Development of Education Materials for Prevention of FAS in Russia
Condition: Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome (FAS); Alcohol Related Neurodevelopmental Disorder; Alcohol Use Complicating Pregnancy, Unspecified Trimester
MeSH terms: Fetal Alcohol Spectrum Disorders; Pregnancy Complications; Syndrome; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      This study is designed to increase knowledge and awareness to prevent Fetal Alcohol Syndrome
      in Russian children through development of printed FAS education materials targeting women of
      childbearing age in Russia. Alcohol abuse is a major public health problem in Russia. The
      rates of FAS and Alcohol Related Neurodevelopmental Disorders (ARND) in Russia are not
      precisely known. At this time, there are no programs to prevent FAS in Russia. The results of
      our previous study, focus groups with health professionals, pregnant women and their
      partners, non-pregnant women, and women with alcohol dependency, indicated limited knowledge
      about FAS, misconceptions about alcohol use during pregnancy, and a lack of materials and
      print resources related to this topic. Based on the initial findings, this proposal aims to
      develop and evaluate in a clinical trial informational brochures for women to increase
      knowledge and reduce drinking during pregnancy in Russia. The main hypotheses to be tested
      are:

        -  1. Compared to the control group (CG) of women who receive a standard locally available
           flyer with health recommendations, women in the experimental groups who are exposed to
           printed information on FAS will show significantly more knowledge about FAS,
           significantly less acceptance of any alcohol use during pregnancy, and reduced drinking
           at one month follow-up assessment.

        -  2. The group exposed to a brochure with negative images (IGN - Intervention group with a
           "negative brochure") regarding drinking during pregnancy will show significantly greater
           change in the predicted directions compared to the group exposed to positive images (IGP
           - Intervention group with a "positive" brochure) at the one month follow-up assessment.
    

Detailed description: 
      The study utilizes a randomized controlled trial design to test the two types of brochures
      (with positive vs. negative images and statements) to determine if either approach has more
      effect on women's alcohol consumption.

      Pregnant and non-pregnant childbearing age women will be recruited at women's clinics and
      randomly assigned to participate in one of three groups: (1) participants will review the
      brochures that present information on FAS and alcohol use in pregnancy with positive images,
      (2) participants will review the brochures that that present information on FAS and alcohol
      use in pregnancy with negative, vivid images, and (3) participants will receive a general
      health information material that is available at their local clinics.

      All study participants will complete a baseline survey assessing their attitudes toward
      drinking during pregnancy, knowledge of FAS, and current alcohol use. After that, the
      intervention will be conducted. The women in the two experimental groups will receive a
      brochure with either positive (IGP) or negative (IGN) images. The women will be asked to read
      one of two brochures in the presence of the data collector. If the participants ask
      questions, the data collector will redirect the participants to material in the brochure.
      Following the intervention, the women in the experimental groups will complete a brief
      questionnaire to assess their emotional responses to the materials and perceived effects. The
      women assigned to the control group (CG) will be asked to read a brochure on general aspects
      of women's' health. At a one-month follow-up, women in all three groups will complete a
      post-test of self-reported alcohol consumption, knowledge about prenatal effects of alcohol
      and FAS, and attitudes to drinking during pregnancy.
    

Intervention name(s): Positive FASD education brochure; Negative FASD education brochure; Active comparator (a general women's health brochure)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Exposure to a positive FASD education brochure; Exposure to a negative FASD education brochure; Exposure to a general women's health brochure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fetal Alcohol Spectrum Disorders (FASD); Prevention; Alcohol-Exposed Pregnancy; Knowledge; Attitudes