Preventing FAS/ARND in Russian Children
Primary Purpose
Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Dual-Focused Brief Physician Intervention (DFBPI)
Services as usual
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Alcohol Syndrome (FAS) focused on measuring alcohol, pregnancy, fetal exposure, prevention, FAS, Alcohol-Related Neurodevelopmental Disorder (ARND)
Eligibility 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
Sites / Locations
- Women's Clinics
- Women's clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Standard care
Arm Description
Dual-Focused Brief Physician Intervention (DFBPI)
Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
A survey measure assessed knowledge about FAS
Changes in Health beliefs and attitudes from baseline
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Full Information
NCT ID
NCT01961050
First Posted
October 8, 2013
Last Updated
February 18, 2016
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
1. Study Identification
Unique Protocol Identification Number
NCT01961050
Brief Title
Preventing FAS/ARND in Russian Children
Official Title
Preventing FAS/ARND in Russian Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy
Keywords
alcohol, pregnancy, fetal exposure, prevention, FAS, Alcohol-Related Neurodevelopmental Disorder (ARND)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
767 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Dual-Focused Brief Physician Intervention (DFBPI)
Arm Title
Standard care
Arm Type
Other
Arm Description
Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.
Intervention Type
Behavioral
Intervention Name(s)
Dual-Focused Brief Physician Intervention (DFBPI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Services as usual
Intervention Description
Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
Primary Outcome Measure Information:
Title
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
Description
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.
Time Frame
3 months
Title
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months
Description
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.
Time Frame
6 months
Title
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in alcohol consumption from baseline
Description
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.
Time Frame
3 months, 6 months, and 12 months follow-up
Title
Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
Description
A survey measure assessed knowledge about FAS
Time Frame
3 months, 6 months, and 12 months follow-up
Title
Changes in Health beliefs and attitudes from baseline
Description
A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy
Time Frame
3 months, 6 months, and 12 months follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Balachova, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Clinics
City
Nizhniy Novgorod
ZIP/Postal Code
603950
Country
Russian Federation
Facility Name
Women's clinics
City
St. Peterburg
ZIP/Postal Code
199034
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
23294846
Citation
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.
Results Reference
result
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Preventing FAS/ARND in Russian Children
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