Preventing FAS/ARND in Russian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 4
- 主要终点
- Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nonpregnant women
- •childbearing age (between 18 and 44 years of age)
- •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
排除标准
- •unable comprehend interview questions
结局指标
主要结局
Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Changes in alcohol consumption from baseline(3 months, 6 months, and 12 months follow-up)
- Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline(3 months, 6 months, and 12 months follow-up)
- Changes in Health beliefs and attitudes from baseline(3 months, 6 months, and 12 months follow-up)