Trials / Completed
CompletedNCT01961050
Preventing FAS/ARND in Russian Children
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 767 (actual)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- Female
- Age
- 18 Years – 44 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2013-10-11
- Last updated
- 2016-02-19
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT01961050. Inclusion in this directory is not an endorsement.