The Trajectory of Fetal Alcohol Spectrum Disorders (FASD) Across the Life Span: Continuing Prevention and Longitudinal Epidemiology
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

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.
    

Intervention name(s): Informational Pamphlet; Brief Motivational Enhancement Therapy (MET) Session
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
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
Keywords: alcohol use and abuse; prenatal alcohol use