N/A
N=167
The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
Fetal Alcohol Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04026620 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time — -5.8; -4.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Informational Pamphlet (Behavioral); Brief Motivational Enhancement Therapy (MET) Session (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time |
-5.8; -4.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Drinking pregnant women who are defined as women who:
- Drank in the 3 months prior to pregnancy and/or
- Drank alcohol at least once at any time during the prenatal period.
- Gestational age less than or equal to 16 weeks, but not more than 20 weeks at intake
Exclusion Criteria
- Non-drinking pregnant women who are defined as women who have not had any alcohol during the past 30 days.
- Gestational age >20 weeks
Data sourced from ClinicalTrials.gov (NCT04026620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.