ChiCTR2500101266 版本V1.0 版本创建时间2025/04/22 18:40:01 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：

 ChiCTR2500101266 

最近更新日期：

Date of Last Refreshed on：

 2025-04-22 18:39:42 

注册时间：

Date of Registration：

 2025-04-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

A Quasi-experimental Study on a Co-production and School-based Psychosocial Well-being Program in Hong Kong

Public title：

A Quasi-experimental Study on a Co-production and School-based Psychosocial Well-being Program in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Healing Together – Building Positive School Mental Health in Post-COVID Hong Kong

Scientific title：

Healing Together – Building Positive School Mental Health in Post-COVID Hong Kong

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：

Wei Shijuan 

研究负责人：

Angel Hor Yan LAI 

Applicant：

Wei Shijuan 

Study leader：

Angel Hor Yan LAI 

申请注册联系人电话：

Applicant telephone：

 +852 8493 5456

研究负责人电话：

Study leader's
telephone：

+852 9089 1346

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：

 2278406855@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 angelhy.lai@polyu.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：

Room D, Rear Block, 13/F, 408A-B Des Voeux Road West, Hong Kong Island

研究负责人通讯地址：

The Hong Kong Polytechnic University, Hong Kong

Applicant address：

Room D, Rear Block, 13/F, 408A-B Des Voeux Road West, Hong Kong Island

Study leader's address：

The Hong Kong Polytechnic University, 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：

Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong

Applicant's institution：

Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong

研究负责人所在单位：

Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong

Affiliation of the Leader：

Department of Applied Social Sciences, The Hong Kong Polytechnic University, 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：

 HSEARS20230111001

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 Hong Kong Polytechnic University Institutional Review Board

Name of the ethic committee：

The Hong Kong Polytechnic University Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-01-16 00:00:00

伦理委员会联系人：

Li Chi Mei Jessica

Contact Name of the ethic committee：

Li Chi Mei Jessica

伦理委员会联系地址：

GH346, The Hong Kong Polytechnic University

Contact Address of the ethic committee：

GH346, The Hong Kong Polytechnic University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3400 3021

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 cmj.li@polyu.edu.hk

研究实施负责（组长）单位：

Hong Kong Polytechnic University

Primary sponsor：

Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

The Hong Kong Polytechnic University, Hong Kong

Primary sponsor's address：

The Hong Kong Polytechnic University, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Hong Kong

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

Health Bureau

具体地址：

19/F, East Wing, Central Government Offices, 2 Tim Mei Avenue, Tamar, Hong Kong

Institution
hospital：

Health Bureau

Address：

19/F, East Wing, Central Government Offices, 2 Tim Mei Avenue, Tamar, Hong Kong

经费或物资来源：

Mental Health Initiatives Funding Scheme

Source(s) of funding：

Mental Health Initiatives Funding Scheme

研究疾病：

mental well-being  

Target disease：

mental well-being

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：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

Improved self-compassion levels among students, reduced stigma of mental illness, enhanced social support from teachers and peers in the school environment, and increased sense of school belonging.  

Objectives of Study：

Improved self-compassion levels among students, reduced stigma of mental illness, enhanced social support from teachers and peers in the school environment, and increased sense of school belonging.

药物成份或治疗方案详述：

The "Co-creating Healing Schools" project adopts a strengths-based approach, allowing secondary school students at risk of mental health issues to co-create a space in their school, fostering positive mental health among their peers, teachers, and school administrators. Unlike existing programs that often view students as service users and "problems to be solved," our participants will receive professional assistance to co-design a space in their school to promote positive mental health. The proposed plan is not just about holding a series of workshops but focuses on changing the school environment and utilizing school resources to build positive mental health for all key stakeholders in the school. According to ecosystem theory, improving the external environment is the first step in promoting positive mental health. The proposed plan also adopts a "train-the-trainer" approach, focusing on nurturing existing student participants to become peer leaders and lead subsequent design thinking workshops. This ensures the sustainability of the project and enables students to self-manage their mental health. 

Description for medicine or protocol of treatment in detail：

The "Co-creating Healing Schools" project adopts a strengths-based approach, allowing secondary school students at risk of mental health issues to co-create a space in their school, fostering positive mental health among their peers, teachers, and school administrators. Unlike existing programs that often view students as service users and "problems to be solved," our participants will receive professional assistance to co-design a space in their school to promote positive mental health. The proposed plan is not just about holding a series of workshops but focuses on changing the school environment and utilizing school resources to build positive mental health for all key stakeholders in the school. According to ecosystem theory, improving the external environment is the first step in promoting positive mental health. The proposed plan also adopts a "train-the-trainer" approach, focusing on nurturing existing student participants to become peer leaders and lead subsequent design thinking workshops. This ensures the sustainability of the project and enables students to self-manage their mental health. 

纳入标准：

1. Students attend one of the 8 participating schools in Hong Kong. 2. Students who are in secondary 2 to secondary 4. 3. Students who provide a signed consent form.

Inclusion criteria

1. Students attend one of the 8 participating schools in Hong Kong. 2. Students who are in secondary 2 to secondary 4. 3. Students who provide a signed consent form.

