Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies. - Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders, adversely affecting physical, cognitive, motor, and neurodevelopmental delay. In a pilot study (N=318) conducted by our U.S.-Rusian team at the Irkutsk Regional Maternity Hospital (RMH), 59% of women tested positive for alcohol consumption as assessed by a laboratory-confirmed alcohol biomarker (PEth). The proposed study will adapt an effective alcohol reduction intervention evaluated in Russia among non-pregnant alcohol-using women to optimize its efficacy for alcohol-using women in prenatal care. We propose to implement a randomized controlled trial (N=720) to assess the efficacy of the alcohol reduction intervention, relative to standard-of-care, in (1) reducing alcohol consumption among pregnant women in prenatal care, 2) reducing poor birth outcomes, and 3) reducing infants’ alcohol-related physical and facial characteristics, and cognitive, motor and neurodevelopmental outcomes. We will recruit women at their first prenatal visit to the Irkutsk RMH. Eligible women (1) are >18 years; (2) provide informed consent; (3) have a positive rapid point-of-care urine test for recent alcohol use; and (4) ≤8 weeks gestation complete a baseline assessment. Women are randomized to one of two conditions: the intervention condition, which includes standard-of-care plus the alcohol reduction intervention, or the comparison condition, which provides standard-of-care only. In the alcohol reduction intervention, participants receive: (1) a computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction, and (2) a brief obstetrician-delivered component reinforcing the computer-delivered content. The alcohol reduction intervention is theory-driven and uses motivational enhancement strategies to promote alcohol reduction. The alcohol reduction intervention is delivered to women on three occasions, following their baseline, 2nd-trimester, and 3rd-trimester assessments. Women in the comparison condition complete assessments on the same schedule. To assess infant birth outcomes, we will abstract medical records shortly after delivery. To assess physical and facial characteristics and cognitive, motor, and neurodevelopmental outcomes, all mothers return with their infants to complete 6- and 12-month infant assessments. An intent-to-treat analysis evaluates the efficacy of the intervention condition relative to the comparison condition in enhancing the proportion of women detected with a laboratory-confirmed negative PEth test. Other analyses assess intervention effects on birth outcomes, infant physical and facial characteristics, and cognitive, motor, and developmental outcomes at 6- and 12-months. The proposed research is scientifically and clinically significant. If demonstrated effective, the intervention may represent a scalable alcohol reduction strategy for prenatal care in other maternity hospitals in Russia and elsewhere to reduce prenatal alcohol exposure and alcohol-related birth and infant developmental outcomes. If successful, this would be the first prevention intervention conducted as part of CIFASD.
