Klinische proef op Autisme Spectrum Stoornis - Register voor klinische proeven

Studie Overzicht

Toestand

Voltooid

Conditie

Autisme Spectrum Stoornis

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

186

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Prospectief

Aantal groepen / cohorten

3

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2015

Primaire voltooiing (Werkelijk)

1 oktober 2016

Studie voltooiing (Werkelijk)

1 oktober 2016

Studieregistratiedata

Eerst ingediend

27 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria