Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
NCT ID: NCT02668991
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
186 participants
OBSERVATIONAL
2015-07-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Phoenix, Arizona, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Worcester, Massachusetts, United States
Toms River, New Jersey, United States
Orangeburg, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Countries
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References
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Kaliukhovich DA, Manyakov NV, Bangerter A, Pandina G. Context Modulates Attention to Faces in Dynamic Social Scenes in Children and Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Oct;52(10):4219-4232. doi: 10.1007/s10803-021-05279-z. Epub 2021 Oct 8.
Kaliukhovich DA, Manyakov NV, Bangerter A, Ness S, Skalkin A, Goodwin MS, Dawson G, Hendren RL, Leventhal B, Hudac CM, Bradshaw J, Shic F, Pandina G. Social attention to activities in children and adults with autism spectrum disorder: effects of context and age. Mol Autism. 2020 Oct 19;11(1):79. doi: 10.1186/s13229-020-00388-5.
Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Ness S, Pandina G. Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. JMIR Ment Health. 2019 Mar 26;6(3):e11365. doi: 10.2196/11365.
Ness SL, Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Frazier JA, Janvier Y, King BH, Miller JS, Smith CJ, Tobe RH, Pandina G. An Observational Study With the Janssen Autism Knowledge Engine (JAKE(R)) in Individuals With Autism Spectrum Disorder. Front Neurosci. 2019 Feb 27;13:111. doi: 10.3389/fnins.2019.00111. eCollection 2019.
Other Identifiers
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MENTIS-ASD002
Identifier Type: OTHER
Identifier Source: secondary_id
CR106701
Identifier Type: -
Identifier Source: org_study_id