Autism Spectrum DisorderNCT05277194
Reducing Challenging Behaviors in Children With Autism Through Digital Health
A study testing KeepCalm app in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- KeepCalm app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 30 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Child does not exhibit challenging behaviors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19146
About this study
Official title: Investigating the Impact of an Emotional Stress Alarm App (KeepCalm) on Managing Stress and Preventing Challenging Behaviors in Children With Autism
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.
Read the detailed description
The project will develop and pilot test a personalized medicine mobile health emotion regulation application (the m-health KeepCalm app) that incorporates physiological stress measurement to support evidence-based practices for reducing challenging behavior in children with autism spectrum disorder (ASD). As much as 80% of children with ASD exhibit challenging behaviors that can have a devastating impact on personal and family well-being, contribute to teacher burnout and require frequent hospitalization. Evidence-based practices for reducing these behaviors emphasize uncovering triggers, yet parents and teachers often report that challenging behaviors surface without warning. Challenging behaviors caused by emotion dysregulation can be the most difficult to predict, as children with ASD often have difficulty communicating their distress before it results in challenging behavior. Exciting recent advances in digital technology now allow measurement of momentary emotion dysregulation, using physiological indices. The investigators' pilot data from four separate samples demonstrate that increased heart rate predicts onset of challenging behavior in children with ASD. In order to tailor the m-health KeepCalm app to end users and avoid potential barriers to its adoption, in Aim 1, the investigators will evaluate the acceptability, feasibility, and appropriateness of app, and the needs of educational teams in managing stress in children with ASD and challenging behaviors, by conducting interviews with teachers of children with ASD, parents of children with ASD and school administrators, and conducting structured in-class observations with teachers. Through the activities of Aim 2, the researchers will improve the m-health KeepCalm app, building on their initial app prototype, in collaboration with their established research partner, the Translational Informatics Unit, Children's Hospital of Philadelphia, and their established community partner, the School District of Philadelphia. The investigators will do this through 1) exploratory work on the specificity of heart rate increase to challenging behavior, on app clinical decision support timing, and on the association of app false positives and negatives to movement or child factors; 2) monthly advisory board meetings with expert stakeholders for app development guidance, and; 3) rapid-cycle prototyping of the app with 10 educational teams (i.e. 1-2 children with ASD, and their teacher and classroom aide, if they have one). This will allow for iterative improvement based on each user's experience. Through Aim 3, the researchers will test the app for usability, acceptability, feasibility and appropriateness, as well as preliminary effectiveness with 30 educational teams in a randomized waitlist field trial over a 3-month period. Successful completion of these aims will result in a novel m-health app designed to help teachers support emotion regulation, and reduce or prevent challenging behavior in children with ASD, using evidence-based strategies. These activities will lay the foundation for an R01 to evaluate the effectiveness of the m-health KeepCalm app in a full- scale randomized field trial. This proposal aligns with the strategic plan of the Interagency Autism Coordinating Committee, to maximize the potential for technology-based interventions to improve the lives of people with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- KeepCalm app
- Keywords
- emotion regulation, digital mental health, preschool, elementary school, Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeepCalm appBehavioural
The KeepCalm app is designed to help manage stress and prevent challenging behaviors in children with autism.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
Secondary outcomes (20)
School Situations Questionnaire (SSQ) - Problems Score - Baseline
The School Situations Questionnaire (SSQ) assessing challenging behaviors within the context of school. The scale assesses both the presence and the severity of challenging behaviors by asking the teacher whether or not a given behavior occurs for that child and to rate the severity. The scale yields two summary scores. The first is the number of problems score which is a sum of the number of problems endorsed, ranging from 0-12 with higher scores indicating greater problems endorsed. The second is the mean severity, calculated as the mean severity for the items endorsed, ranging from 1 to 9 with higher numbers indicating more severe problems.
