Feasibility Study of the My Health Coach App for Adults With FASD

Study Overview
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Brief Summary
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The purpose of this study is to test a new smartphone app for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.

Official Title
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Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)

Conditions
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Fetal Alcohol Spectrum Disorders

Intervention / Treatment
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* Behavioral: My Health Coach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years or older Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure Have conversational fluency in English Own an smartphone Exclusion Criteria: Unable to complete measures or interviews in English Do not have a smartphone Under 18 Do not have an FASD or history or prenatal alcohol exposure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: My Health Coach<br>Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. | Behavioral: My Health Coach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in subjective well-being from baseline to 6-week follow-up on the Personal Well-Being Index - Intellectual Disability Version | The Personal Well-Being Index (PWI) is an 8-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and range from 8 to 40. 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 6 Weeks | 
| Mean change in autonomy ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale | The Basic Psychological Needs Satisfaction and Frustration Scale (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. Each sub-scale has 8 items, with summed scores ranging from 8 to 40. Higher scores reflect higher satisfaction or need being met to a higher degree. The Autonomy sub-scale measures how much a person feels they have choice in what they do in their everyday life. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks | 
| Mean change in competence ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale | The Basic Psychological Needs Satisfaction and Frustration Scale (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. Each sub-scale has 8 items, with summed scores ranging from 8 to 40. Higher scores reflect higher satisfaction or need being met to a higher degree. The Competence sub-scale measures how much a person feels they are successful or do a good job on things in their life. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks | 
| Mean change in relatedness ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale | The Basic Psychological Needs Satisfaction and Frustration Scale (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. Each sub-scale has 8 items, with summed scores ranging from 8 to 40. Higher scores reflect higher satisfaction or need being met to a higher degree. The Relatedness sub-scale measures how much a person feels connected to other people in their life. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks |