Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

16. desember 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Autismespektrumforstyrrelse

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

186

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Arizona
  - Phoenix, Arizona, Forente stater
- California
  - San Francisco, California, Forente stater
- Connecticut
  - New Haven, Connecticut, Forente stater
- Massachusetts
  - Worcester, Massachusetts, Forente stater
- New Jersey
  - Toms River, New Jersey, Forente stater
- New York
  - Orangeburg, New York, Forente stater
- North Carolina
  - Durham, North Carolina, Forente stater
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater
- Washington
  - Seattle, Washington, Forente stater

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: up to Week 10		up to Week 10
Normative data on the JAKE Biosensor Array (Continuous and Periodic) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2015

Primær fullføring (Faktiske)

1. oktober 2016

Studiet fullført (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først innsendt

27. januar 2016

Først innsendt som oppfylte QC-kriteriene