Autism Spectrum DisorderMentisNCT02299700
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2014to 24 Apr 2015
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and Adult participants with history of Autism Spectrum Disorder will be observed.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts
Study site
Durham, North Carolina
Study site
Toms River, New Jersey
About this study
Official title: A Study to Preliminarily Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
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).
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) 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- No Intervention
- Keywords
- Janssen Autism Knowledge Engine, Autism Spectrum Disorder
- 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.
No InterventionOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of Autism Spectrum Disorder (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, 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.
Measured: Week 1
Stage 2: 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, 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.
Measured: Week 4
Secondary outcomes (4)
Utility of JAKE Symptom Tracker in Measuring Clinical Symptoms of ASD
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.
Measured: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
Correlation Between Key Biosensors and 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 symptom tracker, and the event tracker).
Measured: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
Ease of use and 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, Symptom Tracker, Journal/ASD events, Treatment Tracker, Dashboard, HealthVault, Research Data Warehouse and Workbench.
Measured: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Up to Week 1 in Stage 1, and Up to Week 8 in Stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start30 Sep 2014
- Primary completion24 Apr 2015
- Study completion24 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 34 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
- NCT02299700
- Sponsor's protocol ID
- CR104919
- Other IDs
- ASD-001
- Acronym
- Mentis
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2014
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Chatterjee M, Manyakov NV, Bangerter A, Kaliukhovich DA, Jagannatha S, Ness S, Pandina G. Learning Scan Paths of Eye Movement in Autism Spectrum Disorder. Stud Health Technol Inform. 2020 Jun 16;270:287-291. doi: 10.3233/SHTI200168.
PubMed 32570392Bangerter A, Chatterjee M, Manfredonia J, Manyakov NV, Ness S, Boice MA, Skalkin A, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Automated recognition of spontaneous facial expression in individuals with autism spectrum disorder: parsing response variability. Mol Autism. 2020 May 11;11(1):31. doi: 10.1186/s13229-020-00327-4.
PubMed 32393350Bangerter A, Ness S, Lewin D, Aman MG, Esbensen AJ, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Opler M, Ho KF, Pandina G. Clinical Validation of the Autism Behavior Inventory: Caregiver-Rated Assessment of Core and Associated Symptoms of Autism Spectrum Disorder. J Autism Dev Disord. 2020 Jun;50(6):2090-2101. doi: 10.1007/s10803-019-03965-7.
PubMed 30888551Manfredonia J, Bangerter A, Manyakov NV, Ness S, Lewin D, Skalkin A, Boice M, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Automatic Recognition of Posed Facial Expression of Emotion in Individuals with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Jan;49(1):279-293. doi: 10.1007/s10803-018-3757-9.
PubMed 30298462Manyakov NV, Bangerter A, Chatterjee M, Mason L, Ness S, Lewin D, Skalkin A, Boice M, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Visual Exploration in Autism Spectrum Disorder: Exploring Age Differences and Dynamic Features Using Recurrence Quantification Analysis. Autism Res. 2018 Nov;11(11):1554-1566. doi: 10.1002/aur.2021. Epub 2018 Oct 1.
PubMed 30273450Ness SL, Manyakov NV, Bangerter A, Lewin D, Jagannatha S, Boice M, Skalkin A, Dawson G, Janvier YM, Goodwin MS, Hendren R, Leventhal B, Shic F, Cioccia W, Pandina G. JAKE(R) Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder. Front Neurosci. 2017 Sep 26;11:517. doi: 10.3389/fnins.2017.00517. eCollection 2017.
PubMed 29018317
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Preliminarily Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02299700
- Acronym / sponsor ID
- Mentis / CR104919
- Conditions
- Autism Spectrum Disorder
- Keywords
- Janssen Autism Knowledge Engine, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 24 Nov 2014 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) Participants (6-9 years) | – | Other: No InterventionParticipants 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). |
| ASD Participants (13-17 years) | – | Other: No InterventionParticipants 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). |
| ASD Participants (3 or greater than 3 years) | – | Other: No InterventionParticipants 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). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and Adult participants with history of Autism Spectrum Disorder will be observed.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThe usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in Autism Spectrum Disorder (ASD) will be observed. | Other | ASD Participants (13-17 years), ASD Participants (3 or greater than 3 years), Autism Spectrum Disorder (ASD) Participants (6-9 years) |
Primary outcome
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.
4 secondary outcomes
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
Correlation Between Key Biosensors and ASD Symptoms
Time frame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
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
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
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 23 Oct 2017.
- Derived from this study: PubMed 32570392Chatterjee M, Manyakov NV, Bangerter A, Kaliukhovich DA, Jagannatha S, Ness S, Pandina G. Learning Scan Paths of Eye Movement in Autism Spectrum Disorder. Stud Health Technol Inform. 2020 Jun 16;270:287-291. doi: 10.3233/SHTI200168.
- Derived from this study: PubMed 32393350Bangerter A, Chatterjee M, Manfredonia J, Manyakov NV, Ness S, Boice MA, Skalkin A, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Automated recognition of spontaneous facial expression in individuals with autism spectrum disorder: parsing response variability. Mol Autism. 2020 May 11;11(1):31. doi: 10.1186/s13229-020-00327-4.
- Derived from this study: PubMed 30888551Bangerter A, Ness S, Lewin D, Aman MG, Esbensen AJ, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Opler M, Ho KF, Pandina G. Clinical Validation of the Autism Behavior Inventory: Caregiver-Rated Assessment of Core and Associated Symptoms of Autism Spectrum Disorder. J Autism Dev Disord. 2020 Jun;50(6):2090-2101. doi: 10.1007/s10803-019-03965-7.
- Derived from this study: PubMed 30298462Manfredonia J, Bangerter A, Manyakov NV, Ness S, Lewin D, Skalkin A, Boice M, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Automatic Recognition of Posed Facial Expression of Emotion in Individuals with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Jan;49(1):279-293. doi: 10.1007/s10803-018-3757-9.
- Derived from this study: PubMed 30273450Manyakov NV, Bangerter A, Chatterjee M, Mason L, Ness S, Lewin D, Skalkin A, Boice M, Goodwin MS, Dawson G, Hendren R, Leventhal B, Shic F, Pandina G. Visual Exploration in Autism Spectrum Disorder: Exploring Age Differences and Dynamic Features Using Recurrence Quantification Analysis. Autism Res. 2018 Nov;11(11):1554-1566. doi: 10.1002/aur.2021. Epub 2018 Oct 1.
- Derived from this study: PubMed 29018317Ness SL, Manyakov NV, Bangerter A, Lewin D, Jagannatha S, Boice M, Skalkin A, Dawson G, Janvier YM, Goodwin MS, Hendren R, Leventhal B, Shic F, Cioccia W, Pandina G. JAKE(R) Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder. Front Neurosci. 2017 Sep 26;11:517. doi: 10.3389/fnins.2017.00517. eCollection 2017.
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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
3 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 3 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 6 inclusion and 5 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Stage 1: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) (time frame: Week 1). The study lists 2 primary outcomes in all. 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 NCT02299700, which also lists 6 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 23 Oct 2017.