Texas