Alcohol Abuse in Pregnancy, Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome (FAS)
Conditions
Keywords
alcohol, pregnancy, fetal exposure, prevention, FAS, Alcohol-Related Neurodevelopmental Disorder (ARND)
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.
Interventions
BEHAVIORALDual-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.
OTHERServices as usual
Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Fogarty International Center of the National Institute of Health
St. Petersburg State Pavlov Medical University
Nizhny Novgorod State Pedagogical University
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months | 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. |
| Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months | 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. |
| Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in alcohol consumption from baseline | 3 months, 6 months, and 12 months follow-up | 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. |
| Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline | 3 months, 6 months, and 12 months follow-up | A survey measure assessed knowledge about FAS |
| Changes in Health beliefs and attitudes from baseline | 3 months, 6 months, and 12 months follow-up | A survey measure assessed attitudes and health beliefs related to alcohol use during pregnancy |
Countries
Russia
Outcome results
None listed