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CARRII Native Intervention Optimization Trial

NCT07547696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Fetal Alcohol Spectrum Disorders
  • Pregnancy
  • Alcohol-Related Disorders
  • Drinking, Alcohol
  • Contraception Behavior
  • Alcohol Exposed Pregnancy
  • Sexual Behavior

Interventions

OTHER

CARRII Native Cores

4 Cores plus combination of 0, 1, 2, or 3 additional components

Sponsors & Collaborators

Principal Investigators

  • Karen S Ingersoll, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-03-31
Completion
2028-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547696 on ClinicalTrials.gov