CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 167 enrolled
Drug / intervention
Informational Pamphlet +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04026620
NCT04026620N/ACompleted

The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology

University of North Carolina, Chapel Hill·interventional·Posted Jul 19, 2019·Updated Oct 8, 2024

In Brief

A clinical study evaluating Informational Pamphlet and Brief Motivational Enhancement Therapy (MET) Session for Fetal Alcohol Spectrum Disorders. Completed, enrolled 167 participants across 1 site.

Detailed Summary

Screen women of childbearing age (15 - 44 years) for high risk drinking in antenatal clinics of the established research sites in the Western Cape Province of South Africa (SA). While there are multiple reasons for this screening, the purpose is for selective (secondary) prevention of FASD. A.) Initiate a case control trial/efficacy study (n=400) of the use of one-session brief motivation enhancement therapy (MET) in busy public health settings (versus information only) in these rich research sites where very high rates of FASD have been documented over the entirety of the past two decades. B.) These targeted prevention activities follow both findings and staff experience in prevention over the past decade which indicate that the most likely venue for prevention activities is in antenatal clinics of the local, primary care clinics and hospitals. These activities will also provide tangible community-level pay back for participation in ongoing research activities and lay the groundwork for sustainable services going forward.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartAug 6, 2019
Primary CompletionOct 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.0 years ago

Interventions

Informational Pamphletbehavioral

The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.

Brief Motivational Enhancement Therapy (MET) Sessionbehavioral

The case control trial/efficacy study will provide a one-session MET session in Afrikaans (the predominant language of the region). The face-to-face session will provide information to help people and pregnant women who want to change their drinking behavior, become 'dry' and stay motivated to change their drinking behaviors. Sessions will be approximately one (1) hour and 30 minutes.