e-Intervention for Alcohol Use in Pregnancy

(e-Health Trial)

Overseen By Lisa M Todd, MS, JD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Not carrying to term, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app called MommyCheckup, designed to help pregnant women reduce alcohol use. Researchers aim to determine if the app is effective on its own or if adding personalized text messages and short follow-up sessions (remote online booster sessions) enhances its effectiveness. The trial seeks pregnant women who have recently used alcohol and are willing to use their mobile devices for the study. Participants should reside in Connecticut, Massachusetts, or Michigan and plan to complete their pregnancy. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve maternal health.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the brief alcohol intervention used in this study, known as SBIRT, is generally safe for pregnant women. Studies have found that SBIRT can significantly reduce alcohol use and is well-received by participants.

Early results suggest that the online booster sessions are safe and accepted by participants. These sessions provide additional support to the main program.

The personalized text message support is also considered safe. These messages offer gentle reminders and encouragement to reinforce the main program's goals without any known risks.

Overall, the interventions in this study are designed to be safe and aim to reduce alcohol use during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for alcohol use during pregnancy because they leverage technology to provide support and intervention in a novel way. Unlike traditional methods that might involve in-person counseling or group therapy, these interventions use brief, technology-delivered sessions combined with tailored text messaging and online boosters. This approach allows for more personalized and accessible support, reaching participants through their mobile devices, which can be especially beneficial for pregnant women who may have limited time or access to in-person resources. This innovative delivery method has the potential to enhance engagement and effectiveness in reducing alcohol consumption during pregnancy.

What evidence suggests that this trial's treatments could be effective for reducing alcohol use during pregnancy?

Research has shown that short motivational talks, such as the baseline brief intervention used in this trial, can help pregnant women reduce alcohol consumption. One study found these talks somewhat effective in helping women stop drinking during pregnancy and in preventing early births. In this trial, participants may receive additional support through booster sessions or personalized text messages, which could enhance the intervention's effectiveness. New evidence suggests that technology, like apps or text messages, can improve the delivery of these talks. Overall, these methods appear promising in helping pregnant women reduce or stop drinking alcohol. ^{1 2 4 6 7}

Who Is on the Research Team?

Steven J Ondersma, PhD

Principal Investigator

Michigan State University

Kimberly A Yonkers, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-35, less than 20 weeks along, living in Connecticut, Massachusetts, or Michigan. They must own a mobile device and have reported alcohol use that poses a risk to fetal health. Women not intending to carry the pregnancy to term or unable to communicate in English cannot participate.

Inclusion Criteria

Pregnant

Completion of baseline assessment (enrollment criterion)

20 weeks or less gestation

Exclusion Criteria

Not planning to carry the baby to term

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants complete the baseline assessment and are randomly assigned to a study condition

1 week

1 visit (virtual)

Treatment

Participants receive the MommyCheckup e-SBIRT intervention, with optional booster sessions and tailored text messages

14 weeks

2 booster sessions (virtual), multiple text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment, including nail specimen collection for EtG analysis

20 weeks

4 visits (virtual), 1 nail specimen collection

What Are the Treatments Tested in This Trial?

Interventions

• Baseline brief intervention
• Remote online booster sessions
• SMS

Trial Overview The study tests an app called MommyCheckup designed for pregnant women at risk of alcohol-related issues. It delivers brief interventions and checks if additional booster sessions or personalized text messages can further reduce alcohol consumption during pregnancy.

How Is the Trial Designed?

Group I: General information + SMS Experimental Treatment 2 Interventions

SMS refers to tailored text messaging.

Group II: Baseline brief intervention + SMS Experimental Treatment 2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging

Group III: Baseline brief intervention + 2 booster sessions + SMS Experimental Treatment 3 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\<5 minutes) online boosters using the participants' own mobile device, plus tailored SMS.

Group IV: Baseline brief intervention + 2 booster sessions Experimental Treatment 2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\<5 minutes) online boosters using the participants' own mobile device.

Group V: Baseline brief intervention Experimental Treatment 1 Intervention

Brief technology-delivered intervention for alcohol use during pregnancy

Group VI: General information Placebo Group 1 Intervention

Control

Baseline brief intervention is already approved in United States, European Union for the following indications:

Approved in United States as Brief Intervention for:

• Alcohol use disorder in pregnancy

Approved in European Union as SBIRT for:

• Substance use disorders in pregnancy
• Alcohol use disorder in pregnancy

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Published Research Related to This Trial

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

In a clinical trial involving 864 pregnant women, the Early Start Plus (ESP) intervention, which included a computerized drink-size assessment, showed potential benefits for reducing preterm labor compared to untreated controls.

