Clinical trial NCT04026620: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Keywords: alcohol use and abuse
prenatal alcohol use
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
name: University of New Mexico
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-19
Enrollment: 167
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in the Alcohol Use Disorders Identification Test (AUDIT) Score Over Time
timeFrame: Baseline through 9 months post-partum, an average of approximately 67 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Stellenbosch University
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Philip A May, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: