Digital Intervention for Alcohol-Exposed Pregnancy Prevention

(CARRIINative 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

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test a digital app to help Native American women prevent pregnancies affected by alcohol. Researchers seek to gather information to create an app that aligns with the cultural needs and preferences of these women and then test various features of the app. Participants might try new tools like safer sex training or receive helpful reminders via text. Native American women at risk for alcohol-exposed pregnancies and who wish to reduce this risk may find this trial suitable. As an unphased trial, this study offers participants the chance to contribute to culturally tailored solutions for their community.

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 prior data suggests that this digital intervention is safe for Native American women?

Research has shown that digital programs to prevent alcohol-exposed pregnancies (AEP) have succeeded in past studies. One study demonstrated that a web-based program reduced the risk of AEP among 458 women, with 58% of these women no longer at risk after using the program.

The digital program aims to assist women who might consume alcohol during pregnancy. This is crucial because alcohol consumption during pregnancy can lead to serious conditions known as Fetal Alcohol Spectrum Disorders (FASDs). Digital programs are generally safe, involving online activities and educational content, which pose less risk compared to traditional medical treatments.

Overall, evidence suggests that the digital program is both effective and safe for women at risk of alcohol-exposed pregnancies. Participants in these studies have managed the programs well, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a novel digital approach to preventing alcohol-exposed pregnancies. Unlike standard methods that might involve in-person counseling or traditional educational programs, this intervention uses digital platforms to deliver personalized support and education, making it more accessible and potentially more engaging for participants. The trial explores innovative components like timeline follow-back assessments, digital skills training, and automated text prompts, which aim to enhance users' self-efficacy and readiness to change behaviors related to alcohol use and contraception. By leveraging technology, this method could provide a more flexible and culturally tailored approach to addressing a critical public health issue.

What evidence suggests that this digital intervention is effective for preventing alcohol-exposed pregnancies?

Research has shown that a web-based program like the Digital AEP Risk Intervention helped 58% of women reduce their risk of alcohol-exposed pregnancies. Such pregnancies can lead to serious health issues, including Fetal Alcohol Spectrum Disorders (FASD). In this trial, participants will engage in different arms, such as a survey arm and a rapid pilot testing arm, to evaluate various digital components aimed at reducing alcohol-exposed pregnancies. Prevention efforts target women who drink alcohol and do not use birth control. These methods have shown promise in reducing the risk of alcohol-exposed pregnancies. Digital tools that inform and support women can help them make healthier choices before becoming pregnant. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Rapid Pilot Testing Experimental Treatment 1 Intervention

Participants will complete a baseline past month TLFB (timeline follow-back) of alcohol use and contraception use during sex and a short online survey evaluating knowledge about AEP risk, intentions to change, self-efficacy for change, and readiness to change alcohol use and contraception behaviors. Each cohort of 10 participants will receive one of the 5 novel components (telephone-administered TLFB 2 weeks after study enrollment, mailed pregnancy test arriving 10-14 days after enrollment, digital safer sex and drink reduction skills training accessible across the 6-week period, automated texting prompting usage of skills across the 6-week period, or anonymized community message board across the 6-week period). Participants will complete a second TLFB for the past 6 weeks, and a short survey to rate the component they experienced, a System Usability Scale on their component, and measures of short-term knowledge, intentions to change, self-efficacy for change, and readiness to change.

Group II: Aim 1 Survey Active Control 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5984155/

A Pilot RCT of an Internet Intervention to Reduce the Risk ... These data show that CARRII was acceptable, feasible, promising to reduce AEP risk, and merits further testing in a fully powered RCT. Keywords: alcohol-exposed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06324929?cond=alcohol&aggFilters=status%3Arec

Study Details | Optimizing a Digital AEP Risk Intervention ... Alcohol exposed pregnancy (AEP) can result in Fetal Alcohol ... Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000903

A virtual randomized controlled trial of an alcohol-exposed ... Prevention of alcohol exposed pregnancies (AEPs), which can cause FASD, is typically aimed at adult women who are risky drinkers and have unprotected sex. Among ...

4. withpower.com withpower.com/trial/digital-intervention-for-alcohol-exposed-pregnancy-prevention-853ee

Digital Intervention for Alcohol-Exposed Pregnancy ... 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/acer.70072

Impact on alcohol‐exposed pregnancy (AEP) risk reduction ... Prevention interventions that target women during the preconception period, however, have shown great potential for reducing the risk of AEP ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11789002/

Identifying patients at risk for alcohol-exposed pregnancies Results of the overall systematic review indicated that many of the 19 interventions reduced AEP risk during the preconception period by ...

7. mdpi.com mdpi.com/1660-4601/16/10/1795

Community Perceptions of Alcohol Exposed Pregnancy ... The pre-conceptional prevention of alcohol-exposed pregnancies (AEP) focuses on preventing unintended pregnancies among women who are drinking ...