My Health Coach App RCT

February 13, 2026 updated by: Christie Petrenko, University of Rochester

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial involves a 2-arm randomized controlled trial. Participants will be randomized (50:50 allocation) into the (1) My Health Coach group, or the (2) Wait-list Control group. The My Health Coach app is designed to support the quality of life of adults with FASD by providing tools to help with self-management, advocacy, health literacy, use of supports, and engagement in meaningful activities.

This study is designed to: (1) evaluate the efficacy of the My Health Coach app with adults with FASD, (2) test whether changes in competence, autonomy, and/or relatedness mediate intervention outcomes on reported quality of life, and (3) identify app usage patterns that relate to greater outcome improvement. Primary outcomes include perceived well-being, the degree to which basic psychological needs of competence, autonomy, and relatedness are met, and readiness for self-management. We are also interested in participants' perceptions of app quality and patterns of app usage.

All participants will complete the study assessment battery measuring these outcomes at baseline (T1), 6 weeks (T2), and 12 weeks (T3). Wait-list participants will receive the app after T3.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The PWI is an 8-item measure of subjective wellbeing. The Intellectual Disability Version uses more concrete item wording and a 5-point pictoral scale. Ratings are summed and higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium, and 0.8 is large.
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
The BPNSF is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Higher scores reflect higher satisfaction or need being met to a higher degree. An effect size of 0.2 is small, 0.5 is medium, and 0.8 is large.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

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 Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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