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Digital Health
Digital Health App for Autism
N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a personalized m-health app to help teachers manage challenging behaviors in children with ASD. It will track heart rate & provide strategies & progress tracking.
Who is the study for?
This trial is for preschool or elementary school children with autism who exhibit challenging behaviors such as aggression, non-compliance, and self-injury. A parent and teacher or aide must participate, and they need access to an iPhone to use the KeepCalm app.
What is being tested?
The trial tests the KeepCalm app designed for children with autism. The app pairs heart rate tracking with digital tools to help manage stress and challenging behaviors by assisting teachers in implementing personalized strategies and tracking progress.
What are the potential side effects?
Since this intervention involves a digital health application rather than medication, traditional side effects are not expected. However, there may be indirect effects related to device usage like increased screen time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Intervention Measure (AIM)
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measure (IAM)
+2 moreSecondary study objectives
Emotion Dysregulation Inventory (EDI)
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS)
School Situations Questionnaire (SSQ)
Other study objectives
Artifact removal
Clinical decision support success
False positives/negatives
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: KeepCalm AppExperimental Treatment1 Intervention
The KeepCalm app is designed to help manage stress and prevent challenging behaviors in children with autism. The app uses physiological stress tracking, assessed using heart rate monitoring, to indicate when challenging behaviors are likely to occur. The app then recommends strategies to help prevent the onset of challenging behaviors. The app can also be used to track trends in triggers, behaviors, and strategies, and to communicate this information to parents and other members of a child's educational team.
Group II: Waitlist ControlActive Control1 Intervention
Individuals assigned to the waitlist control condition will gain access to the KeepCalm app following the study's completion. During the trial, they will not receive any intervention, but will complete baseline and post-intervention measures during the trial.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,727,028 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,547 Patients Enrolled for Autism Spectrum Disorder
Alevio LLCUNKNOWN
Alevio Inc.UNKNOWN