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

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
申请人名称
联系人邮箱
联系人邮编

852

联系人通讯地址
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
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

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目标入组人数

30

实际入组人数

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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
试验机构

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

研究负责人电话
研究负责人邮箱
研究负责人邮编

852

联系人通讯地址
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