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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026620
• Other study ID #: 12-1827
• Secondary ID: 5R01AA015134
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of the research is to find out if Motivational Enhancement Therapy is more effective than printed information alone (Informational pamphlets only) in helping women reduce their risk of giving birth to children with Fetal Alcohol Spectrum Disorders (FASD) at Primary Health Care Facilities, in addition to evaluation individuals for risky health behaviors by having them complete brief screening questionnaires that give them information of how much risk they might be facing from their alcohol or other drug use. When a pregnant mother drinks alcohol, she puts her baby at risk. FASD is a group of growth, mental, and physical problems that may occur in a baby when a mother drinks alcohol during pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Behavioral:
• Informational Pamphlet
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) Session
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.

Locations

Country	Name	City	State
South Africa	Stellenbosch University	Cape Town

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of New Mexico, University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Alcohol Use Disorders Identification Test (AUDIT) Score over time	The AUDIT is a 10-item, self-report, screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The AUDIT was developed and adopted by the World Health Organization. AUDIT scoring for questions 1 to 8 are scored on a five-point scale from 0,1,2,3, and 4; questions 9 and 10 are scored on a three-point scale from 0,2, and 4. The maximum score for the AUDIT is 40. AUDIT Total Score of 0-7 indicates a low-risk level; a score of 8-15 is risky or hazardous level; a score of 16-19 is a high-risk or harmful level; and 20 or more is considered high-risk/almost certainly dependent on alcohol.	Baseline through month 12