Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder

This is an observational (study in which participants identified as belonging to study groups
are assessed for biomedical or health outcomes) and prospective (study following participants
forward in time) study to determine JAKE in children and adults with ASD. The study will be
conducted in 2 stages and each stage consists of 2 parts: Screening Phase (14 days), data
collection Phase (Stage 1: 1 week and Stage 2: 4 weeks) and, stage 2 has follow-up Phase (up
to 4 weeks post-data collection). The maximum study duration for each participant will not
exceed 1 week for stage 1 and 8 weeks for stage 2. Primarily, the usability of JAKE as a
system to monitor clinical outcomes in ASD will be assessed. Participants' safety will be
monitored throughout the study.

Inclusion Criteria:

- Participants can receive behavioral and/or pharmacologic treatments for Autism
Spectrum Disorder (ASD) and comorbid disorders during the course of the study

- Parents or legally acceptable representatives must speak and understand English

- Participants must live with a parent or primary caregiver or, if not, they must either
(A) spend at least 3 hours a day for at least 4 days each week or, (B) spend at least
3 weekends a month with a parent or primary caregiver

- Parents or legally acceptable representatives must possess (A) a portable electronic
device capable of running the Janssen Autism Knowledge Engine (JAKE) application and
connecting to the internet, and (B) a laptop or desktop computer connected to the
internet

- In the opinion of the Investigator, participant and parents must be capable of
completing all procedures and tasks of the study

- Diagnosis of ASD made or confirmed by the Investigator according to Diagnostic and
Statistical Manual of Mental Disorders (5th edition) criteria using a DSM V checklist
and at least a 'mild' rating on the Child Autism Rating Scale 2 (CARS-2)

Exclusion Criteria:

- Lab sites only: Measured composite score on the Vineland Adaptive Behavior Scales
(VABS) of less than 60

- History of or current significant medical illness that the Investigator considers
should exclude the participant

- Psychological and/or emotional problems which would render the informed consent
invalid or limit the ability of the participant to comply with the study requirements

- Any condition that in the opinion of the Investigator would complicate or compromise
the study, or the wellbeing of the participant; for example, visual problems that
would impede eye tracking or viewing the stimuli or hearing problems that would impede
hearing auditory stimuli

- Employees of the Investigator or study center, with direct involvement in the proposed
study or other studies under the direction of that Investigator or study center, as
well as family members of the employees or the Investigator