【ChiCTR1800018416】A randomised controlled trial for investigating the effectiveness of parent training on promoting physical activity in children with autism spectrum disorder

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基本信息

登记号

ChiCTR1800018416

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2018-09-17

临床申请受理号

靶点

适应症

自閉症譜系障礙

试验通俗题目

A randomised controlled trial for investigating the effectiveness of parent training on promoting physical activity in children with autism spectrum disorder

试验专业题目

A randomised controlled trial for investigating the effectiveness of parent training on promoting physical activity in children with autism spectrum disorder

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

852

联系人通讯地址

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临床试验信息

试验目的

- Compare the effectiveness and sustainability of an autism-focused exercise training programme that is either with or without the involvement of parents - Evaluate children's change of physical activity level, physical fitness, stereotypical and maladaptive behaviours before and after the training - Evaluate parenting-induced stress, parenting sense of competence, parent-child relationship and couples relationship satisfaction of parents before and after their children's participation of the exercise training programme - Evaluate the extent to which parental physical activity affects physical activity in children with ASD - Evaluate the extent to which parents' value to sport participation related to physical activity in children with ASD

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Using the stratified randomization, we will randomly identify multiple (ten schools in the first batch) schools in Hong Kong and then randomly select children formally diagnosed as ASD. Ten schools will be recruited and randomised into to groups.

盲法

The randomisation of the schools and the children with ASD will be generated by a statistician who is blinded to the study protocol.

试验项目经费来源

Research Grants Council, University Grants Committee, Hong Kong

试验范围

目标入组人数

实际入组人数

第一例入组时间

2018-12-01

试验终止时间

2021-06-30

是否属于一致性

入选标准

Children with ASD and their parents: Chinese children aged 7 to 9 years studying in the participating schools from primary school levels two to four, who have been clinically diagnosed with either autism, autistic features, ASD, Asperger syndrome or pervasive developmental disorder by developmental paediatricians or clinical psychologists based on the Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM-IV) and their parents will be invited to join the study.；

排除标准

Children with underlying congenital abnormalities or other diseases that limit their ability to engage in daily physical activities will be excluded.；

研究者信息

研究负责人姓名

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试验机构

General Research Fund, Research Grants Council, University Grants Committee, Hong Kong

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

852

联系人通讯地址