Autism Spectrum DisorderNCT02668991
Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
An observational study of Autism Spectrum Disorder, run by Janssen Research & Development, LLC at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 186 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and Adult participants with history of Autism Spectrum Disorder (ASD) will be observed.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Durham, North Carolina
Study site
New Haven, Connecticut
Study site
Orangeburg, New York
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Toms River, New Jersey
Study site
Worcester, Massachusetts
About this study
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
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Janssen Autism Knowledge Engine, Autism Behavior Inventory
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
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.
Measured: up to Week 10
Secondary outcomes (9)
Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
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.
Measured: up to Week 10
Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms
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).
Measured: up to Week 10
Correlation Between Genomic Characteristics and Autism Phenotypes
Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
Measured: up to Week 10
Usability of the JAKE System to detect changes in response to standard
Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
Measured: up to Week 10
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: up to Week 10
Normative data on the JAKE Biosensor Array (Continuous and Periodic)
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.
Measured: up to Week 10
Normative data on the JAKE Task Battery
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.
Measured: up to Week 10
Ease of use of JAKE for use in Prospective Clinical Trials
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.
Measured: up to Week 10
Utility of JAKE for use in Prospective Clinical Trials
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.
Measured: up to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668991
- Sponsor's protocol ID
- CR106701
- Other IDs
- MENTIS-ASD002
- Status last verified
- Dec 2016
- First submitted
- 27 Jan 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34623583Kaliukhovich 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.
PubMed 33076994Bangerter 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.
PubMed 30912762Ness 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.
PubMed 30872988
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02668991
- Acronym / sponsor ID
- CR106701
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Janssen Autism Knowledge Engine, Autism Behavior Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and Adult participants with history of Autism Spectrum Disorder (ASD) will be observed.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
9 secondary outcomes
Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
Time frame: up to Week 10
Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms
Time frame: up to Week 10
Correlation Between Genomic Characteristics and Autism Phenotypes
Time frame: up to Week 10
Usability of the JAKE System to detect changes in response to standard
Time frame: up to Week 10
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 Task Battery
Time frame: up to Week 10
Ease of use of JAKE for use in Prospective Clinical Trials
Time frame: up to Week 10
Utility of JAKE for use in Prospective Clinical Trials
Time frame: up to Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Derived from this study: PubMed 34623583Kaliukhovich 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.
- Derived from this study: PubMed 33076994Kaliukhovich 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.
- Derived from this study: PubMed 30912762Bangerter 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.
- Derived from this study: PubMed 30872988Ness 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Janssen Research & Development, LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) (time frame: up to Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668991, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.