Digital Health App for Autism

Overseen By David S Mandell, ScD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: No challenging behaviors

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mobile app called KeepCalm, designed to help manage stress and challenging behaviors in children with autism. The app monitors heart rate to detect stress and suggests personalized strategies for teachers to use in the classroom. It also enables teachers to track effective methods and share this information with parents. This app suits preschool or elementary school children with autism who exhibit challenging behaviors such as aggression or loud noises, and it requires teachers or aides who can use an iPhone. As an unphased trial, the study provides a unique opportunity to explore innovative solutions for managing autism-related challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this m-health app is safe for children with autism?

Research has shown that the KeepCalm app is safe for children with autism. The app manages stress and challenging behaviors by monitoring heart rate and offering helpful tips. As a digital tool, it involves no physical contact.

Studies of similar apps indicate that digital health tools like KeepCalm are usually well-received, with users reporting few, if any, side effects. The app avoids medication, thus eliminating risks such as drug side effects or allergies.

Overall, current research suggests that the KeepCalm app is safe. It provides a gentle way to help children with autism manage their emotions and behaviors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KeepCalm app because it offers a new way to manage stress and prevent challenging behaviors in children with autism. Unlike traditional behavioral therapies that require consistent in-person sessions, the app provides real-time physiological stress tracking using heart rate monitoring. This allows the app to anticipate when challenging behaviors might occur and suggest strategies to prevent them, making it a proactive tool. Additionally, it helps track and communicate behavioral trends and triggers, providing valuable insights to parents and educators.

What evidence suggests that the KeepCalm app is effective for managing challenging behaviors in children with autism?

In this trial, participants will either use the KeepCalm app or join a waitlist control group. Studies have shown that the KeepCalm app can help children with autism manage their emotions. It uses wearable technology to monitor heart rate and predict stress levels. The app offers personalized tips to help control emotions and reduce difficult behaviors. Early research indicates that it also assists teachers by suggesting specific strategies and tracking which ones are most effective for each child. Based on proven methods, the app is a promising tool for managing stress in children with autism. Overall, the KeepCalm app shows potential in providing a more customized way to handle challenging behaviors in these children. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child shows challenging behaviors such as aggression or self-injury.

My child has autism and is in preschool or elementary school.

Adults must have an iPhone to test the app, or be willing to use a provided study iPhone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Pilot Testing

Development and pilot testing of the KeepCalm app, including interviews and structured observations with teachers, parents, and school administrators.

3 months

Monthly advisory board meetings

Randomized Waitlist Field Trial

Testing the app for usability, acceptability, feasibility, and preliminary effectiveness with 30 educational teams.

3 months

Baseline and post-intervention measures

Follow-up

Participants are monitored for safety and effectiveness after the trial period.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• KeepCalm app

Trial Overview

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.

How Is the Trial Designed?

Group I: KeepCalm App Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Alevio LLC

Collaborator

Trials

1

Recruited

20+

Alevio Inc.

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

The My JAKE app was successfully used by 144 caregivers of individuals with autism spectrum disorder (ASD) to log daily symptoms and behaviors over an 8- to 10-week period, showing that real-time reporting can effectively capture behavioral data.

Caregivers reported high satisfaction with the app, with over 50% expressing interest in continuing its use beyond the study, indicating that mHealth tools like My JAKE could enhance the accuracy of symptom tracking and improve the understanding of ASD interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. Bangerter, A., Manyakov, NV., Lewin, D., et al.[2023]

The PuzzleWalk mobile app was found to be user-friendly and effective for promoting physical activity among both adults with and without autism spectrum disorder (ASD), based on a study involving 18 participants.

Qualitative interviews revealed important insights into the specific health and social needs of adults with ASD, highlighting areas for improvement in future iterations of the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability inquiry of a gamified behavior change app for increasing physical activity and reducing sedentary behavior in adults with and without autism spectrum disorder. Lee, D., Frey, GC., Min, A., et al.[2021]

The Footsteps app was developed to improve data collection practices among one-to-one aides working with children with autism, addressing challenges like labor-intensive methods and lack of supervisor feedback.

In testing with 10 aides and supervisors, 90% rated the app's usability as good or excellent, indicating strong potential for enhancing data collection and monitoring client progress in behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making Progress Monitoring Easier and More Motivating: Developing a Client Data Collection App Incorporating User-Centered Design and Behavioral Economics Insights. Nuske, HJ., Buck, J., Ramesh, B., et al.[2023]

In a study involving 18 children and adults with autism spectrum disorders (ASD), the Empowered Brain AR smartglasses were found to be safe, with 89% of users able to wear and use the device without reporting negative effects.

Caregivers also reported no negative effects, and the majority of users and caregivers expressed satisfaction with the design, indicating that AR technology could be a beneficial tool for social communication in individuals with ASD, although further research is needed on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. Sahin, NT., Keshav, NU., Salisbury, JP., et al.[2023]

A smartwatch system designed for individuals with Autism Spectrum Disorders (ASD) effectively helps users manage emotional self-regulation by utilizing physiological signals and movement patterns, demonstrating its potential as a non-stigmatizing support tool.

