Recruiting

My Health Coach

Sponsor:

University of Rochester

Code:

NCT06638463

Conditions

Fetal Alcohol Spectrum Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

My Health Coach app

Study Details

Brief 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.

Conditions

Fetal Alcohol Spectrum Disorders

Study ID

NCT06638463

Start date

Apr 1, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • participated in the past feasibility trial of the My Health Coach app

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

My Health Coach app

My Health Coach 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.

Primary outcome measure

  • Mean effect size on the Personal Well-being Index - Intellectual Disability Version (complemented by statistical hypothesis testing and 95% CI) [ Time Frame: Baseline to 12 weeks ]
  • Mean effect size on The Basic Psychological Need Satisfaction and Frustration Scale (complemented by statistical hypothesis testing and 95% CI) [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Christie L. M. Petrenko, Ph.D.

5852752991christie_petrenko@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14608

Contacts

Christie L. M. Petrenko, Ph.D.

585-275-2991christie_petrenko@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-02-18.