search
Back to results

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

Primary Purpose

Fetal Alcohol Spectrum Disorders

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Informational Pamphlet
Brief Motivational Enhancement Therapy (MET) Session
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Alcohol Spectrum Disorders focused on measuring alcohol use and abuse, prenatal alcohol use

Eligibility Criteria

15 Years - 44 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stellenbosch University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pamphlet-only

MET Group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2019
Last Updated
May 10, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Stellenbosch, University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04026620
Brief Title
The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
Official Title
The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of Stellenbosch, University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
Keywords
alcohol use and abuse, prenatal alcohol use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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, and 3.) a logo tea/coffee mug to take home. 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pamphlet-only
Arm Type
Other
Arm Description
Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).
Arm Title
MET Group
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Informational Pamphlet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Enhancement Therapy (MET) Session
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Alcohol Use Disorders Identification Test (AUDIT) Score over time
Description
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.
Time Frame
Baseline through month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A May, Ph.D.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stellenbosch University
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs