Fetal Alcohol Spectrum DisordersNCT07547696
CARRII Native Intervention Optimization Trial
A study testing CARRII Native Cores in people with Fetal Alcohol Spectrum Disorders and Pregnancy, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders, Pregnancy, Alcohol-Related Disorders
- What is being tested?
- CARRII Native Cores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Fontaine Research Park
Charlottesville, Virginia, 22908
Karen Ingersoll, PhD, 8046516929, kes7a@uvahealth.org
About this study
Official title: CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions
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.
Read the 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).
- Conditions
- Fetal Alcohol Spectrum Disorders, Pregnancy, Alcohol-Related Disorders, Drinking, Alcohol, Contraception Behavior, Alcohol Exposed Pregnancy
- Being tested
- CARRII Native Cores
- Keywords
- Native American, female, adult, contraception, alcohol, digital intervention, mobile health (mHealth), optimization, risk reduction
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Alcohol-Related Disorders, Alcohol Drinking, Contraception Behavior, Sexual Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARRII Native CoresOther
4 Cores plus combination of 0, 1, 2, or 3 additional components
| Study group | Role | What they receive |
|---|---|---|
| 1. New intervention components: All Off | Other | CARRII Cores New intervention components: All Off Receives: Other: CARRII Native Cores |
| 2. New intervention components: C | Other | CARRII Cores New intervention components: C Receives: Other: CARRII Native Cores |
| 3. New intervention components: B | Other | CARRII Cores New intervention components: B Receives: Other: CARRII Native Cores |
| 4. New intervention components: B and C | Other | CARRII Cores New intervention components: B and C Receives: Other: CARRII Native Cores |
| 5. New intervention components: A | Other | CARRII Cores New intervention components: A Receives: Other: CARRII Native Cores |
| 6. New intervention components: A and C | Other | CARRII Cores New intervention components: A and C Receives: Other: CARRII Native Cores |
| 7. New intervention components: A and B | Other | CARRII Cores New intervention components: A and B Receives: Other: CARRII Native Cores |
| 8. New intervention components: A, B, and C | Other | CARRII Cores New intervention components: A, B, and C Receives: Other: CARRII Native Cores |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start2 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This design is a "wrapped" Multiphase Optimization Strategy (MOST) in which new components are all tested with the CARRII Core intervention. 512 participants will be randomized to one of 8 groups that receive a different combination of the 3 selected new components, plus the Native-tailored CARRII Core in a 2 full factorial design. Participants will receive a combination of zero, one, two, or three new intervention components, along with the CARRII core intervention. Each intervention component will be tested in two levels: on (component included) and off (component excluded). For example, participants in group 4 would receive the CARRII core intervention, new component B, and new component C but not new component A.
- Masking
- None (open label)
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Lee M Ritterband, University of Virginia
- Investigators
- Karen S Ingersoll, PhD, Principal investigator, University of VirginiaLee M Ritterband, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547696
- Sponsor's protocol ID
- SBS7390
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions
- ClinicalTrials.gov ID
- NCT07547696
- Acronym / sponsor ID
- SBS7390
- Conditions
- Fetal Alcohol Spectrum Disorders, Pregnancy, Alcohol-Related Disorders, Drinking, Alcohol, Contraception Behavior, Alcohol Exposed Pregnancy
- Keywords
- Native American, female, adult, contraception, alcohol, digital intervention, mobile health (mHealth), optimization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This design is a "wrapped" Multiphase Optimization Strategy (MOST) in which new components are all tested with the CARRII Core intervention. 512 participants will be randomized to one of 8 groups that receive a different combination of the 3 selected new components, plus the Native-tailored CARRII Core in a 2 full factorial design. Participants will receive a combination of zero, one, two, or three new intervention components, along with the CARRII core intervention. Each intervention component will be tested in two levels: on (component included) and off (component excluded). For example, participants in group 4 would receive the CARRII core intervention, new component B, and new component C but not new component A.
| Arm | Type | Receives |
|---|---|---|
| 1. New intervention components: All Off | Other | Other: CARRII Native CoresCARRII Cores New intervention components: All Off |
| 2. New intervention components: C | Other | Other: CARRII Native CoresCARRII Cores New intervention components: C |
| 3. New intervention components: B | Other | Other: CARRII Native CoresCARRII Cores New intervention components: B |
| 4. New intervention components: B and C | Other | Other: CARRII Native CoresCARRII Cores New intervention components: B and C |
| 5. New intervention components: A | Other | Other: CARRII Native CoresCARRII Cores New intervention components: A |
| 6. New intervention components: A and C | Other | Other: CARRII Native CoresCARRII Cores New intervention components: A and C |
| 7. New intervention components: A and B | Other | Other: CARRII Native CoresCARRII Cores New intervention components: A and B |
| 8. New intervention components: A, B, and C | Other | Other: CARRII Native CoresCARRII Cores New intervention components: A, B, and C |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARRII Native Cores4 Cores plus combination of 0, 1, 2, or 3 additional components | Other | 1. New intervention components: All Off, 2. New intervention components: C, 3. New intervention components: B, 4. New intervention components: B and C, 5. New intervention components: A, 6. New intervention components: A and C, 7. New intervention components: A and B, 8. New intervention components: A, B, and C |
Primary outcome
Rate of Alcohol Exposed Pregnancy (AEP) Risk
Time frame: 3 months
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.
2 secondary outcomes
Rate of risky alcohol use
Time frame: 3 months
Rate of risky contraception
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen S Ingersoll, PhD principal investigator
University of Virginia
Lee M Ritterband, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARRII Native Cores in people with Fetal Alcohol Spectrum Disorders and Pregnancy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia P Park, BA (855-488-2227, spp2d@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Alcohol Exposed Pregnancy (AEP) Risk (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.