An interventional study of Dual-Focused Brief Physician Intervention (DFBPI) and Services as usual in Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders and Alcohol Abuse in Pregnancy, sponsored by University of Oklahoma. Completed at 2 sites in Russian Federation. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention
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.
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.
63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's enrollment of 767 is above the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dual-Focused Brief Physician Intervention (DFBPI)
Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)
Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.
Other: Services as usual
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.
Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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
Time frame: 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
Time frame: 3 months, 6 months, and 12 months follow-up
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Fetal Alcohol Spectrum Disorders→
University of Oklahoma