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

Sponsor
University of Rochester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05604014
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
48
1
1
3.9
12.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: My Health Coach
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: My Health Coach

Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks.

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.

Outcome Measures

Primary Outcome Measures

  1. Mean change in subjective well-being from baseline to 6-week follow-up on the Personal Well-Being Index - Intellectual Disability Version [Baseline to 6 Weeks]

    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.

  2. Mean change in autonomy ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale [Baseline to 6 Weeks]

    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.

  3. Mean change in competence ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale [Baseline to 6 Weeks]

    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.

  4. Mean change in relatedness ratings from baseline to 6-week follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy sub-scale [Baseline to 6 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mt. Hope Family Center Rochester New York United States 14608

Sponsors and Collaborators

  • University of Rochester
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christie Petrenko, Research Associate Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT05604014
Other Study ID Numbers:
  • 00007749
  • UH2AA029050
First Posted:
Nov 3, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2022