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Development of Education Materials for Prevention of FAS in Russia

Primary Purpose

Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS), Alcohol Related Neurodevelopmental Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Positive FASD education brochure
Negative FASD education brochure
Active comparator (a general women's health brochure)
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Alcohol Spectrum Disorders focused on measuring Fetal Alcohol Spectrum Disorders (FASD), Prevention, Alcohol-Exposed Pregnancy, Knowledge, Attitudes

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma
  • Nizhny Novgorod State Pedagogical University
  • St. Petersburg State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Positive Brochure

Negative Brochure

A general women's health brochure

Arm Description

Women receive a "positive" FASD education brochure with positive images and are asked to read this brochure in the presence of a data collector.

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.

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.

Outcomes

Primary Outcome Measures

Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
A survey measure assessed knowledge about FAS
Changes in attitudes from baseline
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
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.

Secondary Outcome Measures

Responses to brochures
A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.

Full Information

First Posted
October 23, 2013
Last Updated
October 23, 2013
Sponsor
University of Oklahoma
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01971398
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Brochure
Arm Type
Experimental
Arm Description
Women receive a "positive" FASD education brochure with positive images and are asked to read this brochure in the presence of a data collector.
Arm Title
Negative Brochure
Arm Type
Experimental
Arm Description
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.
Arm Title
A general women's health brochure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive FASD education brochure
Intervention Description
Exposure to a positive FASD education brochure
Intervention Type
Behavioral
Intervention Name(s)
Negative FASD education brochure
Intervention Description
Exposure to a negative FASD education brochure
Intervention Type
Behavioral
Intervention Name(s)
Active comparator (a general women's health brochure)
Intervention Description
Exposure to a general women's health brochure
Primary Outcome Measure Information:
Title
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
Description
A survey measure assessed knowledge about FAS
Time Frame
1 month follow-up
Title
Changes in attitudes from baseline
Description
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Time Frame
1 month follow-up
Title
Changes in alcohol consumption from baseline
Description
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.
Time Frame
1 month follow-up
Secondary Outcome Measure Information:
Title
Responses to brochures
Description
A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.
Time Frame
After the intervention (reading an information brochure)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Balachova, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Bonner, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Nizhny Novgorod State Pedagogical University
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
St. Petersburg State University
City
St. Peterburg
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.oumedicine.com/pediatrics/department-sections/developmental-behavioral-pediatrics/center-on-child-abuse-and-neglect/research/fetal-alcohol-syndrome-research/development-of-education-materials
Description
Information about the research project, the University of Oklahoma Health Sciences Center (OUHSC) website

Learn more about this trial

Development of Education Materials for Prevention of FAS in Russia

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