Preventing FAS/ARND in Russian Children

Not Applicable

Completed

• Conditions: Alcohol Abuse in Pregnancy; Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome (FAS)
• Interventions: Behavioral: Dual-Focused Brief Physician Intervention (DFBPI); Other: Services as usual

• Registration Number: NCT01961050
• Lead Sponsor: University of Oklahoma

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 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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 767

Inclusion Criteria

• nonpregnant women
• childbearing age (between 18 and 44 years of age)
• fertile
• at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months

Exclusion Criteria

• unable comprehend interview questions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dual-Focused Brief Physician Intervention (DFBPI)	Dual-Focused Brief Physician Intervention (DFBPI)
Standard care	Services as usual	Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Changes in alcohol consumption from baseline	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	3 months, 6 months, and 12 months follow-up	A survey measure assessed knowledge about FAS
Changes in Health beliefs and attitudes from baseline	3 months, 6 months, and 12 months follow-up	A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy

Trial Locations

Locations (2)

Women's Clinics; 🇷🇺 Nizhniy Novgorod, Russian Federation

Women's clinics; 🇷🇺 St. Peterburg, Russian Federation