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Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort

16 dicembre 2016 aggiornato da: Janssen Research & Development, LLC

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

186

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti
    • California
      • San Francisco, California, Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti
    • Massachusetts
      • Worcester, Massachusetts, Stati Uniti
    • New Jersey
      • Toms River, New Jersey, Stati Uniti
    • New York
      • Orangeburg, New York, Stati Uniti
    • North Carolina
      • Durham, North Carolina, Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

6 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

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

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:

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

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
Lasso di tempo: 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.
up to Week 10

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
Lasso di tempo: up to Week 10
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.
up to Week 10
Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms
Lasso di tempo: up to Week 10
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).
up to Week 10
Correlation Between Genomic Characteristics and Autism Phenotypes
Lasso di tempo: up to Week 10
Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
up to Week 10
Usability of the JAKE System to detect changes in response to standard
Lasso di tempo: up to Week 10
Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
up to Week 10
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: up to Week 10
up to Week 10
Normative data on the JAKE Biosensor Array (Continuous and Periodic)
Lasso di tempo: up to Week 10
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.
up to Week 10
Normative data on the JAKE Task Battery
Lasso di tempo: up to Week 10
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.
up to Week 10
Ease of use of JAKE for use in Prospective Clinical Trials
Lasso di tempo: up to Week 10
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.
up to Week 10
Utility of JAKE for use in Prospective Clinical Trials
Lasso di tempo: up to Week 10
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.
up to Week 10

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2015

Completamento primario (Effettivo)

1 ottobre 2016

Completamento dello studio (Effettivo)

1 ottobre 2016

Date di iscrizione allo studio

Primo inviato

27 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2016

Primo Inserito (Stima)

29 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 dicembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR106701
  • MENTIS-ASD002 (Altro identificatore: Janssen Research & Development, LLC)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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