COMPLETED

Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy

Quick Facts

Study Start:2023-05-19
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04332172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-35 years
  2. * Pregnant
  3. * 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
  4. * 20 weeks or less gestation
  5. * Planning to give birth in either Connecticut, Massachusetts, or Michigan
  6. * 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
  7. * Completion of baseline assessment (enrollment criterion)
  1. * Not planning to carry the baby to term
  2. * Unable to communicate in English

Contacts and Locations

Principal Investigator

Steven J Ondersma, PhD
PRINCIPAL_INVESTIGATOR
Michigan State University
Kimberly A Yonkers, MD
PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester

Study Locations (Sites)

Michigan State University
Flint, Michigan, 48502
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Steven J Ondersma, PhD, PRINCIPAL_INVESTIGATOR, Michigan State University
  • Kimberly A Yonkers, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-19
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-05-19
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Fetal Alcohol Spectrum Disorders
  • Fetal Alcohol Syndrome
  • Fetal Alcohol Effect