Reducing Alcohol Exposed Pregnancies

Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies

The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can:

1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and
2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Intervention condition, the usual prenatal care plus the alcohol intervention

Detailed Description

Prenatal alcohol exposure (PAE) increases the risk for Fetal Alcohol Spectrum Disorders (FASD). To address this health threat, researchers at New York University (NYU), the University of Texas Health Science Center-Houston, Purdue University, Health Resources in Action and the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) will develop, implement, and evaluate an alcohol intervention for women in prenatal care. This study is a randomized controlled trial (N=600) to assess the efficacy of an 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. Eligible women complete a baseline assessment by a research nurse consisting of an Audio Computer-Assisted Self Interview (ACASI) and collection of bloodspots for phosphatidylethanol (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 nurse-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 Screening, brief intervention and referral to treatment (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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Lunstroth; Phone Number: 1-888-472-9868; Email: cphs@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center, Houston
      • Contact: Angela Stotts, PhD; Phone Number: 713-500-7590; Email: Angela.L.Stotts@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 years and above
• Gestational age is 8 weeks or less
• Recent alcohol use as assessed by a positive EtG or self-report of alcohol use in the previous 21 days

Exclusion Criteria:

• Under 18 years of age
• Not pregnant or gestational age over 8 weeks
• No recent alcohol use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention condition, the usual prenatal care plus the alcohol intervention; The alcohol intervention consists of (1) a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions.	Behavioral: Intervention condition, the usual prenatal care plus the alcohol intervention; The intervention is theory-driven, based on Motivational Enhancement Theory (MET), and uses motivational strategies to promote alcohol reduction.
No Intervention: Comparison condition, usual prenatal care only; Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative PEth among women	Proportion of women detected with a laboratory-confirmed negative PEth test during pregnancy	Through study completion, on average 6 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-term births	Proportion of infants whose gestational age is <37 weeks	At birth
Low birth weight	Proportion of infants who weighed less than 2500 grams at birth	At birth

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: The University of Texas Health Science Center, Houston; Purdue University; Health Resources in Action, Inc.
• Investigators: Principal Investigator: Ralph DiClemente, PhD, New York University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): April 30, 2027

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: alcohol drinking in pregnancy; alcohol-exposed pregnancies; alcohol-related adverse birth outcomes
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 1U01AA030187-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IDP will be shared to other researchers as part of the CIFASD data sharing protocol
• IPD Sharing Time Frame: The data will become available after the study completion for a period of 5 years
• IPD Sharing Access Criteria: Will be available via the CIFASD data repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No