Status:
COMPLETED
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Massachusetts, Worcester
Conditions:
Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Eligibility:
FEMALE
18-35 years
Phase:
NA
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 th...
Detailed Description
This factorial trial will include 384 participants. Participants will be pregnant women age 18-35 years who score positive on a frequently used and well-validated screening tool for alcohol use risk i...
Eligibility Criteria
Inclusion
- 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
- 20 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)
Exclusion
- Not planning to carry the baby to term
- Unable to communicate in English
Key Trial Info
Start Date :
May 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT04332172
Start Date
May 19 2023
End Date
August 31 2025
Last Update
October 24 2025
Active Locations (1)
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1
Michigan State University
Flint, Michigan, United States, 48502