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)

BACKGROUND As many as 80% of children on the autism spectrum exhibit challenging behaviors (i.e., behaviors dangerous to the self or others, behaviors that interfere with learning and development, and/or 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), yet parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow measurement of momentary emotion dysregulation using physiological indices. OBJECTIVE We present the framework and protocol for a novel pilot trial that will test a mobile digital mental health application, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by three key factors: 1) children on the autism spectrum often have difficulties communicating their emotions; 2) it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and 3) it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by 1) communicating children’s stress to their teachers using physiological signaling (emotion dysregulation detection); 2) supporting implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child per behavior (emotion regulation strategy implementation); and 3) easing the burden 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). METHODS 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/negatives of stress alerts, and 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. RESULTS The pilot trial will begin in 2023. CONCLUSIONS Results will provide key data on important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data on its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum. CLINICALTRIAL ClinicalTrials.gov ID: NCT05277194