Clinical trial NCT01961050: Preventing FAS/ARND in Russian Children
Official title: Preventing FAS/ARND in Russian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Syndrome (FAS)
Fetal Alcohol Spectrum Disorders
Alcohol Abuse in Pregnancy
Keywords: alcohol
pregnancy
fetal exposure
prevention
FAS
Alcohol-Related Neurodevelopmental Disorder (ARND)
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Fogarty International Center of the National Institute of Health
name: St. Petersburg State Pavlov Medical University
name: Nizhny Novgorod State Pedagogical University
First posted: 2013-10-11
Enrollment: 767
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
timeFrame: 3 months
measure: Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months
timeFrame: 6 months
measure: Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Changes in alcohol consumption from baseline
timeFrame: 3 months, 6 months, and 12 months follow-up
measure: Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline
timeFrame: 3 months, 6 months, and 12 months follow-up
measure: Changes in Health beliefs and attitudes from baseline
timeFrame: 3 months, 6 months, and 12 months follow-up
Other outcomes:
Locations:
city: Nizhniy Novgorod
country: Russian Federation
facility: Women's Clinics
city: St. Peterburg
country: Russian Federation
facility: Women's clinics
Study officials:
affiliation: University of Oklahoma
name: Tatiana Balachova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.