CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Rate of Alcohol Exposed Pregnancy (AEP) Risk
研究概览
简要总结
The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.
详细描述
In this protocol, for Aim 3, investigators will conduct a large 3-month factorial experiment with 512 participants. This design will identify the optimal intervention that efficiently balances AEP risk reduction with community-informed sustainable cost. Investigators will conduct exploratory analyses of mediation/moderation and identify study feasibility metrics (rates of Native women with AEP risk, and completing study recruitment, baseline, intervention, and follow-up vs. dropout) for a subsequent randomized control trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Native American/American Indian/Alaska Native,
- •who are not surgically sterile,
- •who report alcohol consumption at risk levels and risk for pregnancy in the past 90 days due to having sex with a man with inconsistent, ineffective, or no contraception.
- •Participants must have access to the Internet via a mobile device they can access daily
排除标准
- •cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.
研究组 & 干预措施
8. New intervention components: A, B, and C
CARRII Cores New intervention components: A, B, and C
干预措施: CARRII Native Cores (Other)
1. New intervention components: All Off
CARRII Cores New intervention components: All Off
干预措施: CARRII Native Cores (Other)
2. New intervention components: C
CARRII Cores New intervention components: C
干预措施: CARRII Native Cores (Other)
3. New intervention components: B
CARRII Cores New intervention components: B
干预措施: CARRII Native Cores (Other)
4. New intervention components: B and C
CARRII Cores New intervention components: B and C
干预措施: CARRII Native Cores (Other)
5. New intervention components: A
CARRII Cores New intervention components: A
干预措施: CARRII Native Cores (Other)
6. New intervention components: A and C
CARRII Cores New intervention components: A and C
干预措施: CARRII Native Cores (Other)
7. New intervention components: A and B
CARRII Cores New intervention components: A and B
干预措施: CARRII Native Cores (Other)
结局指标
主要结局
Rate of Alcohol Exposed Pregnancy (AEP) Risk
时间窗: 3 months
The primary outcome will be risk of alcohol-exposed pregnancy in the past month, at the 3 Month (3M) follow-up via daily diary reporting of alcohol consumption, intercourse and contraception use. AEP risk is defined as 1) had vaginal sex with a male during the past 4 weeks, 2) drank alcohol at risk levels during the past 30 days (For women, risky alcohol use is drinking more than 7 standard drinks per week, or more than 3 standard drinks per occasion, or both), 3) past month intermittent or no contraception, and 4) not being sterile and not having a partner (or partners) known to be sterile.
次要结局
- Rate of risky alcohol use(3 months)
- Rate of risky contraception(3 months)
研究者
Lee M Ritterband
Professor Psychiatry and NB Sciences
University of Virginia