Reducing Challenging Behaviors in Children With Autism Through Digital Health

NCT05277194 | Completed

• 1 other identifier: 829690
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

emotion regulation; digital mental health; preschool; elementary school; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (5)

• System Usability Scale (SUS)

  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.

  3 months post-baseline

• Acceptability of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (AIM) is used to measure the acceptability of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater acceptability of the intervention.

  3 months post-baseline

• Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) is used to measure the feasibility of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater feasibility of the intervention.

  3 months post-baseline

• Intervention Appropriateness Measure (IAM)

  The Intervention Appropriateness Measure (IAM) is used to measure the appropriateness of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater appropriateness of the intervention.

  3 months post-baseline

• Qualitative interview

  This interview will assess the intervention's usability, appropriateness, feasibility, and acceptability in a qualitative interview format.

  3 months post-baseline

Secondary Outcomes (3)

• School Situations Questionnaire (SSQ)

  baseline and 3 months post-baseline

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

  baseline and 3 months post-baseline

• Emotion Dysregulation Inventory (EDI)

  baseline and 3 months post-baseline

Other Outcomes (4)

• Artifact removal

  through study participation, an average of 3 months

• Offline mode activations

  through study participation, an average of 3 months

• Clinical decision support success

  through study participation, an average of 3 months

Study Arms (2)

KeepCalm App

EXPERIMENTAL

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.

Behavioral: KeepCalm app

Waitlist Control

NO 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.

Interventions

KeepCalm app BEHAVIORAL

The KeepCalm app is designed to help manage stress and prevent challenging behaviors in children with autism.

KeepCalm App

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Child does not exhibit challenging behaviors

Sponsors & Collaborators

• University of Pennsylvania: lead
• Alevio LLC: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• Palermo EH, Young AV, Deswert S, Brown A, Goldberg M, Sultanik E, Tan J, Mazefsky CA, Brookman-Frazee L, McPartland JC, Goodwin MS, Pennington J, Marcus SC, Beidas RS, Mandell DS, Nuske HJ. A Digital Mental Health App Incorporating Wearable Biosensing for Teachers of Children on the Autism Spectrum to Support Emotion Regulation: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 26;12:e45852. doi: 10.2196/45852.

  PMID: 37358908 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be grouped into teams (child with autism, their teacher, and their parent) and teams will be randomized to one of the two arms. Teams (n = 10) randomized to the intervention will be given the KeepCalm application to use for 3 months. Teams randomized to the waitlist control condition (n = 10) will be given access to the app following the study's completion.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 14, 2022
• Study Start: September 26, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)