Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies.

Prenatal alcohol exposure increases the risk for Fetal Alcohol Spectrum Disorders. To address this public health threat, we propose an exciting collaboration between researchers at NYU, the University of Texas Health Science Center-Houston, Purdue University, and CIFASD to develop, implement, and evaluate an alcohol intervention for women in prenatal care. We propose a randomized trial (N=600) to assess the efficacy of an alcohol intervention, relative to usual prenatal care, in reducing (1) women’s alcohol use, and (2) poor infant birth outcomes. We recruit women at their first prenatal care visit. Eligibility criteria include (1) age ≥18 years; (2) ≤8 weeks gestation; (3) a positive rapid point-of-care ethyl glucuronide test or self-reported alcohol use in the prior three weeks; and (4) written informed consent. Eligible women complete a baseline assessment by a Project Research Nurse consisting of a self-paced audio-computer-assisted interview and provide bloodspots to biologically assess alcohol use. Next, women are randomized to (1) the intervention condition, usual prenatal care plus the alcohol intervention, or (2) the comparison condition, usual prenatal care only. Usual prenatal care involves clinicians assessing alcohol use and counseling women on alcohol-related risks. The alcohol intervention consists of (1) a self-paced computer-delivered module to enhance knowledge, norms, and motivation for alcohol reduction, and (2) a nurse-delivered module that reinforces the computer-delivered content and addresses women’s specific questions. Both components are theory-driven, based on Motivational Enhancement Theory, and use motivational strategies to promote alcohol reduction. The intervention is developed with guidance from multiple sources, including (1) the project’s Women’s Advisory Board, consisting of women who received prenatal care at participating clinics, and (2) project investigators and consultants with extensive experience in developing and implementing interventions to reduce alcohol and other drug use among women, including pregnant women. The intervention is delivered on 3 occasions, following the baseline, 2nd- and 3rd-trimester assessments. Women in the comparison condition complete assessments on the same schedule as the intervention condition. We use generalized estimating equation models and an intent-to-treat analysis to evaluate the efficacy of the intervention condition, relative to the usual prenatal care condition, in (1) reducing the proportion of women with a laboratory-confirmed positive blood test for alcohol, and (2) reducing the proportion of adverse birth outcomes among infants.