【ChiCTR1800016591】A randomised controlled trial comparing MYmind with waitlist control among Chinese children with ADHD and their parents

查看原文

立即下载

基本信息

登记号

ChiCTR1800016591

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2018-06-11

临床申请受理号

靶点

适应症

注意力缺陷多動障礙

试验通俗题目

A randomised controlled trial comparing MYmind with waitlist control among Chinese children with ADHD and their parents

试验专业题目

A randomised controlled trial comparing MYmind with waitlist control among Chinese children with ADHD and their parents

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

1) To evaluate the effectiveness of a mindfulness-based intervention - MYmind - in improving children's attention, well-being, behaviour, resilience, family relationship and mindfulness level as well as reducing impulsivity associated with ADHD and health service use in children diagnosed with ADHD aged 8 to 18 years in Hong Kong. 2) To evaluate the effectiveness of MYmind in reducing parental stress and ADHD symptoms and improving well-being and rumination and reducing health service use among parents of children diagnosed with ADHD.

试验分类

请登录查看

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

目标入组人数

140

实际入组人数

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 children and one parent of each child. However, the other parent of the same child is also welcome to participate in the mindfulness course but only their course attendance will be recorded to reduce the burden of the participating families. The inclusion criteria will be: 1) children aged 8 to 18 years with psychiatrist or psychologist diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5) diagnostic criteria; and 2) with normal intellectual ability such that they can understand the materials delivered in MYmind and that they can complete home practice each week; and 3) children either not taking any medication or taking a stable dosage of the same medication for ADHD for at least 3 months prior to study enrolment and having no plan for changing medication during the study period.；

排除标准

The exclusion criteria of children and parents will be: 1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese; 2) the child having comorbid conduct/behavior problems which are so severe that, during intake, the interaction between parent and assessor is interrupted by the child within 2 minutes, which makes it impossible for the child to participate in a group training. Instructions of this criterion are adapted from the Autism Diagnostic Observation Schedule (ADOS) and will be provided to the assessor to facilitate to examine whether the child may be or may not be able to participate in a group training in addition to the clinicians expertise; 3) having a medical or mental health condition rendering him/her to be incapable of participating in the study; and 4) previous participation in mindfulness-based training.；

研究者信息

研究负责人姓名

请登录查看

试验机构

The D. H. Chen Foundation, Hong Kong SAR

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看