- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04879303
Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation
16 de agosto de 2021 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Eva Yin-han Chung, PhD
- Número de telefone: +852 29488233
- E-mail: chunge@eduhk.hk
Locais de estudo
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-
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Hong Kong, Hong Kong
- Recrutamento
- The Education University of Hong Kong
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Contato:
- Eva Yin-han Chung, PhD
- Número de telefone: +852 29488233
- E-mail: chunge@eduhk.hk
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
5 anos a 11 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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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Sem intervenção: Control
There will be no intervention conducted during the tested period
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Autism Diagnostic Observation Schedule
Prazo: 1 week before the intervention
|
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
Prazo: 1 week after the intervention
|
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
Prazo: 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
Prazo: 1 week after the intervention
|
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
Prazo: 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
Prazo: 1 week after the intervention
|
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
Prazo: 1 week before the intervention
|
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
Prazo: 1 week after the intervention
|
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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Eva Yin-han Chung, PhD, The Education University of Hong Kong
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de maio de 2021
Conclusão Primária (Antecipado)
1 de outubro de 2021
Conclusão do estudo (Antecipado)
30 de junho de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de maio de 2021
Primeira postagem (Real)
10 de maio de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de agosto de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de agosto de 2021
Última verificação
1 de agosto de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R1230
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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