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

University of North Carolina (UNC)

Status: Completed

Conditions: Fetal Alcohol Spectrum Disorders

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04026620

12-1827

5R01AA015134 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: Female

Ages: 15 to 44 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Pamphlet-only

Other group

Description:

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

Treatment:

Behavioral: Informational Pamphlet

MET Group

Other group

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).

Treatment:

Behavioral: Informational Pamphlet

Behavioral: Brief Motivational Enhancement Therapy (MET) Session