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- Ensaio Clínico NCT03700190
The Predictors for Activity and Participation in Children With ASD: A Follow-up Study
17 de fevereiro de 2022 atualizado por: Chang Gung Memorial Hospital
Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
Most ASD studies have explored the body functions and core symptoms in children with ASD by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages.
Although studies explore many predictors to predict the activities and participation in children with ASD, but less studies explore sensory perception to predict the activities and participation in children with ASD.
Tipo de estudo
Observacional
Inscrição (Antecipado)
180
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.
Locais de estudo
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Taoyuan, Taiwan, 333
- Recrutamento
- Chang Gung Memorial Hospital
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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
2 anos a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
This study is a prospective and follow-up study.
Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.
Descrição
Inclusion Criteria:
- Patients with Autism Spectrum Disorder
- Age 2-18 y/o
- Agree to sign informed consent
Exclusion Criteria:
- Active medical condition (e.g. infection)
- Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
- Concurrent illness or disease not typically associated with ASD (e.g. pneumonia)
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
Coortes e Intervenções
Grupo / Coorte |
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Ao controle
Criança saudável
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Experimental
Patients with Autism Spectrum Disorder
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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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Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Comprehensive Developmental Inventory for Infants and Toddlers
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baseline, 6 months, 12 months
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Change from baseline of body function & structures in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Bruininks- Oseretsky Test of Motor Proficiency II short form
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baseline, 6 months, 12 months
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Change from baseline of Sensory and Perceptual function in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Sensory Profile:It is composed of 125 projects and is completed by the main caregivers of children.
There are 14 sub-projects, which can be divided into three main areas: sensory processing (6 items), adjustment (5 items), and emotional response ( 3 items), the project score is divided into 0, 25, 50, 75, 100% (none, rarely, occasionally, often, almost always)
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baseline, 6 months, 12 months
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Change from baseline of Participation in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Children Assessment of Participation and Enjoyment(CAPE): Applicable to children or adolescents between the ages of six and twenty one, through questionnaires through self-reports or interviews, a total of 49 questions, asking children about the activities involved in the past four months (1 point for yes, 0 for no).
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baseline, 6 months, 12 months
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Change from baseline of Participation in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level.
There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).
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baseline, 6 months, 12 months
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Change from baseline of Visual Perception in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Test of Visual Perceptual Skills-Third Edition
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baseline, 6 months, 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline of lower extremity function & structures in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Pediatric Balance Scale:The Pediatric Balance Scale (PBS) is a 14-item measure of functional balance for children, ages 2 to 13 years.
It was developed through modifications of the Berg Balance Scale to identify children who lack appropriate functional balance and thus may be at risk for developmental delay and injury.
The PBS is also used to identify change in functional balance with intervention.
The score for each item is from 0 (lowest function) to 4 (highest function).
The total maximum score that refers to the best function, is 56.
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baseline, 6 months, 12 months
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Change from baseline of activities in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Functional Independence Measure for Children:Applicable to infants and adolescents.
The main purpose is to understand and track children's life function performance, progress and goal achievement.
There are three main areas: self-care, mobility, and cognition.
The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.
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baseline, 6 months, 12 months
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Change from baseline of Quality of Life in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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TNO-AZL Child Quality of Life Questionnaire (TACQOL): The TACQOL is for children aged from 8 to 15.
The questionnaire can be done by the parents or the children themselves for children's health status.
The TACQOL contains 56 items with 7 domains (physical functioning, motor, autonomous, cognitive, social, positive moods, and negative moods).
There are 8 items in each domain.
For physical functioning, motor, autonomous, cognitive and social domains, the scoring is from 0 (never) to 3 (often), followed by a question of child's feeling (3: fine, 2: not so good, 1: quite bad or 0: bad).
Items are scored by assigning a value of 4 to the 'never' response, a value of 3 to a 'feeling fine' response, a value of 2 to a 'feeling not so good' response, a value of 1 to a 'feeling quite bad' response and a value of 0 to a 'feeling bad' response.
For moods, the scoring is from 0 (never) to 3 (often).
The minimal score is 0, and the maximal score is 219.
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baseline, 6 months, 12 months
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Change from baseline of Personal & Environment factor in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Parenting Stress Index:Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior.
Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress.
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baseline, 6 months, 12 months
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Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Measure of Processes of Care: It is to assess parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers.
It is a means to assess family-centered behaviors of health care providers.
There are 20 items.
For each item, a question begins with "To what extent do the people who work with your child," with a 7-point scale with the statement "the service provider engaged in this behavior to a very great extent" (7 point) and "not at all" (1 point).
0 point refers to "not applicable.
For each item, the minimal score is 0, and the maximum is 7.
A scale score is obtained by calculating the average of the items' ratings.
There is no total score.
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baseline, 6 months, 12 months
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Change from baseline of Social Responsiveness Scale in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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his scale is suitable for children aged 4-18.
It is evaluated by 65 questions whether there is a social disorder.
The child is identified as autism.
The score is 0-3, 0 is untrue, and 3 is descriptive.
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baseline, 6 months, 12 months
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Change from baseline of facial expression in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Taiwanese facial expression database:According to Yangming University database, select black and white pictures, strong expression versions, and select five questions of happiness, anger, sadness, fear, and neutrality, a total of 20 questions, each question is taken in four ways, each emotion is in each question will only appear at most, and will be randomly distributed and presented on the computer.
The child will specify the specified mood, 1 point for each question, up to 20 points.
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baseline, 6 months, 12 months
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Change from baseline of Clancy Behavior Scale in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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This scale is suitable for children aged 2-5, a total of 14 questionnaires, about 10 minutes of test, mainly used to screen children with autism, three-point scoring, 2 points for frequent, 1 for occasional, 0 for No, the total score is greater than 14 and there is a tendency to autism.
If the score is more than 2/3, it is established as a child with autism.
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baseline, 6 months, 12 months
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Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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A questionnaire for assessing children's social cognition ability, which is a five-point questionnaire for continuity.
It can be filled out by parents or filled by children with good reading skills and speaking skills.
This scale is suitable for children aged 2-13, including 60 items.
Each question is described as a state, including emotional cognition, mental state understanding, pragmatics and other fields.
The person who fills the document is marked with "not", "may not "undetermined", "may have", "determined"
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baseline, 6 months, 12 months
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Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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Applicable to children under the age of six and those with insufficient intelligence or suspected communication at the age of six, used to judge whether children have autism.
A total of 15 questions, each topic is divided into 1 to 4 points, the highest total score of 60 points.
For high-function groups, the total score <27.5, non-autistic; between 28 and 33.5 points, there is a tendency to autism; >33.5 points, there is autism.
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baseline, 6 months, 12 months
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Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months
Prazo: baseline, 6 months, 12 months
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This is a set of questionnaires for screening autism traits (social impairment, communication deficit, repetitive behavior) for children with Asperger or high-functioning autism.
It is suitable for children aged 4-11 years.
The questionnaire is filled out by parents and filled out.
The time is about 10 minutes, divided into two points (0, 1 points), a total of 37 questions
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baseline, 6 months, 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
1 de agosto de 2017
Conclusão Primária (Antecipado)
31 de julho de 2022
Conclusão do estudo (Antecipado)
31 de outubro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de outubro de 2018
Primeira postagem (Real)
9 de outubro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de fevereiro de 2022
Última verificação
1 de fevereiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201601949B0
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
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .