Development of Education Materials for Prevention of FAS in Russia

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.

Conditions

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome (FAS)
• Alcohol Related Neurodevelopmental Disorder
• Alcohol Use Complicating Pregnancy, Unspecified Trimester

Interventions

BEHAVIORAL

Positive FASD education brochure

Exposure to a positive FASD education brochure

BEHAVIORAL

Negative FASD education brochure

Exposure to a negative FASD education brochure

BEHAVIORAL

Active comparator (a general women's health brochure)

Exposure to a general women's health brochure

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• University of Oklahoma

  lead OTHER

Principal Investigators

• Tatiana Balachova, PhD · University of Oklahoma

• Barbara Bonner, PhD · University of Oklahoma

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2007-12-31

Completion

2007-12-31

Countries

• United States
• Russia

Study Locations