NCT07547696

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

April 2, 2026

Last Update Submit

April 16, 2026

Conditions

Fetal Alcohol Spectrum DisordersPregnancyAlcohol-Related DisordersDrinking, AlcoholContraception BehaviorAlcohol Exposed PregnancySexual Behavior

Keywords

Native Americanfemaleadultcontraceptionalcoholdigital interventionmobile health (mHealth)optimizationrisk reduction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Rate of risky alcohol use

    3 months

  • Rate of risky contraception

    3 months

Study Arms (8)

1. New intervention components: All Off

OTHER

CARRII Cores New intervention components: All Off

Other: CARRII Native Cores

2. New intervention components: C

OTHER

CARRII Cores New intervention components: C

Other: CARRII Native Cores

3. New intervention components: B

OTHER

CARRII Cores New intervention components: B

Other: CARRII Native Cores

4. New intervention components: B and C

OTHER

CARRII Cores New intervention components: B and C

Other: CARRII Native Cores

5. New intervention components: A

OTHER

CARRII Cores New intervention components: A

Other: CARRII Native Cores

6. New intervention components: A and C

OTHER

CARRII Cores New intervention components: A and C

Other: CARRII Native Cores

7. New intervention components: A and B

OTHER

CARRII Cores New intervention components: A and B

Other: CARRII Native Cores

8. New intervention components: A, B, and C

OTHER

CARRII Cores New intervention components: A, B, and C

Other: CARRII Native Cores

Interventions

CARRII Native CoresOTHER

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

1. New intervention components: All Off2. New intervention components: C3. New intervention components: B4. New intervention components: B and C5. New intervention components: A6. New intervention components: A and C7. New intervention components: A and B8. New intervention components: A, B, and C

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Fontaine Research Park

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum DisordersAlcohol-Related DisordersAlcohol DrinkingContraception BehaviorSexual BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorReproductive Behavior

Study Officials

  • Karen S Ingersoll, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen S Ingersoll, PhD

CONTACT

434-982-5960KES7A@uvahealth.org

Silvia P Park, BA

CONTACT

434-924-3991spp2d@uvahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Psychiatry and NB Sciences

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 23, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations

US(1)