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

384 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to find out if pregnant women screening positive for alcohol risk like the brief alcohol intervention application that the investigators have developed (called the MommyCheckup, which is a technology-delivered SBIRT, or e-SBIRT), and if it helps them to reduce alcohol use. The investigators also wish to test whether e-SBIRT effects can be enhanced by booster sessions and/or tailored text messages.

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 data supports the effectiveness of the treatment e-Intervention for Alcohol Use in Pregnancy?

Research suggests that Screening, Brief Intervention, and Referral to Treatment (SBIRT) can help identify and reduce alcohol use in pregnant women, which is crucial for preventing negative health outcomes for both mother and child. Additionally, computerized and electronic versions of these interventions have been found feasible and acceptable, potentially improving implementation in prenatal care settings. ^{1 2 3 4 5}

Is the e-Intervention for Alcohol Use in Pregnancy safe for humans?

The studies suggest that electronic Screening and Brief Intervention (e-SBI) for alcohol use in pregnancy is generally safe and well-accepted by participants. These interventions are designed to help reduce alcohol consumption during pregnancy, which is important for maternal and child health. ^{1 2 3 5 6}

How is the e-Intervention for Alcohol Use in Pregnancy treatment different from other treatments?

The e-Intervention for Alcohol Use in Pregnancy is unique because it uses a computer-delivered approach to provide screening and brief intervention (SBI) for alcohol use, which is enhanced with interactive and empathic video content. This method is designed to be more accessible and feasible, especially in settings with high patient loads and limited resources, compared to traditional in-person interventions. ^{1 3 6 7 8}

Research Team

Steven J Ondersma, PhD

Principal Investigator

Michigan State University

Kimberly A Yonkers, MD

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

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

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

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

Using drink size to talk about drinking during pregnancy: a randomized clinical trial of Early Start Plus. [2021]

3. England 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. [2019]

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

Early Insights into Implementation of Universal Screening, Brief Intervention, and Referral to Treatment for Perinatal Substance Use. [2023]

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

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. [2018]

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

Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. [2018]