My Health Coach App for Adults with Fetal Alcohol Spectrum Disorders

This study is testing if the My Health Coach app can help adults with Fetal Alcohol Spectrum Disorders (FASD) improve their quality of life and manage daily activities. The app is a self-guided mobile tool designed to support well-being. To join, you must be an adult aged 18 or older with FASD or a history of prenatal alcohol exposure, be fluent in written English, and own a smartphone. You cannot have participated in a previous trial of this app. Researchers will measure success by looking at changes in your personal well-being and how well your basic psychological needs are met over 12 weeks. The current status of this study is unclear.

Study design
This is a randomized controlled trial with 200 participants. Half will receive the My Health Coach app at the start, and the other half will receive it after 12 weeks.
What's involved
You will complete three sets of surveys: at the start, at 6 weeks, and at 12 weeks. If you are in the wait-list group, you will receive the app after the 12-week surveys.
Compensation
Not stated in the trial record.
Follow-up
Your well-being and psychological needs will be measured up to 12 weeks after the study starts.

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NCT06638463

My Health Coach App RCT

Recruiting
NAAges 18+InterventionalTreatment
University of Rochester
~200 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:My Health Coach app

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean effect size on the Personal Well-being Index - Intellectual Disability Version (complemented by statistical hypothesis testing and 95% CI)
Measured over Baseline to 12 weeks
+1 more outcome measured
Fetal Alcohol Spectrum Disorders
1 sites across 1 states
New York1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

participated in the past feasibility trial of the My Health Coach app
  • Mean effect size on the Personal Well-being Index - Intellectual Disability Version (complemented by statistical hypothesis testing and 95% CI)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.

  • Mean effect size on The Basic Psychological Need Satisfaction and Frustration Scale (complemented by statistical hypothesis testing and 95% CI)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.