Clinical trial NCT02299700: Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
Official title: A Study to Preliminarily Assess the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Janssen Autism Knowledge Engine
Autism Spectrum Disorder
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Adult participants with history of Autism Spectrum Disorder will be observed.

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stage 1: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
timeFrame: Week 1
measure: Stage 2: Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
timeFrame: Week 4
Secondary outcomes:
measure: Utility of JAKE Symptom Tracker in Measuring Clinical Symptoms of ASD
timeFrame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
measure: Correlation Between Key Biosensors and ASD Symptoms
timeFrame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
measure: Ease of use and Utility of JAKE for use in Prospective Clinical Trials
timeFrame: Baseline and Week 1 in Stage 1, and Baseline and Week 4 in Stage 2
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 1 in Stage 1, and Up to Week 8 in Stage 2
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Toms River
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.