Digital Intervention for Alcohol-Exposed Pregnancy Prevention

(CARRII Native Trial)

Overseen By Silvia Park, BA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of AIM 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol.

Do I have to stop taking my current medications for the trial?

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

What data supports the effectiveness of the treatment Digital AEP Risk Intervention for preventing alcohol-exposed pregnancies?

Research shows that a web-based intervention similar to the Digital AEP Risk Intervention helped 58% of women reduce their risk of alcohol-exposed pregnancies within four months. This suggests that digital approaches can effectively reach and support women in reducing such risks. ^{1 2 3 4 5}

Is the digital intervention for preventing alcohol-exposed pregnancies safe for humans?

The digital intervention for preventing alcohol-exposed pregnancies has been tested in several studies and is generally considered safe for use in humans. It involves self-guided online sessions to help reduce the risk of alcohol-exposed pregnancies, and no safety concerns have been reported in the research. ^{2 3 4 5 6}

How does the digital intervention for alcohol-exposed pregnancy prevention differ from other treatments?

This digital intervention is unique because it is delivered remotely and is based on motivational interviewing, which is a counseling approach that helps people find the motivation to make positive decisions. Unlike traditional face-to-face methods, this treatment can reach a wider audience through online platforms, making it more accessible and scalable for women at risk of alcohol-exposed pregnancies. ^{2 3 4 7 8}

Eligibility Criteria

This trial is for Native American women who are interested in a digital app designed to help prevent pregnancies affected by alcohol. The study seeks participants engaged in sexual activity, using birth control, or with concerns about alcohol use and pregnancy.

Inclusion Criteria

Native American

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survey and Focus Groups

Participants complete surveys and participate in focus groups to gather data on AEP risk, preferences, and digital access

12 months

Ongoing participation

Think-aloud User Testing

Participants engage in user testing to finalize the CARRII Native intervention components

Ongoing within 12 months

1-2 sessions

Follow-up

Participants are monitored for feedback and effectiveness of the digital intervention

4 weeks

Treatment Details

Interventions

• Digital AEP Risk Intervention

Trial Overview The study is testing the effectiveness of a new digital application that works on smartphones, tablets, and computers. It aims to support Native American women in preventing unintended pregnancies influenced by alcohol consumption.

Participant Groups

Group I: Aim 1 Survey Experimental Treatment 1 Intervention

We will enroll up to 300 Native women ages 18-44 to complete a 35-minute survey to characterize demographics, parity, literacy, AEP risk, drinking levels, knowledge of FASD, location, Tribal affiliation, cultural preferences for tailoring, preferred digital platforms, methods of access to mobile devices/Internet, and interest in a digital women's health study about alcohol and birth control

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Missouri Breaks Industries Research, Inc.

Collaborator

Trials

8

Recruited

2,100+

Findings from Research

A one-session motivational interviewing intervention (EARLY) for preventing alcohol-exposed pregnancy (AEP) was tested on 217 at-risk women and resulted in significant reductions in ineffective contraception rates and AEP risk at 3 and 6 months.

While the EARLY intervention was effective, its impact was less powerful compared to multi-session interventions previously studied, suggesting it could serve as a more accessible option for AEP prevention in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk. Ingersoll, KS., Ceperich, SD., Hettema, JE., et al.[2022]

A web-based, self-guided intervention successfully reduced the risk of alcohol-exposed pregnancies (AEP) among 458 women at risk, with 58% no longer at risk after 4 months.

Both mail and online versions of the intervention were equally effective, demonstrating the potential of internet-based programs to reach and impact community health regarding AEP risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based intervention to reduce alcohol-exposed pregnancies in the community. Tenkku, LE., Mengel, MB., Nicholson, RA., et al.[2022]

The EARLY Remote intervention, a one-session motivational interviewing-based program delivered via telephone and mail, was found to be feasible and engaging for women at risk of alcohol-exposed pregnancy, showing good treatment credibility and integrity.

