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Completed
NCT04332172
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
Conditions: Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Fetal Alcohol Effect
Sex: Female
Ages: 18 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 384
Sponsor: Michigan State University
Location: Michigan State University Flint Michigan
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Not planning to carry the baby to term
* Unable to communicate in English
Source: ClinicalTrials.gov (NCT04332172). StuddyBuddy aggregates publicly available trial information.