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

• ClinicalTrials.gov Identifier: NCT04026620
• Recruitment Status: Active, not recruiting
• First Posted: July 19, 2019
• Last Update Posted: May 9, 2022
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of Stellenbosch; University of New Mexico; National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Fetal Alcohol Spectrum Disorders	Behavioral: Informational Pamphlet; Behavioral: Brief Motivational Enhancement Therapy (MET) Session	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Prevention
• Official Title: The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
• Actual Study Start Date: August 6, 2019
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Pamphlet-only; Pamphlet-only women will be provided with two (2) informational pamphlet(s) (both in Afrikaans).	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.
MET Group; 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; 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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in the Alcohol Use Disorders Identification Test (AUDIT) Score over time [ Time Frame: Baseline through month 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 44 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

South Africa

Stellenbosch University

Cape Town, South Africa

Sponsors and Collaborators

University of North Carolina, Chapel Hill

University of Stellenbosch

University of New Mexico

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Philip A May, Ph.D.; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04026620
• Other Study ID Numbers: 12-1827; 5R01AA015134 ( U.S. NIH Grant/Contract )
• First Posted: July 19, 2019
• Last Update Posted: May 9, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

alcohol use and abuse; prenatal alcohol use

Additional relevant MeSH terms:

Fetal Alcohol Spectrum Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders