ChiCTR2100042344 版本V1.1 版本创建时间2021/04/18 23:00:11 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100042344 

最近更新日期：

Date of Last Refreshed on：

 2021-02-02 02:56:06 

注册时间：

Date of Registration：

 2021-01-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of School-based Mindfulness Intervention with Migrant Children in China: Building Resilience in an Under-served Population

Public title：

Effectiveness of School-based Mindfulness Intervention with Migrant Children in China: Building Resilience in an Under-served Population

注册题目简写：

English Acronym：

研究课题的正式科学名称：

School-based Mindfulness Intervention with Migrant Children in China

Scientific title：

School-based Mindfulness Intervention with Migrant Children in China

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：

Shuang Lu 

研究负责人：

Shuang Lu 

Applicant：

Shuang Lu 

Study leader：

Shuang Lu 

申请注册联系人电话：

Applicant telephone：

 +852 39172080

研究负责人电话：

Study leader's
telephone：

+852 39172080

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：

 shuanglu@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 shuanglu@hku.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：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

研究负责人通讯地址：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

Applicant address：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

Study leader's address：

Jockey Club Tower, 5/F, Pokfulam Rd, Hong Kong, China

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：

香港大學

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

香港大學

Affiliation of the Leader：

The 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：

 EA1802014

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：

香港大學人類研究倫理委員會

Name of the ethic committee：

The University of Hong Kong Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-02-28 00:00:00

伦理委员会联系人：

Becky Wong

Contact Name of the ethic committee：

Becky Wong

伦理委员会联系地址：

9th Floor, Knowles Building, The University of Hong Kong, Pokfulam, Hong Kong, China

Contact Address of the ethic committee：

9th Floor, Knowles Building, The University of Hong Kong, Pokfulam, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 28598039

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Hong Kong University Grants Committee, Research Grants Council

Primary sponsor：

Hong Kong University Grants Committee, Research Grants Council

研究实施负责（组长）单位地址：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Early Career Scheme

Source(s) of funding：

Early Career Scheme

研究疾病：

Emotional and behavioral development  

Target disease：

Emotional and behavioral development

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To examine the effects of school-based mindfulness intervention on child resilience. 2. To examine the effects of resilience on child emotion and behavior. 3. To identify the mediating role of resilience between mindfulness and child emotion and behavior. 4. To provide service recommendations that improve the emotional and behavioral wellbeing of migrant children in China and beyond.  

Objectives of Study：

1. To examine the effects of school-based mindfulness intervention on child resilience. 2. To examine the effects of resilience on child emotion and behavior. 3. To identify the mediating role of resilience between mindfulness and child emotion and behavior. 4. To provide service recommendations that improve the emotional and behavioral wellbeing of migrant children in China and beyond.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) 4th-6th graders from migrant schools in Shenzhen;
2) who give informed consent and parental consent;
3) who score 65-70 on the RCADS scale (indicating borderline risk of depressive and anxiety symptoms).

Inclusion criteria

1) 4th-6th graders from migrant schools in Shenzhen;
2) who give informed consent and parental consent;
3) who score 65-70 on the RCADS scale (indicating borderline risk of depressive and anxiety symptoms).

排除标准：

Given that this study targets general at-risk population, we will exclude students who have clinical diagnosis of severe mental illness (e.g. psychosis) or special education needs (e.g. ADHD, Autism Spectrum Disorder, learning disabilities) will be excluded.

Exclusion criteria：

Given that this study targets general at-risk population, we will exclude students who have clinical diagnosis of severe mental illness (e.g. psychosis) or special education needs (e.g. ADHD, Autism Spectrum Disorder, learning disabilities) will be excluded.

研究实施时间：

Study execute time：

从 From 2021-01-25 00:00:00至 To 2022-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-01-25 00:00:00 至 To 2021-02-15 00:00:00

干预措施：

Interventions：

组别：

Treatment group

样本量：

 150

Group：

Treatment group

Sample size：

干预措施：

Mindfulness training

干预措施代码：

Intervention：

Mindfulness training

Intervention code：

组别：

Control group

样本量：

 150

Group：

Control group

Sample size：

干预措施：

Psychoeducation

干预措施代码：

Intervention：

Psychoeducation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 廣東 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 schools 

单位级别：

 elementary school 

Institution
hospital：

schools

Level of the institution：

elementary school

测量指标：

Outcomes：

指标中文名：

Anxiety and depressive symptoms

指标类型：

主要指标

Outcome：

Anxiety and depressive symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Behavioral difficulties and strengths

指标类型：

主要指标

Outcome：

Behavioral difficulties and strengths

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Positive and negative affect

指标类型：

主要指标

Outcome：

Positive and negative affect

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sociocultural adaptation

指标类型：

次要指标

Outcome：

Sociocultural adaptation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Psychological resilience

指标类型：

次要指标

Outcome：

Psychological resilience

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Level of mindfulness

指标类型：

附加指标

Outcome：

Level of mindfulness

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 9 岁 years
最大 Max age 12 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）：

With a total sample size of 300, 60 eligible participants will be randomly selected from each school using a randomization web application (random.org) by a research assistant. Baseline data will then be collected. Participants will then be randomly assigned to an experimental group and a control group in a

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

With a total sample size of 300, 60 eligible participants will be randomly selected from each school using a randomization web application (random.org) by a research assistant. Baseline data will then be collected. Participants will then be randomly assigned to an experimental group and a control group in a

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

All intervention facilitators will provide a type of psychosocial development training (either mindfulness or psychoeducation) in separate groups and in a parallel format. The facilitators will not know to which treatment condition they are assigned.

Blinding：

All intervention facilitators will provide a type of psychosocial development training (either mindfulness or psychoeducation) in separate groups and in a parallel format. The facilitators will not know to which treatment condition they are assigned.

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）：

https://datahub.hku.hk/

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

https://datahub.hku.hk/

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：

Data will be collected in hardcopy. Indirect personal identifiers will be used to link participants to their responses. Direct identifiers will be removed after entering all assessments into Excel. Data will be kept for no more than 5 years after the study completes.

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

Data will be collected in hardcopy. Indirect personal identifiers will be used to link participants to their responses. Direct identifiers will be removed after entering all assessments into Excel. Data will be kept for no more than 5 years after the study completes.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-01-19 09:39:15