Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
16 de agosto de 2021 actualizado por: Eva Chung Yin-han, Education University of Hong Kong
This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context.
The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework.
Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework.
Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework.
With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
60
Fase
- No aplica
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.
Estudio Contacto
- Nombre: Eva Yin-han Chung, PhD
- Número de teléfono: +852 29488233
- Correo electrónico: chunge@eduhk.hk
Ubicaciones de estudio
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Hong Kong, Hong Kong
- Reclutamiento
- The Education University of Hong Kong
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Contacto:
- Eva Yin-han Chung, PhD
- Número de teléfono: +852 29488233
- Correo electrónico: chunge@eduhk.hk
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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
5 años a 11 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- clinical diagnosis of autism spectrum disorder
- aged between 5-11
- normal intelligence
Exclusion Criteria:
- with self-injurious or aggressive behavior
- with hearing or visual impairment
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Robot-assisted social skill intervention
Social robotics will be used by the instructor to conduct the social skill training activities.
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Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
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Comparador activo: Human-only instruction program on social skill training
The children will receive only the human-delivered social skill training.
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The children will receive only the human-delivered training throughout the 12 sessions, with the content and sequence of activities the same as the robotic intervention group.
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Sin intervención: Control
There will be no intervention conducted during the tested period
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Autism Diagnostic Observation Schedule
Periodo de tiempo: 1 week before the intervention
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The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play.
It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment.
The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed.
It is individual-based and will take 30-45 minutes for administering.
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1 week before the intervention
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The Autism Diagnostic Observation Schedule
Periodo de tiempo: 1 week after the intervention
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The Autism Diagnostic Observation Schedule (ADOS) is a play-based standardized protocol for observing interaction, communication, repetitive behavior and play.
It has a standardized algorithm score on communication and reciprocal social interaction domains that can contribute to diagnosis and to measure change in autistic symptoms during treatment.
The ADOS creates an interactive play environment in which the children's social behaviors, use of speech and gestures in social situations can be observed.
It is individual-based and will take 30-45 minutes for administering.
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1 week after the intervention
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Social Responsiveness Scale
Periodo de tiempo: 1 week before the intervention
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The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items.
It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
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1 week before the intervention
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Social Responsiveness Scale
Periodo de tiempo: 1 week after the intervention
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The Social Responsiveness Scale (SRS) is a questionnaire which is comprised of 65 items.
It systematically collects information on parents' reports of their children's social awareness, cognition, communication, motivation and mannerisms.
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1 week after the intervention
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The Canadian Occupational Performance Measure
Periodo de tiempo: 1 week before the intervention
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The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation.
It will collect both quantitative and qualitative data.
The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
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1 week before the intervention
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The Canadian Occupational Performance Measure
Periodo de tiempo: 1 week after the intervention
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The Canadian Occupational Performance Measure (COPM) is a validated tool for measuring outcomes of intervention programs on activity participation.
It will collect both quantitative and qualitative data.
The performance score and satisfaction score on participation of activities will be collected both before and after the intervention to reveal the change of the client throughout the intervention.
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1 week after the intervention
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Short sensory profile
Periodo de tiempo: 1 week before the intervention
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The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks.
This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses.
Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
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1 week before the intervention
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Short sensory profile
Periodo de tiempo: 1 week after the intervention
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The Short Sensory Profile is a validated assessment tool to capture sensory processing behaviors that indicate a low or high threshold to sensory experiences resulting in interference with the performance of daily living tasks.
This parent-reported measure is scored on six sensory systems and two behavioral category subscales, namely auditory processing, visual processing, taste and smell processing, body position, movement, touch processing, activity level, and social and emotional responses.
Item scores can be calculated and aggregated into the seven factor scores: emotionally reactive, sensory sensitivity, low registration, sensory seeking, sensory defensiveness, oral sensory seeking, and low endurance.
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1 week after the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Eva Yin-han Chung, PhD, The Education University of Hong Kong
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 (Actual)
3 de mayo de 2021
Finalización primaria (Anticipado)
1 de octubre de 2021
Finalización del estudio (Anticipado)
30 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
19 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2021
Publicado por primera vez (Actual)
10 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R1230
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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