Klinisk prövning på Autismspektrumstörning - Kliniska prövningsregister

Studieöversikt

Status

Avslutad

Betingelser

Autismspektrumstörning

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

186

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Antal grupper/kohorter

3

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD) Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2015

Primärt slutförande (Faktisk)

1 oktober 2016

Avslutad studie (Faktisk)

1 oktober 2016

Studieregistreringsdatum

Först inskickad

27 januari 2016

Först inskickad som uppfyllde QC-kriterierna