Status:
COMPLETED
Reducing Challenging Behaviors in Children With Autism Through Digital Health
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Alevio LLC
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-13 years
Phase:
NA
Brief Summary
School-based behavioral approaches to managing challenging behaviors in children with ASD are limited by three key factors: 1) children with ASD often have difficulties communicating their emotions; 2...
Detailed Description
The project will develop and pilot test a personalized medicine mobile health emotion regulation application (the m-health KeepCalm app) that incorporates physiological stress measurement to support e...
Eligibility Criteria
Inclusion
- Preschool or elementary school child with autism along with a parent and teacher and/or classroom aide
- Child must have challenging behaviors including but not limited to aggression, escape behavior, loud noises, non-compliance, property destruction, rigid/inflexible behavior, self-injury, and transition difficulties
- Adult participants must have access to an iPhone in order to test the app or be willing to use a provided study iPhone
Exclusion
- Child does not exhibit challenging behaviors
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT05277194
Start Date
September 26 2023
End Date
June 30 2025
Last Update
July 25 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19146