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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AA016234 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Fogarty International Center of the National Institute of Health | NIH |
| St. Petersburg State Pavlov Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Dual-Focused Brief Physician Intervention (DFBPI) |
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| Standard care | Other | Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-Focused Brief Physician Intervention (DFBPI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Balachova, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Clinics | Nizhny Novgorod | 603950 | Russia | |||
| Women's clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23294846 | Result | 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. |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Nizhny Novgorod State Pedagogical University | UNKNOWN |
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| Services as usual | Other | Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual. |
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| 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 |
| 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 |
| Saint Peterburg |
| 199034 |
| Russia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |