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Completed

NCT Number: NCT01961050

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.

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Key information

Conditions

Fetal Alcohol Syndrome (FAS) Alcohol Abuse in Pregnancy Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Clinics, Nizhny Novgorod, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual-Focused Brief Physician Intervention (DFBPI)

Behavioral

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.

Services as Usual

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

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

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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