Fetal Alcohol Spectrum Disorders Clinical Trial
— e-HealthOfficial title:
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
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.
Status | Recruiting |
Enrollment | 384 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michigan State University | Flint | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University | National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Massachusetts, Worcester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants abstinent from alcohol as measured by Timeline FollowBack Calendar Recall and Ethyl Glucuronide (EtG) | The primary outcome of abstinence will be defined as no self-report of alcohol use in the past 90 days via Timeline FollowBack, and no evidence of use via EtG. The Timeline FollowBack will be administered at 34 weeks gestation and biospecimens for EtG are collected at approximately 37 weeks gestation (36 weeks for fingernails; 38 weeks for toenails). | 90 days | |
Secondary | Number of participants with a healthy birth outcome (full-term live birth of normal birthweight, with no days in NICU) | Healthy birth outcome, using birth outcome data from the state of birth, is defined as a full-term live birth (>=36 weeks + 6 days) of normal birthweight (>2500 gms) and with no days in neonatal intensive care. | Entire period of gestation |
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