Skip to main content
OpenTrials
Completed

NCT Number: NCT01971398

Development of Education Materials for Prevention of FAS in Russia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol Related Neurodevelopmental Disorder Alcohol Use Complicating Pregnancy, Unspecified Trimester Alcohol-Induced Disorders Alcohol-Related Disorders Behavior Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Syndrome (FAS) Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nizhny Novgorod State Pedagogical University, Nizhny Novgorod, Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive FASD education brochure

Behavioral

Exposure to a positive FASD education brochure

Negative FASD education brochure

Behavioral

Exposure to a negative FASD education brochure

Active comparator (a general women's health brochure)

Behavioral

Exposure to a general women's health brochure

Primary outcomes

  1. Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline

    Time frame: 1 month follow-up

    A survey measure assessed knowledge about FAS

  2. Changes in attitudes from baseline

    Time frame: 1 month follow-up

    A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy

  3. Changes in alcohol consumption from baseline

    Time frame: 1 month follow-up

    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 outcomes

  1. Responses to brochures

    Time frame: After the intervention (reading an information brochure)

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 29, 2013
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.