CARRII Native Intervention Optimization Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARRII Native Cores.
- Who it may be relevant to
- Registry conditions: Fetal Alcohol Spectrum Disorders, Pregnancy, Alcohol-Related Disorders, Drinking, Alcohol. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions
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.
Detailed 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).
Interventions
- Other CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Primary outcome measures
- Rate of Alcohol Exposed Pregnancy (AEP) Risk [Time frame: 3 months]
Secondary outcome measures (2)
- Rate of risky alcohol use [Time frame: 3 months]
- Rate of risky contraception [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Virginia Fontaine Research Park — Charlottesville
Identifiers
NCT: NCT07547696 · SBS7390