CARRII Native Intervention Optimization Trial

Purpose

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.

Conditions

  • Fetal Alcohol Spectrum Disorders
  • Pregnancy
  • Alcohol-Related Disorders
  • Drinking, Alcohol
  • Contraception Behavior
  • Alcohol Exposed Pregnancy
  • Sexual Behavior

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
1. New intervention components: All Off 		CARRII Cores New intervention components: All Off
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
2. New intervention components: C 		CARRII Cores New intervention components: C
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
3. New intervention components: B 		CARRII Cores New intervention components: B
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
4. New intervention components: B and C 		CARRII Cores New intervention components: B and C
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
5. New intervention components: A 		CARRII Cores New intervention components: A
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
6. New intervention components: A and C 		CARRII Cores New intervention components: A and C
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
7. New intervention components: A and B 		CARRII Cores New intervention components: A and B
  • Other: CARRII Native Cores
    4 Cores plus combination of 0, 1, 2, or 3 additional components
Other
8. New intervention components: A, B, and C 		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

Recruiting Locations

University of Virginia Fontaine Research Park
Charlottesville, Virginia 22908
Contact:
Karen Ingersoll, PhD
8046516929
kes7a@uvahealth.org

More Details

Status
Recruiting
Sponsor
University of Virginia

Study Contact

Silvia P Park, BA
855-488-2227
spp2d@uvahealth.org

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).