Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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