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

NCT04026620 | Completed Results

• 2 other identifiers: 12-18275R01AA015134
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

alcohol use and abuse; prenatal alcohol use

Outcome Measures

Primary Outcomes (1)

• 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, or 4; questions 9 and 10 are scored on a three-point scale from 0,2, or 4. The minimum total score for the AUDIT is 0. The maximum total score for the AUDIT is 40. Interpretation of the AUDIT Total Score is as follows: 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 9 months post-partum, an average of approximately 67 weeks.

Study Arms (2)

Pamphlet-only

OTHER

Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).

Behavioral: Informational Pamphlet

MET Group

OTHER

MET women will be provided with a one (1) hour and 30 minute session of Motivational Enhancement Therapy (MET) and informational pamphlet(s) (both in Afrikaans).

Behavioral: Informational Pamphlet; Behavioral: Brief Motivational Enhancement Therapy (MET) Session

Interventions

Informational Pamphlet BEHAVIORAL

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.

MET Group; Pamphlet-only

Brief Motivational Enhancement Therapy (MET) Session BEHAVIORAL

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.

MET Group

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Non-drinking pregnant women who are defined as women who have not had any alcohol during the past 30 days.
• Gestational age \>20 weeks

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Stellenbosch: collaborator
• University of New Mexico: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Stellenbosch University

Cape Town, South Africa

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Alcohol Drinking

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior

Results Point of Contact

• Title: Julie Hasken, PhD
• Organization: University of North Carolina at Chapel Hill

julie_hasken@unc.edu

704-250-5000

Study Officials

• Philip A May, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 400 women who screen positive for drinking will be asked if they want to be enrolled in the efficacy trial. Once a participant enrolls into the efficacy trial study, they are then randomly assigned to either the MET (Motivational Enhancement Therapy) group or informational pamphlet-only group. The MET group will be provided: 1.) a one (1) hour and 30 minute MET session, 2.) an information pamphlet on FASD written in simple Afrikaans. Women in the control condition will receive two informational pamphlets (one on FASD advising abstinence from alcohol use and one describing fetal development, both in Afrikaans). The data obtained by nurses during a woman's initial prenatal clinic visit for all 400 participants (Self-administered Questionnaire and AUDIT), will be matched with deliveries of the newborns to monitor the birth outcomes of newborns of participating mothers.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: August 6, 2019
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)