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Not yet recruiting Not applicable NCT07547696

CARRII Native Intervention Optimization Trial

No applicable phase (e.g. observational)
Conditions: Fetal Alcohol Spectrum Disorders Pregnancy Alcohol-Related Disorders Drinking, Alcohol Contraception Behavior Alcohol Exposed Pregnancy Sexual Behavior

Sponsor: University of Virginia

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Overview
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.
Description
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).
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.
Interventions
CARRII Native Cores
OTHER
Locations 1
United States (1)
University of Virginia Fontaine Research Park
Charlottesville , Virginia
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
44 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
30.04.2028
Registry ID
NCT07547696
Source
clinicaltrials.gov
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