Preventing FAS/ARND in Russian Children

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Preventing FAS/ARND in Russian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961050
• Other study ID #: R01AA016234_IRB 2758
• Secondary ID: 5R01AA016234
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: February 18, 2016
• Start date: September 2007
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abuse in Pregnancy
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome (FAS)

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Women's Clinics	Nizhniy Novgorod
Russian Federation	Women's clinics	St. Peterburg

Sponsors (5)

Lead Sponsor	Collaborator
University of Oklahoma	John E. Fogarty International Center (FIC), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Nizhny Novgorod State Pedagogical University, St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Information about the research project, the University of Oklahoma Health Sciences Center (OUHSC) website