My Health Coach App RCT

NCT06638463 | Recruiting

• 1 other identifier: STUDY00009709
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline to 12 weeks

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

  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.

  Baseline to 12 weeks

Study Arms (2)

My Health Coach App Group

EXPERIMENTAL

The My Health Coach group receives the My Health Coach app at study start. The My Health Coach app 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.

Behavioral: My Health Coach app

Waitlist Control Group

NO INTERVENTION

The Waitlist Control Group gets access to the My Health Coach app after all the study survey timepoints are complete at 12 weeks.

Interventions

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.

My Health Coach App Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• participated in the past feasibility trial of the My Health Coach app

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14608, United States

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christie L. M. Petrenko, Ph.D.

CONTACT

5852752991; christie_petrenko@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Training, Department of Psychology

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)