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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299700
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date September 29, 2014
First Posted Date November 24, 2014
Last Update Posted Date October 23, 2017
Actual Study Start Date September 30, 2014
Actual Primary Completion Date April 24, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2014)
  • Stage 1: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) [ Time Frame: Week 1 ]
    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, symptom tracker, 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 symptom tracker and biosensors. An exit survey will assess overall usability of the system.
  • Stage 2: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD [ Time Frame: Week 4 ]
    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, Symptom Tracker, 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 symptom tracker and biosensors. An exit survey will assess overall usability of the system.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2014)
  • Utility of JAKE Symptom Tracker in Measuring Clinical Symptoms of ASD [ Time Frame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2 ]
    The JAKE Symptom Tracker is a series of 97 questions related to the core and associated symptoms of ASD. Questions are answered on two 4-point scales, either frequency and intensity, frequency and context, or quality and context.
  • Correlation Between Key Biosensors and ASD Symptoms [ Time Frame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2 ]
    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 symptom tracker, and the event tracker).
  • Ease of use and Utility of JAKE for use in Prospective Clinical Trials [ Time Frame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2 ]
    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, Symptom Tracker, Journal/ASD events, Treatment Tracker, Dashboard, HealthVault, Research Data Warehouse and Workbench.
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 1 in Stage 1, and Up to Week 8 in Stage 2 ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
Official Title A Study to Preliminarily Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
Brief Summary 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).
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children and Adult participants with history of Autism Spectrum Disorder will be observed.
Condition Autism Spectrum Disorder
Intervention Other: No Intervention
The usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in Autism Spectrum Disorder (ASD) will be observed.
Study Groups/Cohorts
  • Autism Spectrum Disorder (ASD) Participants (6-9 years)
    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).
    Intervention: Other: No Intervention
  • ASD Participants (13-17 years)
    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).
    Intervention: Other: No Intervention
  • ASD Participants (3 or greater than 3 years)
    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).
    Intervention: Other: No Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 2, 2015)
34
Original Estimated Enrollment
 (submitted: November 20, 2014)
80
Actual Study Completion Date April 24, 2015
Actual Primary Completion Date April 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02299700
Other Study ID Numbers CR104919
ASD-001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor Janssen Research & Development, LLC
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2017