Clinical Trial: Preventing FAS/ARND in Russian Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preventing FAS/ARND in Russian Children

Brief 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.

Detailed Summary: 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.
Sponsor: University of Oklahoma

Current Primary Outcome:

• Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months [ Time Frame: 3 months ]
  Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
• Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months [ Time Frame: 6 months ]
  Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.
• Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months [ Time Frame: 12 months ]
  Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Changes in alcohol consumption from baseline [ Time Frame: 3 months, 6 months, and 12 months 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.
• Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline [ Time Frame: 3 months, 6 months, and 12 months follow-up ]
  A survey measure assessed knowledge about FAS
• Changes in Health beliefs and attitudes from baseline [ Time Frame: 3 months, 6 months, and 12 months follow-up ]
  A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy

Original Secondary Outcome: Same as current

Information By: University of Oklahoma

Dates:
Date Received: October 8, 2013
Date Started: September 2007
Date Completion:
Last Updated: February 18, 2016
Last Verified: February 2016