Trial Outcomes & Findings for Feasibility Study of the My Health Coach App for Adults With FASD (NCT NCT05604014)

Last Updated: 2024-10-04

Results Overview

The Personal Well-Being Index (PWI) is an 7-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are averaged and the mean total is reported ranging from 1 to 5. Higher scores reflect better perceived well-being.

Recruitment status

COMPLETED

Study phase

Target enrollment

95 participants

Primary outcome timeframe

Baseline to 6 Weeks

Results posted on

2024-10-04

Participant Flow

Of the 95 enrolled in the study, 52 were excluded for the following reasons: 2 did not meet eligibility criteria, 1 declined to participate, 5 had incomplete screening data, 7 were duplicates, and 37 were suspected fraudulent participants.

Participant milestones

Participant milestones
Measure	My Health Coach Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Overall Study STARTED	43
Overall Study Baseline Surveys	39
Overall Study Installed App	33
Overall Study 6-Week Follow-up Surveys	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	My Health Coach Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Overall Study Lost to Follow-up	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	My Health Coach n=43 Participants Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Age, Continuous	28.1 years STANDARD_DEVIATION 11.19 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants
Region of Enrollment Canada	7 Participants n=5 Participants
Region of Enrollment Netherlands	4 Participants n=5 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants
Region of Enrollment Ireland	1 Participants n=5 Participants
Region of Enrollment Italy	1 Participants n=5 Participants
Region of Enrollment New Zealand	1 Participants n=5 Participants
Region of Enrollment South Africa	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 Weeks

Population: Participants with complete data at baseline and 6-week follow-up surveys are included.

Outcome measures

Outcome measures
Measure	My Health Coach n=30 Participants Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version Baseline	3.51 units on a scale Standard Deviation 0.68
Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version 6-Week Follow-up	3.59 units on a scale Standard Deviation 0.69

PRIMARY outcome

Timeframe: Baseline to 6 Weeks

Population: Participants with completed data at both baseline and 6-week follow-up timepoints were included.

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. Scores were averaged across items with reported mean ranging from 1 to 5. 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.

Outcome measures

Outcome measures
Measure	My Health Coach n=28 Participants Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
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	3.38 units on a scale Standard Deviation 0.59
Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale 6-Week follow-up	3.46 units on a scale Standard Deviation 0.49

PRIMARY outcome

Timeframe: Baseline to 6 Weeks

Population: Participants with complete data at both baseline and 6-week follow-up timepoints were included.

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. Scores were averaged across items with reported mean ranging from 1 to 5. 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.

Outcome measures

Outcome measures
Measure	My Health Coach n=28 Participants Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale Baseline	3.12 units on a scale Standard Deviation 0.67
Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale 6-week follow-up	3.32 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline to 6 Weeks

Population: Participants with completed data at both baseline and 6-week follow-up timepoints were included.

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. Scores were averaged across items with reported mean ranging from 1 to 5. 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.

Outcome measures

Outcome measures
Measure	My Health Coach n=28 Participants Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. 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.
Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale Baseline	3.48 units on a scale Standard Deviation 0.69
Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale 6-week Follow-up	3.58 units on a scale Standard Deviation 0.58

Adverse Events

My Health Coach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christie L. M. Petrenko, Ph.D.

Mt. Hope Family Center, University of Rochester

Phone: 5852752991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place