Preventing FAS/ARND in Russian Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preventing FAS/ARND in Russian Children

Conditions
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Fetal Alcohol Syndrome (FAS), Fetal Alcohol Spectrum Disorders, Alcohol Abuse in Pregnancy

Intervention / Treatment
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* Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)
* Other: Services as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Dual-Focused Brief Physician Intervention (DFBPI) | Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)<br>* 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.<br>|
| Other: Standard care<br>Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided. | Other: Services as usual<br>* Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FAS, alcohol, pregnancy, fetal exposure, prevention, Alcohol-Related Neurodevelopmental Disorder (ARND)