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Preventing FAS/ARND in Russian Children

NCT01961050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 767

Last updated 2016-02-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. The study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women who are at risk than standard care.

Conditions

  • Fetal Alcohol Syndrome (FAS)
  • Fetal Alcohol Spectrum Disorders
  • Alcohol Abuse in Pregnancy

Interventions

BEHAVIORAL

Dual-Focused Brief Physician Intervention (DFBPI)

The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.

OTHER

Services as usual

Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • St. Petersburg State Pavlov Medical University

    collaborator OTHER

  • Nizhny Novgorod State Pedagogical University

    collaborator UNKNOWN

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Tatiana Balachova, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961050 on ClinicalTrials.gov