RecruitingNot Applicable

My Health Coach App RCT

United States200 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean effect size on the Personal Well-being Index - Intellectual Disability Version (complemented by statistical hypothesis testing and 95% CI)

Timeframe: Baseline to 12 weeks

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

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT06638463

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Christie L. M. Petrenko, Ph.D.

5852752991 christie_petrenko@urmc.rochester.edu

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean effect size on the Personal Well-being Index - Intellectual Disability Version (complemented by statistical hypothesis testing and 95% CI)

Timeframe: Baseline to 12 weeks

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

Timeframe: Baseline to 12 weeks