Development of Education Materials for Prevention of FAS in Russia

Not Applicable

Completed

• Conditions: Fetal Alcohol Spectrum Disorders; Alcohol Related Neurodevelopmental Disorder; Fetal Alcohol Syndrome (FAS); Alcohol Use Complicating Pregnancy, Unspecified Trimester
• Interventions: Behavioral: Positive FASD education brochure; Behavioral: Negative FASD education brochure; Behavioral: Active comparator (a general women's health brochure)

• Registration Number: NCT01971398
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Study First Posted: 2013-10-29
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 422

Inclusion Criteria

• Women
• Childbearing age (between 18 and 44 years of age)
• Sexually active (any intercourse with a partner in the last year)
• Consume alcohol (any level of alcohol consumption in the last year)

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Brochure	Positive FASD education brochure	Women receive a "positive" FASD education brochure with positive images and are asked to read this brochure in the presence of a data collector.
Negative Brochure	Negative FASD education brochure	Women receive a "negative" FASD education brochure with negative, vivid images and are asked to read this brochure in the presence of a data collector.
A general women's health brochure	Active comparator (a general women's health brochure)	Women receive a brochure on general aspects of women's health and pregnancy that is available in the Russian language and are asked to read this brochure in the presence of a data collector.

Primary Outcome Measures

Name	Time	Method
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline	1 month follow-up	A survey measure assessed knowledge about FAS
Changes in attitudes from baseline	1 month follow-up	A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Changes in alcohol consumption from baseline	1 month follow-up	Interviews assessed self-reported quantity/frequency of alcohol consumption and frequency of binge drinking and a detailed alcohol consumption report was received utilizing the Time Line Follow Back (TLFB) measure.

Secondary Outcome Measures

Name	Time	Method
Responses to brochures	After the intervention (reading an information brochure)	A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.

Trial Locations

Locations (3)

St. Petersburg State University; 🇷🇺 St. Peterburg, Russian Federation

Nizhny Novgorod State Pedagogical University; 🇷🇺 Nizhny Novgorod, Russian Federation

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States