Preventing FAS/ARND in Russian Children

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 767
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Nizhniy Novgorod, Russian Federation, 603950
    • Women's clinics
  • St. Peterburg, Russian Federation, 199034
    • Women's clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 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.	3 months
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 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.	6 months
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Fogarty International Center of the National Institute of Health; St. Petersburg State Pavlov Medical University; Nizhny Novgorod State Pedagogical University

Publications and helpful links

General Publications

• Balachova T, Bonner BL, Chaffin M, Isurina G, Shapkaitz V, Tsvetkova L, Volkova E, Grandilevskaya I, Skitnevskaya L, Knowlton N. Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia. Addict Sci Clin Pract. 2013 Jan 8;8(1):1. doi: 10.1186/1940-0640-8-1.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (ESTIMATE): October 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy; alcohol; prevention; FAS; fetal exposure; Alcohol-Related Neurodevelopmental Disorder (ARND)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Alcoholism; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: R01AA016234_IRB 2758; 5R01AA016234 (NIH)