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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. New intervention components: All Off | Other | CARRII Cores New intervention components: All Off |
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| 2. New intervention components: C | Other | CARRII Cores New intervention components: C |
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| 3. New intervention components: B | Other | CARRII Cores New intervention components: B |
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| 4. New intervention components: B and C | Other | CARRII Cores New intervention components: B and C |
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| 5. New intervention components: A | Other | CARRII Cores New intervention components: A |
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| 6. New intervention components: A and C | Other | CARRII Cores New intervention components: A and C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARRII Native Cores | Other | 4 Cores plus combination of 0, 1, 2, or 3 additional components |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Rate of risky contraception |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia P Park, BA | Contact | 855-488-2227 | spp2d@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Karen S Ingersoll, PhD | University of Virginia | Principal Investigator |
| Lee M Ritterband, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Fontaine Research Park | Recruiting | Charlottesville | Virginia | 22908 | United States |
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.
12 months after data analysis is completed, investigators will deposit it in the data archive
Other researchers can request data from the NIAAA Data Archive using their procedures.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2026 | Apr 13, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| D019973 | Alcohol-Related Disorders |
| D000428 | Alcohol Drinking |
| D003268 | Contraception Behavior |
| D012725 | Sexual Behavior |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| 7. New intervention components: A and B | Other | CARRII Cores New intervention components: A and B |
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| 8. New intervention components: A, B, and C | Other | CARRII Cores New intervention components: A, B, and C |
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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 |
| 3 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D043762 | Reproductive Behavior |