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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02299700

ASD-001 (Other Identifier)

CR104919

Details and patient eligibility

About

The purpose of this study is to assess the usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in autism spectrum disorder (ASD) (severe abnormalities in the development of many basic psychological functions that are not normal for any stage in development. These abnormalities are manifested in sustained social impairment, speech abnormalities, and peculiar motor movements).

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 3 patient groups

Autism Spectrum Disorder (ASD) Participants (6-9 years)

Description:

Participants with ASD aged 6 to 9 years will be observed for the usability of the Janssen Autism Knowledge Engine (JAKE) personal healthcare record (pHR) and biosensors in stage 1 and stage 2 (at laboratory sites).

Treatment:

Other: No Intervention

ASD Participants (13-17 years)

Description:

Participants with ASD aged 13 to 17 years will be observed for the usability of the JAKE pHR and biosensors in stage 1 and stage 2 (at laboratory sites).

Treatment:

Other: No Intervention

ASD Participants (3 or greater than 3 years)

Description:

Participants with ASD aged 3 or greater than 3 years will be observed for the usability of the JAKE pHR and biosensors in stage 2 (at clinical sites).

Treatment:

Other: No Intervention