An interventional study of CARRII Native Cores in Fetal Alcohol Spectrum Disorders, Pregnancy and Alcohol-Related Disorders, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Virginia · Not applicable, Interventional, and Other
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.
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).
65 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
This study's planned enrollment of 512 is above the median of 74 across 57 interventional studies indexed under Fetal Alcohol Spectrum Disorders.
Browse Fetal Alcohol Spectrum Disorders studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CARRII Cores New intervention components: All Off
Other: CARRII Native Cores
CARRII Cores New intervention components: C
Other: CARRII Native Cores
CARRII Cores New intervention components: B
Other: CARRII Native Cores
CARRII Cores New intervention components: B and C
Other: CARRII Native Cores
CARRII Cores New intervention components: A
Other: CARRII Native Cores
CARRII Cores New intervention components: A and C
Other: CARRII Native Cores
CARRII Cores New intervention components: A and B
Other: CARRII Native Cores
CARRII Cores New intervention components: A, B, and C
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Rate of Alcohol Exposed Pregnancy (AEP) Risk
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.
Time frame: 3 months
Rate of risky alcohol use
This outcome will measure the rate of risky alcohol use in the past month, at 3 months follow-up via daily diary reporting. For women, risky alcohol use is drinking more than 7 standard drinks per week, or more than 3 standard drinks per occasion, or both.
Time frame: 3 months
Rate of risky contraception
This outcome will measure the rate of risky contraception use in the past month, at 3 months follow-up via daily diary reporting. Risky contraception occurs when a fertile woman has sexual intercourse with a man without contraception, or using only ineffective methods, or using an effective method incorrectly or intermittently
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — This project will generate electronic, de-identified data that will be placed in a readily accessible public database of NIAAA data, which is managed in the NIMH Data Archive. Investigators will comply with all data sharing procedures specified by NIAAA and follow procedures described in the National Institute of Mental Health (NIMH) Data Archive (NDa) Sharing summary of tasks and expectations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 12 months after data analysis is completed, investigators will deposit it in the data archive
Access criteria: Other researchers can request data from the NIAAA Data Archive using their procedures.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
Of 28 interventional studies with no phase under Fetal Alcohol Spectrum Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Fetal Alcohol Spectrum Disorders →