【ChiCTR1800014741】The effects of a mindfulness based intervention - MYmind - for children with ADHD and their parents: a randomised controlled trial

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基本信息

登记号

ChiCTR1800014741

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

2018-01-31

临床申请受理号

靶点

适应症

注意缺陷多動障礙症

试验通俗题目

The effects of a mindfulness based intervention - MYmind - for children with ADHD and their parents: a randomised controlled trial

试验专业题目

The effects of a mindfulness based intervention - MYmind - for children with ADHD and their parents: a randomised controlled trial

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临床试验信息

试验目的

1. To evaluate the effectiveness of a mindfulness based intervention - MYmind - in improving childrens attention, behaviour and executive function as well as reducing impulsivity associated with ADHD in children diagnosed with ADHD aged 8 to 12 years in Hong Kong; 2. To evaluate the effectiveness of MYmind in reducing parental stress and ADHD symptoms and improving well-being and parenting style among parents of children diagnosed with ADHD; 3. To further evaluate the acceptability of MYmind for children diagnosed with ADHD and their parents in Hong Kong Chinese.

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 in an 1:1 ratio with computer-generated random numbers.

盲法

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

试验项目经费来源

General Research Fund, University Grants Committee, 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

2018-01-01

试验终止时间

2020-12-31

是否属于一致性

入选标准

1) children aged 8 to 12 years with psychiatrist or psychologist diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5) diagnostic criteria and ADHD status being re-confirmed by clinically elevated inattentive and/or hyperactive-impulsive symptoms as indicated by T-scores of either parent and teacher versions of Strengths and Weaknesses of ADHD-symptoms and Normal-behaviour (SWAN, Chinese version) at or above 95th percentile, or both parent and teacher versions of the SWAN (Chinese version) at or above 85th percentile; 2) with normal intellectual ability such that they can understand the materials delivered in MYmind and that they can complete home practice each week; 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 are: 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 clinician 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 clinician 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; 4) previous participation in mindfulness-based training.；

研究者信息

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试验机构

General Research Fund, University Grants Committee, Hong Kong SAR

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