Significantly, the intervention led to a decrease in both the number of drinks per drinking day and the rate of unreliable contraception over 6 months, indicating its potential effectiveness in reducing the risk of alcohol-exposed pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and promise of a remote-delivered preconception motivational interviewing intervention to reduce risk for alcohol-exposed pregnancy. Farrell-Carnahan, L., Hettema, J., Jackson, J., et al.[2021]

The Contraception and Alcohol Risk Reduction Internet Intervention (CARRII) significantly reduced the risk of alcohol-exposed pregnancies (AEPs) by decreasing rates of unprotected sex and risky drinking among participants, with notable improvements observed from pretreatment to posttreatment and at 6-month follow-up.

In contrast, the static patient education website showed no significant changes in risky behaviors, highlighting CARRII's potential as an effective, scalable intervention for women at risk of AEPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot RCT of an Internet Intervention to Reduce the Risk of Alcohol-Exposed Pregnancy. Ingersoll, K., Frederick, C., MacDonnell, K., et al.[2022]

The Project Healthy CHOICES study found that college students at risk of alcohol-exposed pregnancies (AEPs) were significantly more likely (68%) to not be at risk compared to nonstudents (46%) after a 6-month follow-up, primarily due to effective contraception use.

Both the motivational feedback and information-only interventions did not show significant differences in outcomes, indicating that simply informing women about the risks of AEPs can be an effective public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Alcohol-Exposed Pregnancies: A Randomized Controlled Trial of a Self-Administered Version of Project CHOICES with College Students and Nonstudents. Sobell, LC., Sobell, MB., Johnson, K., et al.[2018]

An estimated 54% of pregnancies in the U.S. are exposed to alcohol, with unintended pregnancies accounting for 80% of those exposures, highlighting a significant public health concern.

Focusing solely on promoting alcohol abstinence among women who know they are pregnant could only reduce alcohol-exposed pregnancies by 42%, while combining this with strategies to prevent unintended pregnancies could lead to an 80% reduction, indicating the need for comprehensive public health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the Prevalence of Alcohol-Exposed Pregnancies in the United States: A Simulation Modeling Study. Yaesoubi, R., Mahin, M., Martin, G., et al.[2022]

The Healthy Choices study demonstrated that both telephone and in-person brief interventions effectively reduced the risk of alcohol-exposed pregnancies among women aged 18 to 44 who were drinking above recommended levels and not using effective contraception.

Participants showed small but significant reductions in alcohol use and larger increases in effective contraception use, indicating that improving contraception was the primary factor in reducing the risk of alcohol-exposed pregnancies, with no significant difference in effectiveness between the two intervention methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telephone versus in-person brief intervention to reduce the risk of an alcohol-exposed pregnancy. Wilton, G., Moberg, DP., Van Stelle, KR., et al.[2021]

A study involving 71 women at risk for alcohol-exposed pregnancy (AEP) found strong agreement between data collected from online daily diaries and the standard retrospective timeline follow back method for assessing drinking and unprotected sex, indicating both methods are reliable for evaluating AEP risk.

Despite the strong correlation, 63% of participants reported problem alcohol use and unprotected sex at baseline, highlighting the significant risk factors present in this population, which researchers and clinicians need to address in interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convergence of online daily diaries and timeline followback among women at risk for alcohol exposed pregnancy. Chow, PI., Lord, HR., MacDonnell, K., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A web-based intervention to reduce alcohol-exposed pregnancies in the community. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility and promise of a remote-delivered preconception motivational interviewing intervention to reduce risk for alcohol-exposed pregnancy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A Pilot RCT of an Internet Intervention to Reduce the Risk of Alcohol-Exposed Pregnancy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Preventing Alcohol-Exposed Pregnancies: A Randomized Controlled Trial of a Self-Administered Version of Project CHOICES with College Students and Nonstudents. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Reducing the Prevalence of Alcohol-Exposed Pregnancies in the United States: A Simulation Modeling Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized trial comparing telephone versus in-person brief intervention to reduce the risk of an alcohol-exposed pregnancy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Convergence of online daily diaries and timeline followback among women at risk for alcohol exposed pregnancy. [2018]