Measured: Baseline
School Situations Questionnaire (SSQ) Problems Score - Post-Trial
The School Situations Questionnaire (SSQ) assessing challenging behaviors within the context of school. The scale assesses both the presence and the severity of challenging behaviors by asking the teacher whether or not a given behavior occurs for that child and to rate the severity. The scale yields two summary scores. The first is the number of problems score which is a sum of the number of problems endorsed, ranging from 0-8 with higher scores indicating greater problems endorsed. The second is the mean severity, calculated as the mean severity for the items endorsed, ranging from 1 to 9 with higher numbers indicating more severe problems.
Measured: Week 12
School Situations Questionnaire (SSQ) - Severity Score - Baseline
The School Situations Questionnaire (SSQ) assessing challenging behaviors within the context of school. The scale assesses both the presence and the severity of challenging behaviors by asking the teacher whether or not a given behavior occurs for that child and to rate the severity. The scale yields two summary scores. The first is the number of problems score which is a sum of the number of problems endorsed, ranging from 0-8 with higher scores indicating greater problems endorsed. The second is the mean severity, calculated as the mean severity for the items endorsed, ranging from 1 to 9 with higher numbers indicating more severe problems.
Measured: Baseline
School Situations Questionnaire (SSQ) - Severity Score - Post-Trials
The School Situations Questionnaire (SSQ) assessing challenging behaviors within the context of school. The scale assesses both the presence and the severity of challenging behaviors by asking the teacher whether or not a given behavior occurs for that child and to rate the severity. The scale yields two summary scores. The first is the number of problems score which is a sum of the number of problems endorsed, ranging from 0-8 with higher scores indicating greater problems endorsed. The second is the mean severity, calculated as the mean severity for the items endorsed, ranging from 1 to 9 with higher numbers indicating more severe problems.
Measured: 12 Weeks
Open-Source Challenging Behavior Scale (OS-CBS) - Baseline
An 18-item informant-report measure of challenging behavior severity in children ages 2-17 with autism spectrum disorder or other neurodevelopmental disabilities. Items are rated on a 5-point Likert scale (1=not at all a problem; 5=very severe problem) reflecting severity over the past month. The total score is the mean of all 18 items, with higher scores indicating greater challenging behavior severity.
Measured: Baseline
Open-Source Challenging Behavior Scale (OS-CBS) - Post-Trial
An 18-item informant-report measure of challenging behavior severity in children ages 2-17 with autism spectrum disorder or other neurodevelopmental disabilities. Items are rated on a 5-point Likert scale (1=not at all a problem; 5=very severe problem) reflecting severity over the past month. The total score is the mean of all 18 items, with higher scores indicating greater challenging behavior severity.
Measured: 3 months post-baseline
Emotion Dysregulation Inventory (EDI) - Reactivity - Baseline
The Emotion Dysregulation Inventory (EDI) Reactivity Index is a parent/caregiver-rated measure of rapid, intense emotional responses and difficulty calming down, rated on a 5-point scale (0 = "not at all" to 4 = "very severe") over the past 7 days. For participants ages 6 and older, the standard EDI 24-item version is administered; for ages 2-5, the EDI-Young Child (EDI-YC) 15-item version is administered. Raw scores are converted to T-scores using IRT-based conversion tables, where the T-score metric has a population mean of 50 and standard deviation of 10. In this study, T-scores ranged from 25.550 to 77.890, with higher scores indicating greater reactivity. Using the clinical (ASD/developmental disability) sample norms, scores at or above 49.070 are considered clinically elevated.
Measured: Baseline
Emotion Dysregulation Inventory (EDI) - Reactivity - Post-Trial
The Emotion Dysregulation Inventory (EDI) Reactivity Index is a parent/caregiver-rated measure of rapid, intense emotional responses and difficulty calming down, rated on a 5-point scale (0 = "not at all" to 4 = "very severe") over the past 7 days. For participants ages 6 and older, the standard EDI 24-item version is administered; for ages 2-5, the EDI-Young Child (EDI-YC) 15-item version is administered. Raw scores are converted to T-scores using IRT-based conversion tables, where the T-score metric has a population mean of 50 and standard deviation of 10. In this study, T-scores ranged from 25.550 to 77.890, with higher scores indicating greater reactivity. Using the clinical (ASD/developmental disability) sample norms, scores at or above 49.070 are considered clinically elevated.
