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Completed

NCT Number: NCT04026620

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

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.

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Key information

Conditions

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

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stellenbosch University

Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time

    Time frame: Baseline through 9 months post-partum, an average of approximately 67 weeks.

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of New Mexico
  • University of Stellenbosch

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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