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NCT06638463 · ClinicalTrials.gov registry record · NA
My Health Coach App RCT
A NA study of Fetal Alcohol Spectrum Disorders, sponsored by University of Rochester.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06638463: Recruiting NA study of Fetal Alcohol Spectrum Disorders, sponsored by University of Rochester.
NCT06638463 is a NA study of Fetal Alcohol Spectrum Disorders that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 200 participants, above the 86-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (133% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06638463, a NA study of Fetal Alcohol Spectrum Disorders, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL My Health Coach app
Study Locations (1)
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06638463 shows while recruiting
NCT06638463 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (133% higher).
The record links to 1 condition, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 1 intervention - of which My Health Coach app is the first listed.
NCT06638463 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06638463 about?
NCT06638463 is a clinical study titled "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 FAS...
What is the current status of trial NCT06638463?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2025-04-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06638463 study?
This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders.
What interventions are being tested in trial NCT06638463?
The interventions under investigation include: My Health Coach app (BEHAVIORAL).
Who is sponsoring clinical trial NCT06638463?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06638463 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fetal Alcohol Spectrum Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06638463's enrollment target sits among peer trials
200 2nd of 10 higher than 8 of 10 other Fetal Alcohol Spectrum Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fetal Alcohol Spectrum Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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