Measured: Week 12
Emotion Dysregulation Inventory (EDI) - Dysphoria - Baseline
The Emotion Dysregulation Inventory (EDI) Dysphoria Index is a parent/caregiver-rated measure of low mood, anhedonia, and unresponsiveness to positive events, rated on a 5-point scale (0 = "not at all" to 4 = "very severe") over the past 7 days. For participants ages 6 and older, the standard EDI 6-item version is administered; for ages 2-5, the EDI-Young Child (EDI-YC) 7-item version is administered. Raw scores are converted to T-scores using IRT-based conversion tables, where the T-score metric has a population mean of 50 and standard deviation of 10. In this study, T-scores ranged from 39.730 to 87.600, with higher scores indicating greater dysphoria. Using the clinical (ASD/developmental disability) sample norms, scores at or above 51.640 are considered clinically elevated.
Measured: Baseline
Emotion Dysregulation Inventory (EDI) - Dysphoria - Post-Trial
The Emotion Dysregulation Inventory (EDI) Dysphoria Index is a parent/caregiver-rated measure of low mood, anhedonia, and unresponsiveness to positive events, rated on a 5-point scale (0 = "not at all" to 4 = "very severe") over the past 7 days. For participants ages 6 and older, the standard EDI 6-item version is administered; for ages 2-5, the EDI-Young Child (EDI-YC) 7-item version is administered. Raw scores are converted to T-scores using IRT-based conversion tables, where the T-score metric has a population mean of 50 and standard deviation of 10. In this study, T-scores ranged from 39.730 to 87.600, with higher scores indicating greater dysphoria. Using the clinical (ASD/developmental disability) sample norms, scores at or above 51.640 are considered clinically elevated.
Measured: Week 12
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Verbal Aggression Towards Others Subscale - Baseline
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Verbal Aggression Toward Others dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of verbally aggressive behaviors directed toward others, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of verbal aggression toward others.
Measured: Baseline
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Verbal Aggression Towards Others Subscale - Post-Trial
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Verbal Aggression Toward Others dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of verbally aggressive behaviors directed toward others, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of verbal aggression toward others.
Measured: Week 12
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Verbal Aggression Towards Self Subscale - Baseline
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Verbal Aggression Toward Self dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of verbally aggressive behaviors directed toward oneself, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of verbal aggression toward self.
Measured: Baseline
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Verbal Aggression Towards Self Subscale - Post-Trial
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Verbal Aggression Toward Self dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of verbally aggressive behaviors directed toward oneself, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of verbal aggression toward self.
Measured: Week 12
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Others Subscale - Baseline
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Others dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward others, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward others.
Measured: Baseline
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Others Subscale - Post-Trial
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Others dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward others, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward others.
Measured: Week 12
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Objects Subscale - Baseline
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Objects dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward objects, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward objects.
Measured: Baseline
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Objects Subscale - Post-Trial
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Objects dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward objects, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward objects.
Measured: Week 12
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Self Subscale - Baseline
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Self dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward oneself, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward self.
Measured: Baseline
Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) - Physical Aggression Towards Self Subscale - Post-Trial
The Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS) Physical Aggression Toward Self dimension is a 4-item parent/caregiver or teacher-rated measure of the frequency of physically aggressive behaviors directed toward oneself, rated on a scale from 0 ("never") to 3 ("often"). Scores range from 0 to 12, with higher scores indicating greater frequency of physical aggression toward self.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start26 Sep 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Alevio LLC, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277194
- Sponsor's protocol ID
- 829690
- Other IDs
- 1K01MH120509-01A1
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2022
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37358908