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Recruiting NCT06638463

NCT06638463 My Health Coach App RCT

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Clinical Trial Summary
NCT ID NCT06638463
Status Recruiting
Phase
Sponsor University of Rochester
Condition Fetal Alcohol Spectrum Disorders
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2025-04-01
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
My Health Coach app

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Christie L. M. Petrenko, Ph.D.

✉ christie_petrenko@urmc.rochester.edu

📞 5852752991

Frequently Asked Questions

Who can join the NCT06638463 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Fetal Alcohol Spectrum Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06638463 currently recruiting?

Yes, NCT06638463 is actively recruiting participants. Contact the research team at christie_petrenko@urmc.rochester.edu for enrollment information.

Where is the NCT06638463 trial being conducted?

This trial is being conducted at Rochester, United States.

Who is sponsoring the NCT06638463 clinical trial?

NCT06638463 is sponsored by University of Rochester. The trial plans to enroll 200 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology