CARRII Native Intervention Optimization Trial for Fetal Alcohol Spectrum Disorders
This study is testing different combinations of components with CARRII Native Cores, an online program designed to help Native American/American Indian/Alaska Native women reduce their risk of alcohol-exposed pregnancies (AEP). The goal is to find the most effective and affordable version of this program. You may be able to join if you are a Native American/American Indian/Alaska Native woman between 18 and 44 years old, are not surgically sterile, have consumed alcohol at risky levels, and have had unprotected sex with a man in the last 90 days. You also need daily internet access on a mobile device. The study will measure the rate of AEP risk after 3 months to see how well the interventions work. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 512 participants in a 3-month factorial experiment. This design helps researchers test multiple intervention components at once.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months to measure the rate of Alcohol Exposed Pregnancy (AEP) Risk.
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CARRII Native Intervention Optimization Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Karen S Ingersoll, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia
- Lee M Ritterband, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Rate of Alcohol Exposed Pregnancy (AEP) Risk3 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.