512 Participants NeededMy employer runs this trial

CARRII Native for Alcohol-Exposed Pregnancy

KS
SP
Overseen BySilvia P Park, BA
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination of online tools to reduce alcohol-exposed pregnancies among Native women and others who can become pregnant. It focuses on enhancing the CARRII Native, an online program, to increase its effectiveness and affordability for Native communities. Participants will test various combinations of new intervention components, known as CARRII Native Cores, to determine the most effective approach. Suitable candidates have reported risky alcohol consumption and potential pregnancy in the last 90 days, have internet access on a mobile device, and are Native American, American Indian, or Alaska Native. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative tools that could significantly benefit Native communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CARRII Native intervention is safe for alcohol-exposed pregnancies?

Research has shown that the CARRII Native Cores, an online tool to help reduce the risk of alcohol-exposed pregnancy, is generally well-received. One study found that users experienced mild side effects. This digital tool assists Native American women and others who can become pregnant in managing alcohol use and related behaviors. The tool aims to be safe and effective, and previous research supports that most users find the side effects manageable.12345

Why are researchers excited about this trial?

Researchers are excited about the CARRII Native Cores trial because it explores new intervention components for pregnancies affected by alcohol exposure. Unlike existing treatments that may focus on managing symptoms or providing general support, this approach looks at specific combinations of components labeled A, B, and C, which have the potential to target the condition more precisely. By experimenting with different combinations, such as A and C or A, B, and C together, researchers hope to uncover more effective strategies to support healthy pregnancy outcomes in cases of alcohol exposure. This kind of tailored approach could lead to more personalized and effective care options in the future.

What evidence suggests that this trial's treatments could be effective for alcohol-exposed pregnancies?

Research has shown that the CARRII Native program may help reduce the risk of pregnancies affected by alcohol. One study reported a noticeable decrease in unprotected sex among participants, from 88.9% before the program to 70.6% after. This improvement persisted over time, indicating lasting benefits. Additionally, a nationwide pilot study found that CARRII was more effective than a standard education program in lowering the risk of alcohol-exposed pregnancies. This trial will evaluate various intervention components of the CARRII Native program, such as components A, B, and C, to determine their effectiveness. These findings suggest that CARRII can be a useful tool for reducing this risk, especially for Native women and those who can become pregnant.34678

Who Is on the Research Team?

LM

Lee M Ritterband, PhD

Principal Investigator

University of Virginia

KS

Karen S Ingersoll, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for Native American, American Indian, or Alaska Native women who can become pregnant, have recently had unprotected sex with a man and drank alcohol at risky levels in the past 90 days. Participants must have daily access to the internet on their mobile device.

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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 3-month factorial experiment to identify optimal intervention components for reducing AEP risk

3 months

Follow-up

Participants are monitored for AEP risk and risky behaviors through daily diary reporting

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • CARRII Native Cores

Trial Overview

The study is testing different combinations of an online program called CARRII designed to help reduce drinking and prevent pregnancies exposed to alcohol among Native women. The goal is to find which parts work best while keeping costs low.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: 8. New intervention components: A, B, and CExperimental Treatment1 Intervention
Group II: 7. New intervention components: A and BExperimental Treatment1 Intervention
Group III: 6. New intervention components: A and CExperimental Treatment1 Intervention
Group IV: 5. New intervention components: AExperimental Treatment1 Intervention
Group V: 4. New intervention components: B and CExperimental Treatment1 Intervention
Group VI: 3. New intervention components: BExperimental Treatment1 Intervention
Group VII: 2. New intervention components: CExperimental Treatment1 Intervention
Group VIII: 1. New intervention components: All OffExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Citations

CARRII Native Intervention Optimization Trial

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 ...

A Pilot RCT of an Internet Intervention to Reduce the Risk of ...

CARRII participants showed significant reductions in rate of unprotected sex from pre-treatment (88.9%) to post-treatment (70.6%) (p<.04), and to 6M follow-up ( ...

CARRII Native for Alcohol-Exposed Pregnancy

The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online ...

CARRII: A Study for Native Women

The purpose of the study is to gather information to design a digital intervention (used on mobile phones, tablets, or computers) for Native American women.

Title: CARRII Native Intervention Optimization Trial

This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the ...

Optimizing a Digital AEP Risk Intervention with Native ...

Over 3.3 million US women per month are at risk for Alcohol-Exposed Pregnancy (AEP). Prenatal alcohol exposure can cause lifetime costly intellectual and ...

CARRII Native: Optimizing a Digital AEP Risk Intervention ...

CARRII Native is an automated digital behavioral intervention to reduce risk of Alcohol-Exposed Pregnancy among Native American women and others who can become ...

Title: Optimizing a Digital AEP Risk Intervention with Native ...

Alcohol exposed pregnancy (AEP) can result in Fetal Alcohol Spectrum Disorders (FASDs) that cause lifelong costly disabilities from brain ...