Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies Supplement

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Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders (FASD). To address this 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 controlled trial (N=600) to assess the efficacy of the alcohol intervention, relative to usual prenatal care only, in reducing (1) women’s alcohol use and 2) poor infant birth outcomes. We will 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 (EtG) urine test for recent alcohol use 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 (PRN) consisting of an ACASI and collection of bloodspots for PEth analysis to assess alcohol consumption biologically. Subsequently, women are randomized to either (1) the intervention condition, the usual prenatal plus the alcohol intervention, or (2) the comparison condition, usual prenatal care only. Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks. The alcohol intervention consists of (1) a self-paced computer- delivered component to enhance knowledge, norms, and motivation for alcohol reduction and (2) a PRN- 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. The alcohol intervention is developed with guidance from multiple sources, including (1) the project’s Women’s Advisory Board; recruited from the proposed recruitment clinics who self-report alcohol use during pregnancy, and (2) project investigators and consultants with extensive experience and expertise in research and trial design, and developing and implementing SBIRTs for reducing alcohol use and other drugs among women, including pregnant women. The alcohol intervention is delivered on three occasions: (1) following the baseline and the 2nd- and 3rd-trimester assessments. Women randomized to receive usual prenatal care only complete assessments on the same schedule as women in the intervention condition. We will 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) increasing the proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy and (2) reducing the proportion of adverse birth outcomes among infants. The proposed research is scientifically and clinically significant. If demonstrated effective, the intervention may represent a scalable alcohol reduction strategy suitable for prenatal clinical care in other maternity hospitals and clinical sites to reduce prenatal alcohol exposure and adverse birth outcomes. If successful, this would be the first prevention intervention for CIFASD.