+1 Recommend
1 collections

      To submit your manuscript, please click here

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      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


      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.



          As much as 80% of children on the autism spectrum exhibit challenging behaviors (ie, behaviors dangerous to the self or others, behaviors that interfere with learning and development, and behaviors that interfere with socialization) that can have a devastating impact on personal and family well-being, contribute to teacher burnout, and even require hospitalization. Evidence-based practices to reduce these behaviors emphasize identifying triggers (events or antecedents that lead to challenging behaviors); however, parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow the measurement of momentary emotion dysregulation using physiological indexes.


          We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by 3 key factors: children on the autism spectrum often have difficulties in communicating their emotions; it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by communicating children’s stress to their teachers using physiological signaling (emotion dysregulation detection), supporting the implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child according to their behavior (emotion regulation strategy implementation), and easing the task of tracking outcomes by providing the child’s educational team with a tool to track the most effective emotion regulation strategies for that child based on physiological stress reduction data (emotion regulation strategy evaluation).


          We will test KeepCalm with 20 educational teams of students on the autism spectrum with challenging behaviors (no exclusion based on IQ or speaking ability) in a pilot randomized waitlist-controlled field trial over a 3-month period. We will examine the usability, acceptability, feasibility, and appropriateness of KeepCalm as primary outcomes. Secondary preliminary efficacy outcomes include clinical decision support success, false positives or false negatives of stress alerts, and the reduction of challenging behaviors and emotion dysregulation. We will also examine technical outcomes, including the number of artifacts and the proportion of time children are engaged in high physical movement based on accelerometry data; test the feasibility of our recruitment strategies; and test the response rate and sensitivity to change of our measures, in preparation for a future fully powered large-scale randomized controlled trial.


          The pilot trial will begin by September 2023.


          Results will provide key data about important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data about its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum.

          Trial Registration

          ClinicalTrials.gov NCT05277194; https://www.clinicaltrials.gov/ct2/show/NCT05277194

          International Registered Report Identifier (IRRID)


          Related collections

          Most cited references74

          • Record: found
          • Abstract: found
          • Article: not found

          The pupil as a measure of emotional arousal and autonomic activation.

          Pupil diameter was monitored during picture viewing to assess effects of hedonic valence and emotional arousal on pupillary responses. Autonomic activity (heart rate and skin conductance) was concurrently measured to determine whether pupillary changes are mediated by parasympathetic or sympathetic activation. Following an initial light reflex, pupillary changes were larger when viewing emotionally arousing pictures, regardless of whether these were pleasant or unpleasant. Pupillary changes during picture viewing covaried with skin conductance change, supporting the interpretation that sympathetic nervous system activity modulates these changes in the context of affective picture viewing. Taken together, the data provide strong support for the hypothesis that the pupil's response during affective picture viewing reflects emotional arousal associated with increased sympathetic activity.
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support

            Background The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual’s changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual’s state can change rapidly, unexpectedly, and in his/her natural environment. Purpose Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusions As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention We clarify the scientific motivation for the Just-In-Time Adaptive Interventions, define its fundamental components, and discuss key design principles for each component.
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Psychometric assessment of three newly developed implementation outcome measures

              Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change. Results All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions. Conclusions The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0635-3) contains supplementary material, which is available to authorized users.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                26 June 2023
                : 12
                : e45852
                [1 ] Penn Center for Mental Health Perelman School of Medicine University of Pennsylvania Philadelphia, PA United States
                [2 ] Alevio LLC Philadelphia, PA United States
                [3 ] School of Dental Medicine University of Pennsylvania Philadelphia, PA United States
                [4 ] Department of Psychiatry University of Pittsburgh Pittsburgh, PA United States
                [5 ] Department of Psychiatry University of California San Diego San Diego, CA United States
                [6 ] Yale Child Study Center Yale University New Haven, CT United States
                [7 ] Bouvé College of Health Sciences Northeastern University Boston, MA United States
                [8 ] Children's Hospital of Philadelphia Research Institute Children's Hospital of Philadelphia Philadelphia, PA United States
                [9 ] School of Social Policy and Practice University of Pennsylvania Philadelphia, PA United States
                [10 ] Department of Medical Social Sciences, Feinberg School of Medicine Northwestern University Chicago, IL United States
                Author notes
                Corresponding Author: Heather J Nuske heather.nuske@ 123456pennmedicine.upenn.edu
                Author information
                ©Emma H Palermo, Amanda V Young, Sky Deswert, Alyssa Brown, Miranda Goldberg, Evan Sultanik, Jessica Tan, Carla A Mazefsky, Lauren Brookman-Frazee, James C McPartland, Matthew S Goodwin, Jeffrey Pennington, Steven C Marcus, Rinad S Beidas, David S Mandell, Heather J Nuske. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.06.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 23 January 2023
                : 19 February 2023
                : 24 March 2023
                : 30 March 2023
                Custom metadata
                The proposal for this study was peer reviewed by the Center for Scientific Review Special Emphasis Panel - National Institute of Mental Health (National Institutes of Health, USA). See the Multimedia Appendix for the peer-review report.

                digital mental health,just-in-time adaptive intervention augmentation,jitai,autism,heart rate tracking,emotion dysregulation,challenging behavior,evidence-based strategies,student progress monitoring,mobile phone


                Comment on this article