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- Ensaio Clínico NCT02235467
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.
Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.
Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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São Paulo, Brasil, 04038-030
- Federal University of São Paulo Department of Psychiatry
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Clinical Diagnosis of Autism Spectrum Disorders
- Diagnosis of Autism Spectrum Disorders by means of ADI
- IQ equal or lower than 70 by means of SON
- Main caregiver's level of education > primary education
Exclusion Criteria:
- IQ lower than 50 by means of SON
- Child who is receiving ABA therapy at least 10 hours per week
- Main caregiver diagnosed with Autism Spectrum Disorders
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
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A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Outros nomes:
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Sem intervenção: ABA parent training control
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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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Acquisition from baseline of new behaviors at 8 weeks
Prazo: baseline assessment to 8 weeks of therapy
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acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
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baseline assessment to 8 weeks of therapy
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Acquisition from baseline of new behaviors at 16 weeks
Prazo: baseline assessment to 16 weeks
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acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline assessment to 16 weeks
|
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Acquisition from baseline of new behaviors at 21 weeks
Prazo: baseline to 21 weeks
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
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baseline to 21 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Eye-tracking at 21 weeks
Prazo: baseline assessment to 21 weeks
|
Latency, duration, and sequence of visual fixations measured with eye-tracking
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baseline assessment to 21 weeks
|
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Change from baseline in Vineland Scale at 21 weeks
Prazo: baseline assessment to 21 weeks
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Adaptative behavior using Vineland Scale
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baseline assessment to 21 weeks
|
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Change from baseline in SON-R 2½-7 at 21 weeks
Prazo: baseline assessment to 21 weeks
|
Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
|
baseline assessment to 21 weeks
|
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Change from baseline in Zaritt Burden Interview at 21 weeks
Prazo: baseline assessment to 21 weeks
|
The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
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baseline assessment to 21 weeks
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Change from baseline in OERA at 21 weeks
Prazo: baseline assessment to 21 weeks
|
OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
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baseline assessment to 21 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in KAP at 21 weeks
Prazo: baseline assessment to 21 weeks
|
Improvement on the knowledge, attitude and practice (KAP) questionnaire
|
baseline assessment to 21 weeks
|
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Change from baseline in Hamilton scalels and at 21 weeks
Prazo: baseline assessment to 21 weeks
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Improvement on the Hamilton Depression and Anxiety scales of the caregiver
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baseline assessment to 21 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Sheila C Caetano, MD, PhD, Federal University of São Paulo, São Paulo, Brazil
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- U1111-1157-8984
- 2012/51584-0 (Número de outro subsídio/financiamento: FAPESP)
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