In a nine-day experiment with two participants, the smartwatch enabled them to successfully implement customized self-regulation strategies, leading to recovery from most mild stress episodes and temper tantrums in a classroom setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional Self-Regulation of Individuals with Autism Spectrum Disorders: Smartwatches for Monitoring and Interaction. Torrado, JC., Gomez, J., Montoro, G.[2018]

Mobile apps designed for autism care can be categorized into various types, including support, educational, and data collection apps, each targeting different users such as individuals with autism, teachers, and parents.

These apps utilize innovative features like gamification and virtual reality, along with user-centered design principles, to enhance usability and effectiveness in improving autism symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Survey on Autism Care, Diagnosis, and Intervention Based on Mobile Apps Focusing on Usability and Software Design. Liu, X., Zhao, W., Qi, Q., et al.[2023]

In a study involving 78 preschool children with autism spectrum disorder (ASD), the addition of virtual reality-incorporated cognitive behavioral therapy (VR-CBT) to a learning style profile (LSP) intervention significantly improved core symptoms of ASD, as measured by the Autism Behavior Checklist (ABC) and the Childhood Autism Rating Scale (CARS).

The VR-CBT intervention also led to notable improvements in behavioral performance on tasks requiring response inhibition and reduced hyperactivity-impulsivity symptoms in children with comorbid ADHD, indicating its potential as an effective adjunctive digital therapy for young children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. Chu, L., Shen, L., Ma, C., et al.[2023]

A mobile app was created to help caregivers of autistic children improve their knowledge about oral health and dental visits, featuring customized social stories and visual schedules.

The app and its content were positively reviewed by both experts and parents, indicating its potential effectiveness in supporting dental care for autistic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of oral health resources and a mobile app for caregivers and autistic children through consensus building. Tan, BL., Nair, R., Duggal, MS., et al.[2023]

Digital health products, particularly mobile apps, have the potential to reduce diagnostic delays in autism, which can take up to 3 years, by providing timely information to clinicians during assessments.

A review of 4 studies on digital biomarker apps showed varying accuracy (28% to 80.6%) and sensitivity (51.6% to 81.6%), highlighting the need for standardized evaluation methods to ensure their reliability and effectiveness in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App Characteristics and Accuracy Metrics of Available Digital Biomarkers for Autism: Scoping Review. Ponzo, S., May, M., Tamayo-Elizalde, M., et al.[2023]

The multimedia application Thea aims to enhance the Therapeutic Alliance (TA) for children with Autism Spectrum Disorder (ASD) by improving communication among caregivers, therapists, and educators, which is crucial for effective therapy.

User studies indicated that Thea positively empowered caregivers, increasing their confidence in managing the care of children with ASD, suggesting that the application can facilitate better-informed interactions and strategies for handling challenging behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thea: empowering the therapeutic alliance of children with ASD by multimedia interaction. Francese, R., Risi, M., Tortora, G., et al.[2022]

The study involved 40 children aged 9 to 15 with autism spectrum disorder, comparing a communication app to the Picture Exchange Communication System (PECS) for facilitating dentist-patient interactions.

The app significantly reduced the number of attempts needed to communicate effectively and decreased the number of dental appointments required for preventive care compared to PECS, indicating its greater efficacy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Application for Use During the First Dental Visit for Children and Adolescents with Autism Spectrum Disorders. Zink, AG., Molina, EC., Diniz, MB., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10337316/

Protocol for a Pilot Randomized Controlled Trial - PMC

The KeepCalm app offers individualized “top strategy” suggestions from an up-to-date list of evidence-based strategies for supporting emotion regulation and ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39441712/

Supporting emotion regulation in children on the autism ...

KeepCalm is a digital mental health application, co-designed with community partners, that incorporates wearable biosensing with support for teams.

3.

researchgate.net

researchgate.net/figure/KeepCalm-app-design_fig3_369676928

KeepCalm app design. | Download Scientific Diagram

A digital mental health application incorporating wearable biosensing for teachers of children on the autism spectrum to support emotion regulation.

4.

withpower.com

withpower.com/trial/phase-autistic-disorder-8-2022-dfbec

Digital Health App for Autism · Info for Participants

The KeepCalm app is unique because it is a digital health tool designed to help individuals with autism manage their emotions through personalized strategies on ...

5.

app.dimensions.ai

app.dimensions.ai/details/grant/grant.9330902

Reducing Challenging Behaviors In Children With Autism ...

PROJECT SUMMARY The project will develop and pilot test a personalized medicine mobile health application, KeepCalm, that incorporates physiological stress ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11753873/

Supporting emotion regulation in children on the autism ...

To our knowledge, KeepCalm is the first app designed to help teachers support students on the autism spectrum to address behaviors and emotion ...

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digitalmentalhealth.org

digitalmentalhealth.org/keep-calm

KeepCalm App

The KeepCalm app is designed to be an interactive learning and data collection tool to facilitate a team approach to supporting emotion regulation in students.

8.

researchgate.net

researchgate.net/publication/369676928_A_Digital_Mental_Health_Application_Incorporating_Wearable_Biosensing_for_Teachers_of_Children_on_the_Autism_Spectrum_to_Support_Emotion_Regulation_Pilot_Randomized_Field_Trial_Protocol_Preprint

Pilot Randomized Field Trial Protocol (Preprint)

We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app.