NCT05277194Completed
Reducing Challenging Behaviors in Children With Autism Through Digital Health
Investigating the Impact of an Emotional Stress Alarm App (KeepCalm) on Managing Stress and Preventing Challenging Behaviors in Children With Autism
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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) it is challenging to implement evidence-based, personalized strategies for individual children, and; 3) it is difficult for teachers to track which strategies are successful for individual children. The investigators' personalized mobile-health emotion regulation application (m-health app) will pair heart rate tracking with digital tools to help reduce challenging behavior by supporting stress detection, reminding teachers of specific behavioral strategies and helping teachers to track progress.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 4 Feb 2022
- Start date
- 26 Sept 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- University of Pennsylvania
- Diseases
- Autism
- NCT number
- NCT05277194
What you commit to
- Study type: Interventional
- Participants enrolled: 92
- From 26 Sept 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Child does not exhibit challenging behaviors
Who the study is looking for
- 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
Age in the registry: 3 years to 13 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.