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Development of Education Materials for Prevention of FAS in Russia

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Contents

clinicaltrials.gov/study/NCT01971398
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT019713980
Trial Recruitment Size
4220
Trial Sponsor
University of Oklahoma
University of Oklahoma
0
Trial Collaborator
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
0
Clinical Trial Start Date
2007
0
Primary Completion Date
2007
0
Study Completion Date
2007
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
Nizhny Novgorod State Pedagogical University
Nizhny Novgorod State Pedagogical University
0
University of Oklahoma
University of Oklahoma
0
Official Name
Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia0
Last Updated
October 29, 2013
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Participant0
Outcomes Assessor0

Other attributes

Intervention Treatment
Active comparator (a general women's health brochure)0
Negative FASD education brochure0
Positive FASD education brochure0
Study 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.

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