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NCT05277194 · ClinicalTrials.gov registry record · NA
Reducing Challenging Behaviors in Children With Autism Through Digital Health
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 87
- Enrollment target
NCT05277194: Completed NA study, sponsored by University of Pennsylvania.
NCT05277194 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 87 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05277194, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 87 participants
- Enrollment target
Study 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) 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.
Primary Outcome
The System Usability Scale (SUS) measures perceptions of usability of a given system, in this case, the KeepCalm app. The scale consists of 10 items, each rated on a 5-point Likert Scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Responses are transformed to get a total range of possible values from 0-100, with higher scores indicating higher perceptions of usability. Typically, a score above 68 is regarded as a good score.
Interventions
- BEHAVIORAL KeepCalm app
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2023-09-26 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
What the finished NCT05277194 record still lists
NCT05277194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which KeepCalm app is the first listed.
NCT05277194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05277194 about?
NCT05277194 is a clinical study titled "Reducing Challenging Behaviors in Children With Autism Through Digital Health". 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, an...
What is the current status of trial NCT05277194?
This trial is currently completed. It is a NA study. The enrollment target is 87 participants. The study started on 2023-09-26. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT05277194?
The interventions under investigation include: KeepCalm app (BEHAVIORAL).
Who is sponsoring clinical trial NCT05277194?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05277194's enrollment target sits among peer trials
87 974th of 2000 higher than 1,025 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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