Preventing FAS/ARND in Russian Children

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title: Preventing FAS/ARND in Russian Children

Status Completed

Clinical Trial 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.

Clinical Trial Description

The study is a two-arm, 20-site, site-randomized, controlled trial testing an intervention to reduce risk for alcohol-exposed pregnancies in at-risk women (at-risk drinking childbearing age women who are heterosexually active, and not consistently using contraception). The trial will assess feasibility of a dual-focused (i.e. contraception use-drinking reduction) brief physician intervention (DFBPI) and determine whether physicians, trained in DFBPI and monitored for compliance, can foster greater reduction of women's risk behaviors compared to standard care. The intervention is specifically designed to be deliverable routinely by Obstetrics and Gynecology physicians(OB/GYN) to large numbers of women at women's clinics. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

• NCT number: NCT01961050
• Study type: Interventional
• Source: University of Oklahoma
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Completion date: July 2015