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

Registration number：

 ChiCTR1800014741 

最近更新日期：

Date of Last Refreshed on：

 2018-02-01 19:41:05 

注册时间：

Date of Registration：

 2018-01-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

MYmind for ADHD

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Daisy Dexing ZHANG 

研究负责人：

Prof. Samuel Yeungshan WONG 

Applicant：

Daisy Dexing ZHANG 

Study leader：

Prof. Samuel Yeungshan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 22528764

研究负责人电话：

Study leader's
telephone：

+852 22528774

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhangdxdaisy@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中國香港沙田香港中文大學威爾士親王醫院公共衛生和初級保健學院

研究负责人通讯地址：

中國香港沙田香港中文大學威爾士親王醫院公共衛生和初級保健學院

Applicant address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學威爾士親王醫院公共衛生和初級保健學院

Applicant's institution：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學威爾士親王醫院公共衛生和初級保健學院

Affiliation of the Leader：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 CREC 2015.193

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-06-01 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

中國香港沙田香港中文大學威爾斯親王醫院呂志和臨床科學大樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

General Research Fund, University Grants Committee, Hong Kong SAR

Primary sponsor：

General Research Fund, University Grants Committee, Hong Kong SAR

研究实施负责（组长）单位地址：

中國香港灣仔海港路6-8號瑞安中心7/F

Primary sponsor's address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

General Research Fund, University Grants Committee, Hong Kong SAR

Source(s) of funding：

General Research Fund, University Grants Committee, Hong Kong SAR

研究疾病：

注意缺陷多動障礙症  

Target disease：

Attention Deficit Hyperactivity Disorder (ADHD)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

The intervention is a mindfulness based intervention program (MYmind) specifically designed for children with ADHD and their parents. It has 8 weekly sessions with homework.  

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2018-01-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-02-01 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 140

Group：

1

Sample size：

干预措施：

Mindfulness-based Intervention (MYmind)

干预措施代码：

Intervention：

Mindfulness-based Intervention (MYmind)

Intervention code：

组别：

2

样本量：

 140

Group：

2

Sample size：

干预措施：

Cognitive Behavioral Therapy (CBT)

干预措施代码：

Intervention：

Cognitive Behavioral Therapy (CBT)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Child and Family Services 

单位级别：

 NGOs & Community 

Institution
hospital：

Child and Family Services

Level of the institution：

NGOs & Community

测量指标：

Outcomes：

指标中文名：

The attention score of the subtest Sky Search of TEA-Ch (for children)

指标类型：

主要指标

Outcome：

The attention score of the subtest Sky Search of TEA-Ch (for children)

Type：

Primary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

Assessed by trained personnel

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

Assessed by trained personnel

指标中文名：

Creature Counting, Opposite Worlds, and Code Transmission subtests of TEA-Ch (for children)

指标类型：

次要指标

Outcome：

Creature Counting, Opposite Worlds, and Code Transmission subtests of TEA-Ch (for children)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

Assessed by trained personnel

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

Assessed by trained personnel

指标中文名：

Child attention network test (ANT) (for children)

指标类型：

次要指标

Outcome：

Child attention network test (ANT) (for children)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

computer-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

computer-based test

指标中文名：

The Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours (SWAN) Rating Scale (for children)

指标类型：

次要指标

Outcome：

The Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours (SWAN) Rating Scale (for children)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

The Eyberg Child Behaviour Inventory (ECBI) (for children)

指标类型：

次要指标

Outcome：

The Eyberg Child Behaviour Inventory (ECBI) (for children)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

The Behavior Rating Inventory of Executive Function (BRIEF) (for children)

指标类型：

次要指标

Outcome：

The Behavior Rating Inventory of Executive Function (BRIEF) (for children)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

Parenting Stress Index (PSI) (for parents)

指标类型：

次要指标

Outcome：

Parenting Stress Index (PSI) (for parents)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

Rumination Response Scale (RRS)

指标类型：

次要指标

Outcome：

Rumination Response Scale (RRS)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

Adult ADHD Self-Report Scale (ASRS) (for parents)

指标类型：

次要指标

Outcome：

Adult ADHD Self-Report Scale (ASRS) (for parents)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

The WHO (Five) Well-Being Index (WHO-5) (for parents)

指标类型：

次要指标

Outcome：

The WHO (Five) Well-Being Index (WHO-5) (for parents)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

Child and Adolescent Mindfulness Measure (CAMM)

指标类型：

次要指标

Outcome：

Child and Adolescent Mindfulness Measure (CAMM)

Type：

Secondary indicator

测量时间点：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

测量方法：

paper-based test

Measure time point of outcome：

baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)

Measure method：

paper-based test

指标中文名：

Perceived levels of easiness, usefulness and satisfaction of the intervention by both children and parents will be collected on a Likert scale of 1-10 representing ‘not easy/helpful/satisfied at all’ to ‘extremely easy/helpful/satisfied’

指标类型：

附加指标

Outcome：

Perceived levels of easiness, usefulness and satisfaction of the intervention by both children and parents will be collected on a Likert scale of 1-10 representing ‘not easy/helpful/satisfied at all’ to ‘extremely easy/helpful/satisfied’

Type：

Additional indicator

测量时间点：

post intervention

测量方法：

paper-based test

Measure time point of outcome：

post intervention

Measure method：

paper-based test

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 8 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

The randomisation will be conducted by an experienced independent statistician in an 1:1 ratio with computer-generated random numbers.

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomisation will be conducted by an experienced independent statistician in an 1:1 ratio with computer-generated random numbers.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

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

Blinding：

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

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Available upon request after trial completion

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Available upon request after trial completion

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Part of data will be collected through computerised program (e.g. ANT), or assessed by trained research personnel (e.g. TEA-Ch). Other data will be filled in paper. The data will be entered and saved in statistical software, Word and/or Excels files. The records will be locked in cabinets or saved in pass-word protected computers. Only the research team will have the access to all the data. Data will be reported aggregately and on personal identity will be revealed.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Part of data will be collected through computerised program (e.g. ANT), or assessed by trained research personnel (e.g. TEA-Ch). Other data will be filled in paper. The data will be entered and saved in statistical software, Word and/or Excels files. The records will be locked in cabinets or saved in pass-word protected computers. Only the research team will have the access to all the data. Data will be reported aggregately and on personal identity will be revealed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2018-02-01 19:41:05
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