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【ChiCTR1800016588】Mindfulness based intervention for Chinese children with autism and their parents: a randomised controlled trial

基本信息
登记号

ChiCTR1800016588

试验状态

正在进行

药物名称

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药物类型

/

规范名称

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首次公示信息日的期

2018-06-11

临床申请受理号

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靶点

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适应症

孤獨症譜系障礙

试验通俗题目

Mindfulness based intervention for Chinese children with autism and their parents: a randomised controlled trial

试验专业题目

Mindfulness based intervention for Chinese children with autism and their parents: a randomised controlled trial

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

联系人通讯地址
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临床试验信息
试验目的

The objective of this randomized controlled trial is to examine the effectiveness of a mindfulness-based intervention specifically developed for children with ASD aged 8 to 18 years on their well-being, autism-related symptoms, behaviours, resilience, family relationship, mindfulness level and health service utilization, as well as their parents parental stress, well being, rumination, and health service utilization in Hong Kong, comparing to waiting list control.

试验分类
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试验类型

随机平行对照

试验分期

治疗新技术

随机化

The randomisation will be conducted by an experienced independent statistician using computer-generated random results.

盲法

Participants will be informed of their group assignments. The research staff member who conducts the assessments or the statistical analysis will be kept blinded of the group assignment.

试验项目经费来源

The D. H. Chen Foundation, Hong Kong SAR

试验范围

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目标入组人数

140

实际入组人数

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第一例入组时间

2018-06-28

试验终止时间

2021-06-27

是否属于一致性

/

入选标准

Participants will include both children with ASD and their parents. The inclusion criteria will be (1) children aged 8-18 years who have been previously diagnosed with ASD by a doctor according to the Diagnostic and Statistical Manual of Mental Disorders-4/5 (DSM-4/5) diagnostic criteria; (2) and at least one of their parents agrees to participate.;

排除标准

The exclusion criteria will be: (1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese; (2) having a medical condition rendering him/her to be incapable to participate in the study; (3) unwilling or unable to give consent.;

研究者信息
研究负责人姓名
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试验机构

The D. H. Chen Foundation, Hong Kong SAR

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研究负责人邮编

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