Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
16 de diciembre de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
De observación
Inscripción (Actual)
186
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos
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California
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San Francisco, California, Estados Unidos
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Connecticut
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New Haven, Connecticut, Estados Unidos
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Massachusetts
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Worcester, Massachusetts, Estados Unidos
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New Jersey
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Toms River, New Jersey, Estados Unidos
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New York
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Orangeburg, New York, Estados Unidos
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North Carolina
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Durham, North Carolina, Estados Unidos
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
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Washington
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Seattle, Washington, Estados Unidos
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Children and Adult participants with history of Autism Spectrum Disorder (ASD) will be observed.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Utility of Autism Behavior Inventory(ABI) in Measuring Clinical Symptoms of Autism Spectrum Disorder (ASD)
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Usability of the Janssen Autism Knowledge Engine (JAKE) in Measuring Clinical Symptoms of ASD
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Correlation Between Key Biosensors and Autism Spectrum Disorder (ASD) Symptoms
Periodo de tiempo: up to Week 10
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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).
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up to Week 10
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Correlation Between Genomic Characteristics and Autism Phenotypes
Periodo de tiempo: up to Week 10
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Genomic analysis will be done by analyzing DNA samples related to the JAKE System or autism spectrum disorder.
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up to Week 10
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Usability of the JAKE System to detect changes in response to standard
Periodo de tiempo: up to Week 10
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Change is symptoms in response to coincident courses of treatment with standard behavioral therapy as measured with the JAKE system.
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up to Week 10
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: up to Week 10
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up to Week 10
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Normative data on the JAKE Biosensor Array (Continuous and Periodic)
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Normative data on the JAKE Task Battery
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Ease of use of JAKE for use in Prospective Clinical Trials
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Utility of JAKE for use in Prospective Clinical Trials
Periodo de tiempo: up to Week 10
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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.
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up to Week 10
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Kaliukhovich DA, Manyakov NV, Bangerter A, Pandina G. Context Modulates Attention to Faces in Dynamic Social Scenes in Children and Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2022 Oct;52(10):4219-4232. doi: 10.1007/s10803-021-05279-z. Epub 2021 Oct 8.
- Kaliukhovich DA, Manyakov NV, Bangerter A, Ness S, Skalkin A, Goodwin MS, Dawson G, Hendren RL, Leventhal B, Hudac CM, Bradshaw J, Shic F, Pandina G. Social attention to activities in children and adults with autism spectrum disorder: effects of context and age. Mol Autism. 2020 Oct 19;11(1):79. doi: 10.1186/s13229-020-00388-5.
- Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Ness S, Pandina G. Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps. JMIR Ment Health. 2019 Mar 26;6(3):e11365. doi: 10.2196/11365.
- Ness SL, Bangerter A, Manyakov NV, Lewin D, Boice M, Skalkin A, Jagannatha S, Chatterjee M, Dawson G, Goodwin MS, Hendren R, Leventhal B, Shic F, Frazier JA, Janvier Y, King BH, Miller JS, Smith CJ, Tobe RH, Pandina G. An Observational Study With the Janssen Autism Knowledge Engine (JAKE(R)) in Individuals With Autism Spectrum Disorder. Front Neurosci. 2019 Feb 27;13:111. doi: 10.3389/fnins.2019.00111. eCollection 2019.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2015
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
27 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
27 de enero de 2016
Publicado por primera vez (Estimar)
29 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
16 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR106701
- MENTIS-ASD002 (Otro identificador: Janssen Research & Development, LLC)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .