Trial record 14 of 678 for:    Autism

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02668991
First received: January 27, 2016
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition Phase
Autism Spectrum Disorder
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) [ Time Frame: up to Week 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD [ Time Frame: up to Week 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Normative data on the JAKE Biosensor Array (Continuous and Periodic) [ Time Frame: up to Week 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1
It will consist of planned 100 children and adults with Autism Spectrum Disorder (ASD) aged 6 years and older with no requirements regarding concurrent therapies or treatments.
Cohort 2
It will consist of planned 50 children and adults aged 6 and older who, as part of their standard care, happen to be beginning a behavioral intervention within 2 weeks after the baseline visit of the study. This intervention can be an applied behavior analysis (ABA) program or similar or a social skills program or a school-based autism program and must be intended to last at least throughout the duration of the study.
Cohort 3
It will consist of planned 30 normally developing children and adults. These participants will only have a single visit wherein they will undergo a single session with the task battery and biosensors. There should be 5 participants aged 6-9 years, 5 aged 10-12 years, 5 aged 13-17 years, and 5 aged 18 years and older. This cohort should approximate the male:female ratio in Cohorts 1 & 2, with approximately 1 female for every 5 males.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and Adult participants with history of Autism Spectrum Disorder (ASD) will be observed.
Criteria

Inclusion Criteria:

Cohort 1 and 2:

  • Participants must be males or females aged 6 years and older with at least one female for every five male participants
  • Diagnosis of ASD made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
  • Participants can receive behavioral and/or pharmacologic treatments for ASD and comorbid disorders during the course of the study, or not (Cohort 1)
  • In cohort 2, as part of their standard care participants must be about to begin a behavioral intervention within 2 weeks after the Baseline visit
  • Parents or legally authorized representatives must speak and understand English

Cohort 3:

  • Participants must be males or females aged 6 years and older with at least one female for every five male participants.
  • Parents or legally authorized representatives must speak and understand English
  • In the opinion of the investigator, subject and parents must be capable of completing all procedures and tasks of the study
  • Each participant or their legally authorized representative must sign an informed consent form (ICF)
  • A score in the normal range on the Social Communication Questionnaire (SCQ) and must not have any Diagnostic and Statistical Manual of Mental Disorders

Exclusion Criteria:

Cohort 1 and 2:

  • Measured composite score on the Kaufmann Brief Intelligence Test-2 (KBIT-2) 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 subject to comply with the study requirements
  • Any condition that in the opinion of the investigator would compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
  • Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Cohort 3:

  • 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 compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
  • Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
  • Participant should not take any sedating medications on the day of the test battery and should not consume caffeine within 2 hours prior to the battery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02668991

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, California
Not yet recruiting
San Francisco, California, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, Massachusetts
Recruiting
Worcester, Massachusetts, United States
United States, New Jersey
Recruiting
Toms River, New Jersey, United States
United States, New York
Recruiting
Orangeburg, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Withdrawn
Providence, Rhode Island, United States
United States, Washington
Recruiting
Seattle, Washington, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02668991     History of Changes
Other Study ID Numbers: CR106701  MENTIS-ASD002 
Study First Received: January 27, 2016
Last Updated: April 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Autism Spectrum Disorder
Janssen Autism Knowledge Engine
Autism Behavior Inventory

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on April 27, 2016