Development of Education Materials for Prevention of FAS in Russia

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971398
• Other study ID #: RTO1 2005-999-01
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: October 23, 2013
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2013
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Related Neurodevelopmental Disorder
• Alcohol Use Complicating Pregnancy, Unspecified Trimester
• Disease
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome (FAS)
• Mental Disorders Diagnosed in Childhood
• Pregnancy Complications

Intervention

Behavioral:
• Positive FASD education brochure
Exposure to a positive FASD education brochure
• Negative FASD education brochure
Exposure to a negative FASD education brochure
• Active comparator (a general women's health brochure)
Exposure to a general women's health brochure

Locations

Country	Name	City	State
Russian Federation	Nizhny Novgorod State Pedagogical University	Nizhny Novgorod
Russian Federation	St. Petersburg State University	St. Peterburg
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Centers for Disease Control and Prevention

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline	A survey measure assessed knowledge about FAS	1 month follow-up	No
Primary	Changes in attitudes from baseline	A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy	1 month follow-up	No
Primary	Changes in alcohol consumption from baseline	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.	1 month follow-up	No
Secondary	Responses to brochures	A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.	After the intervention (reading an information brochure)	No

External Links

•   Information about the research project, the University of Oklahoma Health Sciences Center (OUHSC) website