U01AA030187

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.-Russian 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.

New York University

TO DEVELOP A SOUND FUNDAMENTAL KNOWLEDGE BASE WHICH CAN BE APPLIED TO THE DEVELOPMENT OF IMPROVED METHODS OF TREATMENT AND MORE EFFECTIVE STRATEGIES FOR PREVENTING ALCOHOLISM AND ALCOHOL-RELATED PROBLEMS. THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) SUPPORTS RESEARCH IN A BROAD RANGE OF DISCIPLINES AND SUBJECT AREAS RELATED TO BIOMEDICAL AND GENETIC FACTORS, PSYCHOLOGICAL AND ENVIRONMENTAL FACTORS, ALCOHOL-RELATED PROBLEMS AND MEDICAL DISORDERS, HEALTH SERVICES RESEARCH, AND PREVENTION AND TREATMENT RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION AND TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.273 - Alcohol Research Programs

National Institute on Alcohol Abuse and Alcoholism (NIAAA) [HHS - NIH]

New York, New York 100122338 United States

Single Zip Code

Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD), Research Project (U01 Clinical Trial optional) (RFA-AA-21-010)

Amendment Since initial award the total obligations have increased 762% from $372,849 to $3,213,267.