The Early Start (ES) program, focused on abstention, was associated with lower rates of low birth weight infants compared to controls, indicating that both interventions may help improve maternal and neonatal outcomes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using drink size to talk about drinking during pregnancy: a randomized clinical trial of Early Start Plus. Armstrong, MA., Kaskutas, LA., Witbrodt, J., et al.[2021]

In the first year of implementing the SBIRT approach in an outpatient obstetric clinic, 48.5% of patients completed the 5 P's screening tool, indicating a feasible level of engagement with substance use screening during the perinatal period.

Among the 463 patients who completed the screening, 42% screened positive for substance use, highlighting the importance of universal screening in identifying at-risk individuals and the need for effective referral to treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Insights into Implementation of Universal Screening, Brief Intervention, and Referral to Treatment for Perinatal Substance Use. Reese, SE., Glover, A., Fitch, S., et al.[2023]

The implementation of the SBIRT (Screening, Brief Intervention, and Referral to Treatment) tool into electronic health records (EHR) at three prenatal clinics showed varying performance rates, with the generalist practice achieving an 85% screening rate, indicating effective integration into prenatal care.

Out of 2,619 encounters, only 5.1% of women in the resident clinic reported substance use, highlighting the importance of universal screening in identifying and addressing substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. Hostage, JC., Brock, J., Craig, W., et al.[2022]

The interactive, video-enhanced e-SBI (electronic screening and brief intervention) was found to be highly acceptable among pregnant women, with participants rating it as easy to use and helpful, scoring between 4.7 to 5.0 on a 5-point scale.

The pilot trial suggested medium-sized effects of the e-SBI on achieving 90-day period prevalence abstinence from alcohol and improved pregnancy outcomes, with odds ratios of 3.4 and 3.3 respectively, indicating potential benefits that warrant further investigation in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. Ondersma, SJ., Beatty, JR., Svikis, DS., et al.[2018]

A new bilingual computerized Screening and Brief Intervention (SBI) program for alcohol and sugar-sweetened beverage use was tested with 290 pregnant women, showing high feasibility and acceptability, with 87% completing the program.

The program identified prenatal alcohol use in 21% of participants, significantly higher than the 13% identified through traditional in-person screening, indicating its effectiveness in detecting alcohol use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy. Nayak, MB., Korcha, RA., Kaskutas, LA., et al.[2019]

Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) for pregnant women is crucial to identify those at risk of alcohol consumption, which can harm both maternal and child health.

The study proposes new performance measures to track the screening and intervention rates for alcohol use in prenatal care, aiming to improve the implementation of SBIRT and support pregnant women in reducing alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance measurement: a proposal to increase use of SBIRT and decrease alcohol consumption during pregnancy. O'Brien, PL.[2021]

This study aims to evaluate the effectiveness of a technology-delivered Screening and Brief Intervention (SBI) for pregnant women with unhealthy alcohol use, using a factorial design to assess various intervention strategies.

The primary goal is to measure alcohol abstinence in participants, with secondary outcomes including the impact of tailored text messages and the intervention's effects on birth outcomes, ensuring a comprehensive approach to addressing prenatal alcohol exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. Ondersma, SJ., Todd, L., Jablonski, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05910580

Improving Alcohol and Substance Use Care Access ... The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult ...

2. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05344-8

Effectiveness of brief alcohol interventions for pregnant women BIs are moderately effective in increasing abstinence during pregnancy and preventing preterm birth.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8131659/

Evidence for the Effectiveness and Acceptability of e-SBI or e ... Brief Intervention refers to providing brief motivational messages about the benefits of reducing or abstaining from use and provides the evidence for the ...

4. cdc.gov cdc.gov/mmwr/volumes/72/wr/mm7203a2.htm

Alcohol Use, Screening, and Brief Intervention Among ... 80% of pregnant persons reported being asked about their alcohol use; only 16% of those with past 30-day alcohol consumption were advised by a health care ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10109479/

Screening and Brief Interventions for Alcohol Use During ... Multiple brief intervention sessions reduce patients' alcohol consumption more effectively, increase adherence to drinking guidelines, and ...

6. amchp.org amchp.org/wp-content/uploads/2022/01/AMCHP-NASADAD-SBIRT-Issue-Brief-October-2020.pdf

Screening, Brief Intervention, and Referral to Treatment ( ... One study indicates that while 83 percent of women who use substances achieve abstinence from at least one substance during pregnancy, by three months.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1751485125000030

Did Universal Alcohol Screening and Brief Interventions ... Researchers examining the efficacy of screening, brief intervention, and referral to treatment (SBIRT) found a 38.6% reduction in alcohol use and a 67.7% ...