Recruiting

Motivational Intervention

Sponsor:

New York University

Code:

NCT05766761

Conditions

Alcohol Drinking

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention condition, the usual prenatal care plus the alcohol intervention

Study Details

Brief summary:

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.

Conditions

Alcohol Drinking

Study ID

NCT05766761

Start date

Apr 15, 2024

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years and above
  • Gestational age is 28 weeks or less
  • Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days

Exclusion Criteria:

  • Under 18 years of age
  • Not pregnant or gestational age over 28 weeks
  • No recent alcohol use as assessed by self-report

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Comparison condition, usual prenatal care only

Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

Interventions

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.

Primary outcome measure

  • Negative PEth among women [ Time Frame: Through study completion, on average 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Rebecca Lunstroth

1-888-472-9868cphs@uth.tmc.edu

Locations

The University of Texas Health Science Center, Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Angela Stotts, PhD

713-500-7590Angela.L.Stotts@uth.tmc.edu

More Information

Sponsor

New York University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • alcohol drinking in pregnancy
  • alcohol-exposed pregnancies
  • alcohol-related adverse birth outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2026-04-13.