Alcohol Exposed Pregnancy, Alcohol-Related Disorders, Contraception Behavior, Drinking, Alcohol, Fetal Alcohol Spectrum Disorders, Pregnancy, Sexual Behavior
Conditions
Keywords
Native American, female, adult, contraception, alcohol, digital intervention, mobile health (mHealth), optimization, risk reduction
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.
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).
Interventions
OTHERCARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Sponsors
University of Virginia
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Alcohol Exposed Pregnancy (AEP) Risk | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of risky alcohol use | 3 months | 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. |
| Rate of risky contraception | 3 months | 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 |
Countries
United States
Contacts
CONTACTSilvia P Park, BA
PRINCIPAL_INVESTIGATORKaren S Ingersoll, PhD
University of Virginia
PRINCIPAL_INVESTIGATORLee M Ritterband, PhD
University of Virginia
Outcome results
None listed