Preventing FAS/ARND in Russian Children

University of Oklahoma (OU)

Status: Completed

Conditions: Alcohol Abuse in Pregnancy; Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome (FAS)

Treatments: Other: Services as usual; Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01961050

R01AA016234_IRB 2758

5R01AA016234 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 767 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No 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

Exclusion criteria

• unable comprehend interview questions

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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767 participants in 2 patient groups

Intervention

Experimental group

Description:

Dual-Focused Brief Physician Intervention (DFBPI)

Treatment:

Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)

Standard care

Other group

Description:

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

Treatment:

Other: Services as usual