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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Intervention Measure (AIM)

Feasibility of Intervention Measure (FIM)

Intervention Appropriateness Measure (IAM)

+2 more

Secondary outcome measures

Emotion Dysregulation Inventory (EDI)

Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS)

School Situations Questionnaire (SSQ)

Other outcome measures

Artifact removal

Clinical decision support success

False positives/negatives

+1 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,267 Total Patients Enrolled

15 Trials studying Autism Spectrum Disorder

4,547 Patients Enrolled for Autism Spectrum Disorder

Alevio LLCUNKNOWN

Alevio Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this medical experiment?

"Affirmative. Per the data posted on clinicaltrials.gov, this medical trial is presently open to applicants as of November 21st 2023; it was originally published in September 26th 2023. Specifically, they are looking for 20 individuals at a single site for participation."

Answered by AI

Do seniors meet the qualifications for participating in this scientific research?

"In accordance with the outlined criteria for this experiment, 3 is the lowest age at which a participant may take part and 13 is the highest."

Answered by AI

Is recruitment for this experiment still ongoing?

"Affirmative, according to the data hosted on clinicaltrials.gov this experiment is recruiting participants. It was initially published on September 26th 2023 and has most recently been updated November 21st 2023. For now, a total of twenty patients must be enrolled from one medical facility."

Answered by AI

To what demographic is this research project open?

"This research is looking for 20 volunteers with autism spectrum disorder, aged 3 to 13. To be eligible, a preschooler/elementary school student must have an accompanying parent and teacher/classroom aide; furthermore they need to exhibit difficult behaviors such as aggression, escape attempts, self-injury and others. Additionally, adult participants should either own an iPhone or agree to use one provided by the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Challenging Behaviors in Children With Autism Through Digital Health

2023. "Reducing Challenging Behaviors in Children With Autism Through Digital Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05277194.

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