Trial record 10 of 19 for:    fetal alcohol syndrome

Preventing FAS/ARND in Russian Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Petersburg State Pavlov Medical University
Nizhny Novgorod State Pedagogical University
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01961050
First received: October 8, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing FAS/ARND in Russian Children

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months, 6 months, and 12 months follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months, 6 months, and 12 months follow-up ] [ Designated as safety issue: No ]
    A survey measure assessed knowledge about FAS

  • Changes in Health beliefs and attitudes from baseline [ Time Frame: 3 months, 6 months, and 12 months follow-up ] [ Designated as safety issue: No ]
    A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy


Estimated Enrollment: 800
Study Start Date: September 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01961050

Locations
Russian Federation
Women's Clinics
Nizhniy Novgorod, Russian Federation, 603950
Women's clinics
St. Peterburg, Russian Federation, 199034
Sponsors and Collaborators
University of Oklahoma
St. Petersburg State Pavlov Medical University
Nizhny Novgorod State Pedagogical University
Investigators
Principal Investigator: Tatiana Balachova, PhD University of Oklahoma
  More Information

Additional Information:
Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01961050     History of Changes
Other Study ID Numbers: R01AA016234, 5R01AA016234
Study First Received: October 8, 2013
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
alcohol
pregnancy
fetal exposure
prevention
FAS
Alcohol-Related Neurodevelopmental Disorder (ARND)

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Alcoholism
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014