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

NCT02299700 | Completed

• 2 other identifiers: CR104919ASD-001
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 3

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).

Conditions

Autism Spectrum Disorder

Keywords

Janssen Autism Knowledge Engine; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 4

Secondary Outcomes (4)

• Utility of JAKE Symptom Tracker in Measuring Clinical Symptoms of ASD

  Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2

• Correlation Between Key Biosensors and ASD Symptoms

  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

  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)

  Up to Week 1 in Stage 1, and Up to Week 8 in Stage 2

Study Arms (3)

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).

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).

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).

Other: No Intervention

Interventions

No Intervention OTHER

The usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in Autism Spectrum Disorder (ASD) will be observed.

ASD Participants (13-17 years); ASD Participants (3 or greater than 3 years); Autism Spectrum Disorder (ASD) Participants (6-9 years)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and Adult participants with history of Autism Spectrum Disorder will be observed.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Toms River, New Jersey, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Related Publications (6)

• 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.

  PMID: 32570392 DERIVED

• Bangerter 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.

  PMID: 32393350 DERIVED

• Bangerter 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.

  PMID: 30888551 DERIVED

• Manfredonia 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.

  PMID: 30298462 DERIVED

• Manyakov 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.

  PMID: 30273450 DERIVED

• Ness 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.

  PMID: 29018317 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: November 24, 2014
• Study Start: September 30, 2014
• Primary Completion: April 24, 2015
• Study Completion: April 24, 2015
• Last Updated: October 23, 2017

Record last verified: 2017-10

Locations

US (3)