Clinical Trial

CARRII Native Intervention Optimization Trial

Recruiting

Summary

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.

Protocol Amendment History 3 changes

critical Recruitment opened 2026-06-24

notable Primary completion pushed: 2028-03-31 -> 2028-06-30 2026-06-24

minor Completion pushed: 2028-04-30 -> 2028-07-30 2026-06-24

Trial Details

NCT Number	NCT07547696
Lead Sponsor	University of Virginia Collaborators: University of Minnesota
Conditions	Fetal Alcohol Spectrum Disorders, Pregnancy, Alcohol-Related Disorders, Drinking, Alcohol, Contraception Behavior, Alcohol Exposed Pregnancy, Sexual Behavior
Enrollment	512 participants
Start Date	2026-06-02
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-23