An Observational Study With the Janssen Autism Knowledge Engine (JAKE®) in Individuals With Autism Spectrum Disorder

Abstract

Objective: The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components. Methods: An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures. Results: Individuals with ASD ( N = 144) and a cohort of typically developing (TD) individuals ( N = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was “easy” (69%, 74/108) or “very easy” (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93–100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported. Conclusions: My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02668991 identifier: NCT02668991

Bringing the Laboratory Home: PANDABox Telehealth-Based Assessment of Neurodevelopmental Risk in Children

“…Despite these advances, a notable gap remains: when implemented outside of controlled laboratory settings, biosensors and other spectral measures are rarely integrated with observed behavioral data in studies of neurodevelopmental disorders. Indeed, most clinical studies using commercial-grade wearable devices focus on broad patterns of daily activity, such as number of vocalizations (Reisinger et al, 2019) or patterns of heart rate (Ness et al, 2019). Other fields have linked these types of data to daily events or patient-reported experiences, such as through environmental momentary assessment (Raugh et al, 2019).…”

Visual Preference for Biological Motion in Children and Adults with Autism Spectrum Disorder: An Eye-Tracking Study

“…This biological motion task was part of a large, observational, multi-center study conducted from 06 July 2015 to 14 October 2016 at nine study sites in the US (ClinicalTrials. gov, NCT02668991) and consisted of passive viewing tasks 12.0 (6-54) 11.5 (6-63) P-value 0.69 ADOS-2 total score, mean (SD, range) 7.6 (1.7, 4-10) -KBIT-2 IQ composite score, mean (SD, range) 98.5 (20.0, 60-136) - (Bangerter et al 2020a(Bangerter et al , 2020bJagannatha et al 2019;Manfredonia et al 2018;Manyakov et al 2018;Ness et al 2019;Sargsyan et al 2019). In this study, both groups of participants completed the same set of biosensor tasks.…”

“…There is some evidence that attention to PLD biological motion may be sensitive to changes in social cognition; for example, TD adults administered oxytocin showed increased perception of PLD biological motion (Kéri and Benedek 2009). These attention changes detected by ET may be linked to neurophysiology and modulation of an electroencephalogram, wherein enhanced suppression in mu and beta bands are associated with biological motion and social stimuli perception (Perry et al 2010). Interestingly, neural responses to biological motion are found to vary with autistic-like traits in TD adults (Puglia and Morris 2017).…”

Qualitative Evaluation of the Autism Behavior Inventory: Use of Cognitive Interviewing to Establish Validity of a Caregiver Report Scale for Autism Spectrum Disorder

“…Similarly, despite counterbalancing efforts, the sample was not robustly representative of minority populations. The study participants viewed an online pdf of the ABI rather than the actual web-based form itself, which may have impacted participant responses and did not provide electronic usability evaluation, though information on the usability and acceptability of the online version of the ABI has been reported elsewhere [23,24]. Finally, not all participants completed all items.…”