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Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies.

Award Number: U01AA030187
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $751,604 )
2026	2026	NEW YORK UNIVERSITY	70 WASHINGTON SQ S FL 11	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	000	5	5/12/2026	NON-COMPETING CONTINUATION	$751,604
														Subtotal = $751,604

Issue Date FY: 2025 ( Subtotal = $747,810 )
2025	2025	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	001	4	8/19/2025	NON-COMPETING CONTINUATION	$747,810
2025	2024	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	000	3	11/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $747,810

Issue Date FY: 2024 ( Subtotal = $818,635 )
2024	2024	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	000	3	5/9/2024	NON-COMPETING CONTINUATION	$818,635
														Subtotal = $818,635

Issue Date FY: 2023 ( Subtotal = $1,273,973 )
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	002	2	6/1/2023	NON-COMPETING CONTINUATION	$871,938
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	003	2	9/25/2023	NON-COMPETING CONTINUATION	$0
2023	2023	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	001	1	3/9/2023	SUPPLEMENT FOR EXPANSION	$402,035
2023	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	000	1	3/9/2023	NEW	$0
														Subtotal = $1,273,973

Issue Date FY: 2022 ( Subtotal = $372,849 )
2022	2022	NEW YORK UNIVERSITY	70 WASHINGTON SQ S	NEW YORK	NY	10012	NEW YORK	USA	Alcohol Research Programs	000	1	9/5/2022	NEW	$372,849
														Subtotal = $372,849

Grand Total All Awards = $3,964,871

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Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies.

Award Number: U01AA030187

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/05/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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