【ChiCTR-IPR-17011233】對香港自閉症譜系兒童及其家庭進行正念訓練改善其健康狀况

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基本信息

登记号

ChiCTR-IPR-17011233

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

2017-04-24

临床申请受理号

靶点

适应症

Autism Spectrum Disorder

试验通俗题目

對香港自閉症譜系兒童及其家庭進行正念訓練改善其健康狀况

试验专业题目

對香港自閉症譜系兒童及其家庭進行正念訓練改善其健康狀况

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 goals of this project are to 1) reduce public stigma towards people and families with ASD and to improve the wellbeing of people and families with ASD in Hong Kong; 2) to evaluate the acceptability and effectiveness of a mindfulness training programme for adolescents with ASD and their parents for the first time in Hong Kong. The objectives of this project are to: 1) improve public awareness of ASD in Hong Kong 2) improve social responsiveness and reduce problem behaviours of adolescents with ASD 3) reduce parental stress and improve parenting style of parents of adolescents with ASD 4) develop and improve the expertise of health professionals in providing mindfulness interventions for adolescents with ASD.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

After the baseline visit, participants will be randomly assigned to one of the treatment groups by using a list of computer-generated random numbers. This generation of random numbers and assignment will be performed by an independent statistician.

盲法

The participants and instructors by nature will be informed of the randomisation allocation results, however, the trained research assistant/associate who conducts the assessments and the statistician who conducts the data analysis will be kept blinded of the grouping.

试验项目经费来源

FOOD AND HEALTH BUREAU, HONG KONG SAR

试验范围

目标入组人数

实际入组人数

第一例入组时间

2017-07-05

试验终止时间

2018-07-04

是否属于一致性

入选标准

The inclusion criteria of participants for the training will be children aged 12 to 18 years who have received a diagnosis of Autism Spectrum Disorders (ASD) by a doctor and also one of their parents agrees to participate in the MYmind training. Furthermore, if the child is on medication for ASD, the parents should have confirmed that they do not intend to change the medication status of their child during the study period. Parents will be asked to bring a copy of the ASD diagnosis of their children from a clinical doctor, usually a psychiatrist, for confirmation of the ASD diagnosis during the interview before they attend the MYmind training programme.；

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; 4) having substance dependence within the past 6 months, or a history of mental retardation, borderline and antisocial personality disorder, chronic suicidal and self-injurious behavior; or 5) participating in another ongoing psychological intervention.；

研究者信息

研究负责人姓名

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试验机构

HEALTH CARE AND PROMOTION FUND

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

联系人通讯地址

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