Clinical trial NCT01971398: Development of Education Materials for Prevention of FAS in Russia
Official title: Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome (FAS)
Alcohol Related Neurodevelopmental Disorder
Alcohol Use Complicating Pregnancy, Unspecified Trimester
Keywords: Fetal Alcohol Spectrum Disorders (FASD)
Prevention
Alcohol-Exposed Pregnancy
Knowledge
Attitudes
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-10-29
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
timeFrame: 1 month follow-up
measure: Changes in attitudes from baseline
timeFrame: 1 month follow-up
measure: Changes in alcohol consumption from baseline
timeFrame: 1 month follow-up
Secondary outcomes:
measure: Responses to brochures
timeFrame: After the intervention (reading an information brochure)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod State Pedagogical University
city: St. Peterburg
country: Russian Federation
facility: St. Petersburg State University
Study officials:
affiliation: University of Oklahoma
name: Tatiana Balachova, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Barbara Bonner, PhD
role: PRINCIPAL_INVESTIGATOR
References: