RECRUITING

Reducing Alcohol Exposed Pregnancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Designing a Hybrid Intervention Strategy to Reduce Alcohol Exposed Pregnancies

Quick Facts

Study Start:2024-04-15
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and above
  2. * Gestational age is 28 weeks or less
  3. * Recent alcohol use as assessed by self-report of alcohol use in the previous 30 days
  1. * Under 18 years of age
  2. * Not pregnant or gestational age over 28 weeks
  3. * No recent alcohol use as assessed by self-report

Contacts and Locations

Study Contact

Rebecca Lunstroth
CONTACT
1-888-472-9868
cphs@uth.tmc.edu

Principal Investigator

Ralph DiClemente, PhD
PRINCIPAL_INVESTIGATOR
New York University

Study Locations (Sites)

The University of Texas Health Science Center, Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: New York University

  • Ralph DiClemente, PhD, PRINCIPAL_INVESTIGATOR, New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Alcohol Drinking