Clinical trial NCT06638463: My Health Coach App RCT
Official title: Randomized Controlled Trial of the My Health Coach App for Adults With Fetal Alcohol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This trial involves a 2-arm randomized controlled trial. Participants will be randomized (50:50 allocation) into the (1) My Health Coach group, or the (2) Wait-list Control group. The My Health Coach app is designed to support the quality of life of adults with FASD by providing tools to help with self-management, advocacy, health literacy, use of supports, and engagement in meaningful activities.

This study is designed to: (1) evaluate the efficacy of the My Health Coach app with adults with FASD, (2) test whether changes in competence, autonomy, and/or relatedness mediate intervention outcomes on reported quality of life, and (3) identify app usage patterns that relate to greater outcome improvement. Primary outcomes include perceived well-being, the degree to which basic psychological needs of competence, autonomy, and relatedness are met, and readiness for self-management. We are also interested in participants' perceptions of app quality and patterns of app usage.

All participants will complete the study assessment battery measuring these outcomes at baseline (T1), 6 weeks (T2), and 12 weeks (T3). Wait-list participants will receive the app after T3.

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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: