Randomized Controlled Trial of the My Health Coach App for Adults With Fetal Alcohol

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are: Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life? All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete. Researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adult 18 years or older

• have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure

• have sufficient fluency in written English

• own a smartphone

Locations
United States
New York
University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Christie L. M. Petrenko, Ph.D.
christie_petrenko@urmc.rochester.edu
5852752991
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Experimental: My Health Coach App Group
The My Health Coach group receives the My Health Coach app at study start. The My Health Coach app is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.
No_intervention: Waitlist Control Group
The Waitlist Control Group gets access to the My Health Coach app after all the study survey timepoints are complete at 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov