Development of Education Materials for Prevention of FAS in Russia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01971398
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of Education Materials for Prevention of Fetal Alcohol Syndrome (FAS) in Russia

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
    A survey measure assessed knowledge about FAS

  • Changes in attitudes from baseline [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
    A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy

  • Changes in alcohol consumption from baseline [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: After the intervention (reading an information brochure) ] [ Designated as safety issue: No ]
    A brief questionnaire to assess women's feedback, perceived effect, and emotional responses to health or FAS education brochures.


Enrollment: 422
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Positive FASD education brochure
Exposure to a positive FASD education brochure
Experimental: 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.
Behavioral: Negative FASD education brochure
Exposure to a negative FASD education 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.
Behavioral: Active comparator (a general women's health brochure)
Exposure to a general women's health brochure

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

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971398

Locations
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Russian Federation
Nizhny Novgorod State Pedagogical University
Nizhny Novgorod, Russian Federation
St. Petersburg State University
St. Peterburg, Russian Federation
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Tatiana Balachova, PhD University of Oklahoma
Principal Investigator: Barbara Bonner, PhD University of Oklahoma
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01971398     History of Changes
Other Study ID Numbers: RTO1 2005-999-01
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Fetal Alcohol Spectrum Disorders (FASD)
Prevention
Alcohol-Exposed Pregnancy
Knowledge
Attitudes

Additional relevant MeSH terms:
Disease
Syndrome
Fetal Alcohol Spectrum Disorders
Pregnancy Complications
Pathologic Processes
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014