Feasibility Study of the My Health Coach App for Adults With FASD
Primary Purpose
Fetal Alcohol Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Health Coach
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders
Eligibility Criteria
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
Sites / Locations
- Mt. Hope Family Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
My Health Coach
Arm Description
Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05604014
First Posted
October 28, 2022
Last Updated
October 13, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05604014
Brief Title
Feasibility Study of the My Health Coach App for Adults With FASD
Official Title
Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
My Health Coach
Arm Type
Experimental
Arm Description
Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
My Health Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in subjective well-being from baseline to 6-week follow-up on the Personal Well-Being Index - Intellectual Disability Version
Description
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.
Time Frame
Baseline to 6 Weeks
Title
Mean change in autonomy ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale
Description
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.
Time Frame
Baseline to 6 Weeks
Title
Mean change in competence ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale
Description
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.
Time Frame
Baseline to 6 Weeks
Title
Mean change in relatedness ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale
Description
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.
Time Frame
Baseline to 6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mt. Hope Family Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14608
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be deposited within the Collaborative Initiative on FASD (CIFASD) Central Repository and the National Institute on Alcohol Abuse and Alcoholism Data Archive as required by grant regulations. CIFASD Data Sharing policies and data access request information can be found at: https://cifasd.org/data-sharing/. NIAAA-DA access can be found at: https://nda.nih.gov/niaaa/
IPD Sharing Time Frame
All collection data are shared automatically two years after the grant end date.
IPD Sharing Access Criteria
See https://nda.nih.gov/niaaa/ for details.
IPD Sharing URL
https://nda.nih.gov/niaaa/
Learn more about this trial
Feasibility Study of the My Health Coach App for Adults With FASD
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