Clinical Trial: Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Study to Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder and in a Normally Developing Cohort

Brief Summary: The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.

Detailed Summary: This is an observational study (in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) to evaluate the utility of Janssen Autism Knowledge Engine (JAKE) in measuring clinical symptoms of ASD in children and adults with ASD. The study will consist of 3 cohorts of participants. For Cohort 1 and 2, there will be 14-day Screening phase and 8-week (Cohort 1) or 10 week (Cohort 2) data collection phase extending from Day 0 (Baseline) to Day 56 or Day 70, respectively. For Cohort 3, the study will consist of a screening visit and a single testing visit, which may be combined. 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) [ Time Frame: up to Week 10 ]

The ABI is a series of 73 questions related to the core and associated symptoms of ASD. Questions are answered on two 4-point scales, consisting of ratings of frequency and intensity, frequency and context, or quality and context.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD [ Time Frame: up to Week 10 ]
    The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, Autism Behavior Inventory (ABI), Journal/ASD events, Treatment Tracker, Dashboard, HealthVault, Research Data Warehouse and Workbench. Results of several parent and clinician questionnaires will be compared with the findings of the mentis ABI and biosensors. An exit survey will assess overall usability of the system.
  • Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms [ Time Frame: up to Week 10 ]
    The utility of the biosensors will be determined by measuring the associations between the biosensors and the ASD symptoms (response to tasks and stimuli in lab, the ABI, standard scales, and the event tracker).
  • Correlation Between Genomic Characteristics and Autism Phenotypes [ Time Frame: up to Week 10 ]
    Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
  • Usability of the JAKE System to detect changes in response to standard [ Time Frame: up to Week 10 ]
    Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to Week 10 ]
  • Normative data on the JAKE Biosensor Array (Continuous and Periodic) [ Time Frame: up to Week 10 ]
    Normative data on the JAKE biosensor array (Continuous and Periodic) will be collected. Comparisons between Cohort 3 and Cohorts 1 and 2 will be made to examine differences between normally developing and ASD participants.
  • Normative data on the JAKE Task Battery [ Time Frame: up to Week 10 ]
    Normative data on the JAKE task battery will be collected. Comparisons between Cohort 3 and Cohorts 1 and 2 will be made to examine differences between normally developing and ASD participants.
  • Ease of use of JAKE for use in Prospective Clinical Trials [ Time Frame: up to Week 10 ]
    The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, ABI, Journal/ASD events, Treatment Tracker, Dashboard, Health Vault, Research Data Warehouse and Workbench.
  • Utility of JAKE for use in Prospective Clinical Trials [ Time Frame: up to Week 10 ]
    The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, ABI, Journal/ASD events, Treatment Tracker, Dashboard, Health Vault, Research Data Warehouse and Workbench.


Original Secondary Outcome:

  • Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD [ Time Frame: up to Week 10 ]
    The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, Autism Behavior Inventory (ABI), Journal/ASD events, Treatment Tracker, Dashboard, HealthVault, Research Data Warehouse and Workbench. Results of several parent and clinician questionnaires will be compared with the findings of the mentis ABI and biosensors. An exit survey will assess overall usability of the system.
  • Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms [ Time Frame: up to Week 10 ]
    The utility of the biosensors will be determined by measuring the associations between the biosensors and the ASD symptoms (response to tasks and stimuli in lab, the ABI, standard scales, and the event tracker).
  • Ease of use and Utility of JAKE for use in Prospective Clinical Trials [ Time Frame: up to Week 10 ]
    The JAKE personal healthcare record (pHR) encompasses various modules for use by clinicians, caregivers, participants and the sponsor. The JAKE is accessible both through a web interface for computers and applications for mobile devices. The modules are Medical/Developmental History, ABI, Journal/ASD events, Treatment Tracker, Dashboard, Health Vault, Research Data Warehouse and Workbench.
  • Correlation Between Genomic Characteristics and Autism Phenotypes [ Time Frame: up to Week 10 ]
    Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
  • Usability of the JAKE System to detect changes in response to standard [ Time Frame: up to Week 10 ]
    Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to Week 10 ]
  • Normative data on the JAKE Biosensor Array (Continuous and Periodic) and the JAKE Task Battery [ Time Frame: up to Week 10 ]
    Normative data on the JAKE biosensor array (Continuous and Periodic) and the JAKE task battery will be collected. Comparisons between Cohort 3 and Cohorts 1 and 2 will be made to examine differences between normally developing and ASD participants.


Information By: Janssen Research & Development, LLC

Dates:
Date Received: January 27, 2016
Date Started: July 2015
Date Completion:
Last Updated: December 16, 2016
Last Verified: December 2016