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Front Neurosci. 2019 Feb 27;13:111. doi: 10.3389/fnins.2019.00111. eCollection 2019.

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

Author information

1
Neuroscience Therapeutic Area, Janssen Research & Development, Titusville, FL, United States.
2
Computational Biology, Discovery Sciences, Janssen Research & Development, Beerse, Belgium.
3
Statistically Speaking Consulting, LLC, Chicago, IL, United States.
4
Informatics, Janssen Research & Development, Spring House, PA, United States.
5
Statistical Decision Sciences, Janssen Research & Development, Titusville, NJ, United States.
6
Computational Biology, Discovery Sciences, Janssen Research & Development, Spring House, PA, United States.
7
Departments of Psychiatry and Behavioral Sciences, Duke Center for Autism and Brain Development, Duke University School of Medicine, Durham, NC, United States.
8
Department of Health Sciences, Northeastern University, Boston, MA, United States.
9
Department of Psychiatry, School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
10
Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
11
Department of Pediatrics, University of Washington, Seattle, WA, United States.
12
Eunice Kennedy Shriver Center and Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, United States.
13
Department of Developmental-Behavioral Pediatrics, Children's Specialized Hospital, Toms River, NJ, United States.
14
Center for Autism Research, Perelman School of Medicine, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States.
15
Southwest Autism Research & Resource Center, Phoenix, AZ, United States.
16
Department of Outpatient Research, Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, United States.
17
Neuroscience Therapeutic Area, Janssen Research & Development, Pennington, NJ, United States.

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.

KEYWORDS:

assessment; autism spectrum disorder (ASD); biosensor; mood report; web and mobile application

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