Alcohol Reduction Program for Preventing Alcohol Exposure During Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help pregnant women reduce alcohol use by testing a new intervention against standard prenatal care. It will explore whether a motivational program, known as the "Intervention condition," can result in more women having negative alcohol tests during pregnancy and healthier babies. Participants will use a computer-based program and receive nurse support to encourage reducing alcohol consumption. Women who are less than 28 weeks pregnant and have recently consumed alcohol may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance prenatal care for future mothers.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing alcohol use during pregnancy.
What prior data suggests that this intervention is safe for pregnant women?
Research has shown that motivational programs can safely and effectively help pregnant women reduce alcohol use. These programs, offering both online and in-person support, have helped many women lower the risk of alcohol exposure to their babies. For example, one study found that 69% of participants reduced their risk of alcohol-exposed pregnancies.
These programs aim to increase understanding and motivation to drink less, using safe and non-invasive methods to encourage change. Importantly, no reports of serious side effects have emerged from participation, indicating that most women find them manageable.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it introduces a dual-component intervention to reduce alcohol exposure during pregnancy, which is different from the usual prenatal care. Unlike standard care that mainly involves clinician assessments and general counseling, this intervention combines a self-paced, computer-delivered component to boost knowledge and motivation with a personalized nurse-delivered component to address specific questions and reinforce learning. This innovative approach could lead to more effective alcohol reduction by tailoring support to individual needs and making education more engaging and accessible.
What evidence suggests that this motivational intervention is effective for reducing alcohol use during pregnancy?
Research has shown that motivational programs can help reduce alcohol use during pregnancy. In one study, 69% of women lowered their risk of having a baby exposed to alcohol after joining such a program. This trial includes an intervention condition where participants receive the usual prenatal care plus an alcohol intervention. The intervention consists of a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction, along with a nurse-delivered component to reinforce the content and address questions. These programs typically teach about the dangers of drinking while pregnant and encourage women to stop. Self-paced learning tools, combined with nurse support, have guided women to make healthier choices. Short programs have also been somewhat successful in helping women stop drinking during pregnancy and in preventing early births. Overall, these methods aim to provide women with the information and support needed to reduce alcohol use.12678
Who Is on the Research Team?
Ralph DiClemente, PhD
Principal Investigator
New York University
Are You a Good Fit for This Trial?
This trial is for pregnant women over 18, less than 8 weeks into their pregnancy, who have used alcohol in the last 21 days. It's not for those under 18, not pregnant or more than 8 weeks pregnant, and without recent alcohol use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Eligible women complete a baseline assessment including an Audio Computer-Assisted Self Interview (ACASI) and collection of bloodspots for phosphatidylethanol (PEth) analysis
Intervention
Participants receive a self-paced computer-delivered alcohol reduction intervention and a nurse-delivered component to reinforce the content
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of birth outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Intervention condition
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York University
Lead Sponsor
The University of Texas Health Science Center, Houston
Collaborator
Health Resources in Action, Inc.
Collaborator
Purdue University
Collaborator