Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
e-Health
1 other identifier
interventional
384
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedOctober 24, 2025
October 1, 2025
2.2 years
March 25, 2020
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants abstinent from alcohol as measured by Timeline FollowBack Calendar Recall
The primary outcome of abstinence will be defined as no self-report of alcohol use in the past 90 days via Timeline FollowBack.
90 days
Secondary Outcomes (1)
Number of participants with a healthy birth outcome (full-term live birth of normal birthweight, with no days in NICU)
Entire period of gestation
Study Arms (6)
General information
PLACEBO COMPARATORControl
General information + SMS
EXPERIMENTALSMS refers to tailored text messaging.
Baseline brief intervention
EXPERIMENTALBrief technology-delivered intervention for alcohol use during pregnancy
Baseline brief intervention + SMS
EXPERIMENTALBrief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging
Baseline brief intervention + 2 booster sessions
EXPERIMENTALBrief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\<5 minutes) online boosters using the participants' own mobile device.
Baseline brief intervention + 2 booster sessions + SMS
EXPERIMENTALBrief 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.
Interventions
General information related to pregnancy is provided electronically.
Interactive brief motivational intervention is delivered electronically. Provides an introduction, describing the purpose and duration, emphasizing the non-judgmental nature of the brief intervention (BI). Uses a high-quality video featuring gain-framed messaging, quit recommendation, and testimonial from a race-matched woman; tailored on race-ethnicity, efficacy, binge frequency, and level of concern regarding her own alcohol use. The e-BI poses a question regarding the participant's willingness to avoid alcohol throughout her pregnancy. Responses to this question will sort participants into one of three major branches, each using motivational principles to promote alcohol abstinence during pregnancy.
Two \< 5-minute online e-BI boosters will be sent to participants via text link (one at 6 weeks post-baseline and one at 30 weeks gestation). The boosters will include a brief summary of the prior session in terms of the participant's concerns and goals. It will also include an assessment of her current status regarding (a) use of alcohol, and (b) intentions regarding future use of alcohol. A brief (1-2 minute) video tailored on her current status and prior goal will be provided. Finally, the boosters will contain optional goal-setting regarding reaching or maintaining abstinence.
Tailored text messages (SMS) will be sent to participants twice a week from baseline throughout her pregnancy (or until she opts out). The messages will be tailored on her quit status, goals, efficacy, level of concern, gestation, and perceived advantages of change. Messages will follow current state of the art regarding messaging preferences, tailoring, and gain-framing. The current list includes messages regarding fetal development, nutrition, exercise, and stress management, as well as alcohol.
Eligibility Criteria
You may qualify if:
- Age 18-35 years
- Pregnant
- Self-report of alcohol risk (those who score positive on the T-ACE screen (Sokol, Martier, \& Ager, 1989), and also report either drinking weekly or more in the past month, or having 4 or more drinks at a time at least monthly in the 12 months before becoming pregnant
- weeks or less gestation
- Planning to give birth in either Connecticut, Massachusetts, or Michigan
- Owning a mobile device that they are willing to use to receive study-related text reminders and to complete online study activities including assessments/boosters
- Completion of baseline assessment (enrollment criterion)
You may not qualify if:
- Not planning to carry the baby to term
- Unable to communicate in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michigan State University
Flint, Michigan, 48502, United States
Related Publications (1)
Ondersma SJ, Todd L, Jablonski S, Ahuja C, Gilstad-Hayden K, Goyert G, Loree A, Heffner J, Yonkers KA. Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. BMJ Open. 2022 Aug 3;12(8):e062735. doi: 10.1136/bmjopen-2022-062735.
PMID: 35922101DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Ondersma, PhD
Michigan State University
- PRINCIPAL INVESTIGATOR
Kimberly A Yonkers, MD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants will be randomly assigned to a study condition during the baseline assessment by the study software and the assigned condition content will be provided directly to the participant rather than by study staff. The staff member who enrolls the participant will not have access to the assigned condition/content, which will aid in blinding study staff. The biostatistician and data analyst will be blinded for all hypothesis-testing analyses by coding experimental condition with a non-identifying number, the table for which will be maintained at the PI's office.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and PI
Study Record Dates
First Submitted
March 25, 2020
First Posted
April 2, 2020
Study Start
May 19, 2023
Primary Completion
August 6, 2025
Study Completion
August 31, 2025
Last Updated
October 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- In accordance with the Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) \[2nd Revision\], Notice Number NOT-AA-19-020, released July 31, 2019: Data will be shared with the general research community 2 years after the grant end date on the initial Notice of Award. However, if a manuscript using study data is accepted for publication prior to the 2-year embargo, the study data specifically used in that manuscript will be shared with the general research community at the time of publication. For this study, the grant end date is August 31, 2024, making the share date August 31, 2026 unless publication occurs prior to that date, in which case published data will be shared at the time of publication. The data are expected to remain available indefinitely unless sharing is limited by currently unforeseen circumstances.
- Access Criteria
- Access to data for research purposes will be provided through the National Data Archive Data Access Committee (NDA DAC). Investigators and institutions seeking data from the NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is co-signed by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA). The procedures associated with data access are described at https://ndar.nih.gov/ndarpublicweb/policies.go#sop4
Data will be deposited in the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAA DA). All collected Individual Participant Data (IPD) at the item level and individual subject level will be shared. The data will be identified only by Global Unique Identifier (GUID; no personally identifiable information will be shared).