Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial

This study focuses on a national priority, the prevention of drinking during pregnancy and Fetal Alcohol Spectrum Disorders (FASD). Prenatal alcohol use, a leading cause of preventable birth defects in the U.S., continues to be a public health problem. Delayed pregnancy recognition and stigmatization concerns related to disclosure of drinking hamper prevention efforts with pregnant women. Heavy drinking increases risk for unintended pregnancy and for prenatal drinking. Thus, high rates of heavy drinking and of unplanned pregnancies in women in the U.S. suggest the need for primary prevention with all women of childbearing age.  Screening and brief intervention (SBI) reduces drinking but remains underutilized due to resource limitations in public health care.  The impending implementation of the Affordable Care Act (ACA) in an economy with dwindling health care resources indicates an urgent need for low-cost tools for delivering SBI.  We will study a recently piloted, self-administered, computerized tool for reducing prenatal drinking that adds novel components of drink size assessment and drink size feedback to traditional SBI.  We will adapt this bilingual (English and Spanish) electronic SBI or “e-SBI” for use with non-pregnant women and conduct a small trial of its efficacy in a public health clinic. We will also study effects of drink size assessment by itself and if depression modifies e-SBI efficacy. Study findings will help design a larger trial of e-SBI’s efficacy for reducing prenatal alcohol use.

We will use an experimental design for the proposed small trial. We will randomly assign 150 women, who have not been pregnant in the past year and report drinking, to e-SBI or usual care.  We will complete baseline, 3-month and 6-month follow-up assessments, and examine drinking and pregnancy as primary outcomes, and health risks, i.e., drug use, sweetened beverage and depression as secondary outcomes. Secondary outcome data allow us to examine e-SBI’s potential negative effects and set our proposed study apart from prior e-SBI studies that did not examine possible SBI-related adverse outcomes, such as increased drug use.  To address methodological limitations in prior research, we will incorporate drink size assessment to better measure drinking outcomes, minimize assessment reactivity for controls at baseline, and include a booster e-SBI at the 3-month follow up. This allows us to examine whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI.  With these design innovations, our study will provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.