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Development of Education Materials for Prevention of FAS in Russia

NCT ID: NCT01971398

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Fetal Alcohol Spectrum Disorders (FASD) Prevention Alcohol-Exposed Pregnancy Knowledge Attitudes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Positive 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.

Group Type EXPERIMENTAL

Positive FASD education brochure

Intervention Type BEHAVIORAL

Exposure to a positive FASD education brochure

Negative 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.

Group Type EXPERIMENTAL

Negative FASD education brochure

Intervention Type BEHAVIORAL

Exposure to a negative FASD education brochure

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.

Group Type ACTIVE_COMPARATOR

Active comparator (a general women's health brochure)

Intervention Type BEHAVIORAL

Exposure to a general women's health brochure

Interventions

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Positive FASD education brochure

Exposure to a positive FASD education brochure

Intervention Type BEHAVIORAL

Negative FASD education brochure

Exposure to a negative FASD education brochure

Intervention Type BEHAVIORAL

Active comparator (a general women's health brochure)

Exposure to a general women's health brochure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatiana Balachova, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Barbara Bonner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Nizhny Novgorod State Pedagogical University

Nizhny Novgorod, , Russia

Site Status

St. Petersburg State University

Saint Peterburg, , Russia

Site Status

Countries

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United States Russia

Other Identifiers

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RTO1 2005-999-01

Identifier Type: -

Identifier Source: org_study_id