Development of Education Materials for Prevention of FAS in Russia

NCT01971398 | Completed

• 1 other identifier: RTO1 2005-999-01
• Study Type: interventional
• Target: 422
• Locations: 2 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (3)

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

  A survey measure assessed knowledge about FAS

  1 month follow-up

• Changes in attitudes from baseline

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

  1 month follow-up

• 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.

  1 month follow-up

Secondary Outcomes (1)

• Responses to brochures

  After the intervention (reading an information brochure)

Study Arms (3)

Positive Brochure

EXPERIMENTAL

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

Negative Brochure

EXPERIMENTAL

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

A general women's health brochure

ACTIVE COMPARATOR

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)

Interventions

Positive FASD education brochure BEHAVIORAL

Exposure to a positive FASD education brochure

Positive Brochure

Negative FASD education brochure BEHAVIORAL

Exposure to a negative FASD education brochure

Negative Brochure

Active comparator (a general women's health brochure) BEHAVIORAL

Exposure to a general women's health brochure

A general women's health brochure

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Oklahoma: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Nizhny Novgorod State Pedagogical University

Nizhny Novgorod, Russia

Location

St. Petersburg State University

Saint Peterburg, Russia

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders; Behavior

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Tatiana Balachova, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Barbara Bonner, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: April 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

RU (2); US (1)