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NCT Number: NCT06638463

My Health Coach App RCT

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.

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Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14608, United States

Location status: Recruiting

Location contact

Christie L. M. Petrenko, Ph.D.

CONTACT

[email protected]

585-275-2991

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Health Coach app

Behavioral

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 outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christie L. M. Petrenko, Ph.D.

CONTACT

[email protected]

5852752991 ext. 241

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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