N/A
N=43
Feasibility Study of the My Health Coach App for Adults With FASD
Fetal Alcohol Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT05604014 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version — 3.51; 3.59 units on a scale — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- My Health Coach (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version |
3.51; 3.59 | 0.49 |
| 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 |
3.38; 3.46 | 0.5 |
| PRIMARY Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale |
3.12; 3.32 | 0.16 |
| PRIMARY Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale |
3.48; 3.58 | 0.44 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05604014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.