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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604014
• Other study ID #: 00007749
• Secondary ID: UH2AA029050
• Status: Completed
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Behavioral:
• My Health Coach
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.

Locations

Country	Name	City	State
United States	Mt. Hope Family Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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