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Motivational Intervention
Alcohol Reduction Program for Preventing Alcohol Exposure During Pregnancy
N/A
Waitlist Available
Led By Ralph DiClemente, PhD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average 6 months post-enrollment
Awards & highlights
Study Summary
This trial will compare a computer-delivered alcohol reduction program to the usual care for pregnant women to see if it helps reduce alcohol use and improve birth outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if a computer-based program plus nurse support can help reduce drinking during pregnancy better than usual care. It uses motivational strategies to change behavior and aims to improve birth outcomes by decreasing positive PEth tests.See study design
What are the potential side effects?
Since this intervention involves educational content and personal motivation rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort discussing alcohol use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, on average 6 months post-enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average 6 months post-enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Negative PEth among women
Secondary outcome measures
Low birth weight
Pre-term births
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention condition, the usual prenatal care plus the alcohol interventionExperimental Treatment1 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.
Group II: Comparison condition, usual prenatal care onlyActive Control1 Intervention
Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.
Find a Location
Who is running the clinical trial?
New York UniversityLead Sponsor
226 Previous Clinical Trials
313,517 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,360 Total Patients Enrolled
Health Resources in Action, Inc.OTHER
4 Previous Clinical Trials
1,429 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention condition, the usual prenatal care plus the alcohol intervention
- Group 2: Comparison condition, usual prenatal care only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently recruiting participants?
"This trial, which was opened on January 1st 2024 and last updated on March 10th 2023 is not currently enrolling participants. Nevertheless, there are 252 other medical studies actively recruiting right now."
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