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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

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

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 more

Secondary 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 more

Awards & 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.

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