e-Intervention for Alcohol Use in Pregnancy
(e-Health Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Michigan State University
Disqualifiers: Not carrying to term, others
Approved in 2 Jurisdictions
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.
12345Is 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.
12356How 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.
13678Eligibility 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
+4 more
Exclusion Criteria
Not planning to carry the baby to term
I cannot communicate in English.
Trial 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
Participant Groups
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.
6Treatment groups
Experimental Treatment
Placebo Group
Group I: General information + SMSExperimental Treatment2 Interventions
SMS refers to tailored text messaging.
Group II: Baseline brief intervention + SMSExperimental Treatment2 Interventions
Brief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging
Group III: Baseline brief intervention + 2 booster sessions + SMSExperimental Treatment3 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 sessionsExperimental Treatment2 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 interventionExperimental Treatment1 Intervention
Brief technology-delivered intervention for alcohol use during pregnancy
Group VI: General informationPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michigan State UniversityFlint, MI
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Who Is Running the Clinical Trial?
Michigan State UniversityLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
University of Massachusetts, WorcesterCollaborator
References
Performance measurement: a proposal to increase use of SBIRT and decrease alcohol consumption during pregnancy. [2021]Alcohol consumption during pregnancy has negative implications for maternal and child health. Appropriate early universal Screening, Brief Intervention and Referral to Treatment (SBIRT) for pregnant women is necessary to identify women at risk and reduce the likelihood of continued drinking. Because SBIRT is not consistently used, the development and use of performance measures to assure implementation of SBIRT are key steps towards intervention and reduction of alcohol consumption during pregnancy. Practice guidelines provide ample support for specific instruments designed for SBIRT in prenatal care. An examination of existing performance measures related to alcohol consumption during pregnancy, however, reveals no comprehensive published performance measure designed to quantify the use of SBIRT for alcohol use in prenatal care. Process performance measures were developed that can determine the proportion of pregnant women who are screened during the course of prenatal care and the proportion of women requiring either brief intervention or referral to substance use disorder treatment who received those interventions. The measures require use of screening instruments validated for use with pregnant women. The two proposed measures would represent a significant step in efforts to assure appropriate intervention for women who drink during pregnancy, hold accountable providers who do not employ SBIRT, and provide a basis from which necessary systemic changes might occur. Pregnancy is a time when many women are motivated to stop drinking. That opportunity should be seized, with timely intervention offering assistance for pregnant women who have not stopped drinking of their own accord.
Using drink size to talk about drinking during pregnancy: a randomized clinical trial of Early Start Plus. [2021]This clinical trial compared two brief alcohol use interventions in prenatal clinics: Early Start (ES), a substance-abuse screening and treatment program integrated with prenatal care focused on abstention (n=298), and Early Start Plus (ESP), adding a computerized drink-size assessment tool and intervention focused on drinking less (n=266). Controls were untreated alcohol users (n=344). Controls had higher adverse neonatal and maternal outcome rates. Findings favored ESP for preterm labor and ES for low birth weight. No differences between ES and ESP were statistically significant. ESP provides clinicians with an innovative assessment tool that creates open dialogue about drinking during pregnancy.
Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy. [2019]Recommended screening and brief intervention (SBI) for alcohol use during pregnancy is impeded by high patient loads and limited resources in public health settings. We evaluated the feasibility, acceptability and validity of a new self-administered, single-session, bilingual, computerized Screening and Brief Intervention (SBI) program for alcohol and sugar sweetened beverage (SSB) use in pregnancy.
Early Insights into Implementation of Universal Screening, Brief Intervention, and Referral to Treatment for Perinatal Substance Use. [2023]Perinatal substance use is a growing concern across the United States. Universal screening, brief intervention, and referral to treatment (SBIRT) is one systems-level approach to addressing perinatal substance use. The objective of this study is to assess early efforts to implement SBIRT in an outpatient obstetric clinic.
Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. [2023]Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial.
Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. [2018]Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus 3 tailored mailings, and estimated intervention effects.
Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. [2022]Universal screening for substance use during pregnancy, brief intervention, and referral to treatment (SBIRT) is recommended by ACOG and the USPSTF. Here we present the implementation of SBIRT into the electronic health record (EHR) to inform clinical intervention and collect data on the prevalence of substance use during pregnancy at three prenatal clinics.
The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. [2018]Screening, brief intervention, and referral to treatment (SBIRT) is effective for reducing risky alcohol use across a variety of medical settings. However, most programs have been unsustainable because of cost and time demands. Telehealth may alleviate on-site clinician burden. This exploratory study examines the feasibility of a new Remote Brief Intervention and Referral to Treatment (R-BIRT) model.