Preventing FAS/ARND in Russian Children

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT01961050

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), Fogarty International Center of the National Institute of Health (NIH), St. Petersburg State Pavlov Medical University (Other), Nizhny Novgorod State Pedagogical University (Other)

767

Enrollment

Locations

Arms

Duration (Months)

383.5

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Alcohol Syndrome (FAS) Fetal Alcohol Spectrum Disorders Alcohol Abuse in Pregnancy	Behavioral: Dual-Focused Brief Physician Intervention (DFBPI) Other: Services as usual	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

767 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Preventing FAS/ARND in Russian Children

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Dual-Focused Brief Physician Intervention (DFBPI)	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: Standard care Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.	Other: Services as usual Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.

Arm

Intervention/Treatment

Experimental: Intervention

Dual-Focused Brief Physician Intervention (DFBPI)

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: Standard care

Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.

Other: Services as usual

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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