排除标准：

1.Students who do not provide informed consent

Exclusion criteria：

1.Students who do not provide informed consent

研究实施时间：

Study execute time：

从 From 2023-03-15 00:00:00至 To 2024-09-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-18 00:00:00 至 To 2024-01-15 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 2000

Group：

Experimental group

Sample size：

干预措施：

We embraced the co-production approach throughout the program conceptualization, design and delivery. During the initial program conceptualization stage, we collaborated with a local non-profit organization, which was known for its extensive knowledge in frontline youth practices, to co-design the framework of Healing Space. At the program design stage, we engaged school management and teachers to discuss each session, ensuring Healing Space met the specific needs of individual schools and their students. Students were actively involved at the program delivery stage. Student participants were categorized into two groups based on their level of program engagement: (1) Students who directly participated in the co-production workshop (Co-producers) and (2) Students who did not directly participate in the program (Users only). Co-producers attended a total of six training workshops, which were co-delivered by registered social workers and the research team. The workshops started with a professional-led approach which slowly progressed into peer-led. The service-users group join the program as participants of the mental-health related interactive installations designed and delivered by their peer co-producers.

干预措施代码：

Intervention：

We embraced the co-production approach throughout the program conceptualization, design and delivery. During the initial program conceptualization stage, we collaborated with a local non-profit organization, which was known for its extensive knowledge in frontline youth practices, to co-design the framework of Healing Space. At the program design stage, we engaged school management and teachers to discuss each session, ensuring Healing Space met the specific needs of individual schools and their students. Students were actively involved at the program delivery stage. Student participants were categorized into two groups based on their level of program engagement: (1) Students who directly participated in the co-production workshop (Co-producers) and (2) Students who did not directly participate in the program (Users only). Co-producers attended a total of six training workshops, which were co-delivered by registered social workers and the research team. The workshops started with a professional-led approach which slowly progressed into peer-led. The service-users group join the program as participants of the mental-health related interactive installations designed and delivered by their peer co-producers.

Intervention code：

组别：

Control group

样本量：

 1000

Group：

Control group

Sample size：

干预措施：

There will be no intervention between the pre-test and post-test phases. Participants will receive the intervention until the experimental group has completed the intervention.

干预措施代码：

Intervention：

There will be no intervention between the pre-test and post-test phases. Participants will receive the intervention until the experimental group has completed the intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 The Hong Kong Polytechnic University 

单位级别：

 University 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Self-stigma related to mental illness.

指标类型：

主要指标

Outcome：

Self-stigma related to mental illness.

Type：

Primary indicator

测量时间点：

测量方法：

Paper survey

Measure time point of outcome：

Measure method：

Paper survey

指标中文名：

Self-compassion.

指标类型：

主要指标

Outcome：

Self-compassion.

Type：

Primary indicator

测量时间点：

测量方法：

Paper survey

Measure time point of outcome：

Measure method：

Paper survey

指标中文名：

Sense of School Belonging

指标类型：

次要指标

Outcome：

Sense of School Belonging

Type：

Secondary indicator

测量时间点：

测量方法：

Paper survey

Measure time point of outcome：

Measure method：

Paper survey

指标中文名：

Perceived Teacher support

指标类型：

次要指标

Outcome：

Perceived Teacher support

Type：

Secondary indicator

测量时间点：

测量方法：

Paper survey

Measure time point of outcome：

Measure method：

Paper survey

指标中文名：

Perceived Classmate Support

指标类型：

次要指标

Outcome：

Perceived Classmate Support

Type：

Secondary indicator

测量时间点：

测量方法：

Paper survey

Measure time point of outcome：

Measure method：

Paper survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 10 岁 years
最大 Max age 20 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）：

Our team will first work with our community partner to contact around 16 schools randomly using the drawing lots method from their school network. Then, 8 secondary schools in Hong Kong will be invited to participate in the program. Experimental schools and control schools will be assigned based on their schedule and availability.

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

Our team will first work with our community partner to contact around 16 schools randomly using the drawing lots method from their school network. Then, 8 secondary schools in Hong Kong will be invited to participate in the program. Experimental schools and control schools will be assigned based on their schedule and availability.

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：

Blinding：

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）：

Data is available on reasonable request from the corresponding author.

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

Data is available on reasonable request from the corresponding author.

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：

During the research, all the questionnaires will be processed anonymously, and the research team will give an identifier to each questionnaire for follow up purpose. The focus group interview will be audio taped. Participants may refuse to be audio taped at any time during the interview. Participants can listen to the recording upon the completion of the interview. All personal information and data collected in digital format and audio recordings will be stored in a shared drive of the The Hong Kong Polytechnic University which is encrypted. Only members of the research team will have access to the information. All members of the research team were required to sign a confidential agreement, meaning that they will not disclose any personal information of the participants to people out of the research team. All data including the hard and soft copies of questionnaires, voice recordings and transcripts will be destroyed within 6 months upon completion of the study.

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

During the research, all the questionnaires will be processed anonymously, and the research team will give an identifier to each questionnaire for follow up purpose. The focus group interview will be audio taped. Participants may refuse to be audio taped at any time during the interview. Participants can listen to the recording upon the completion of the interview. All personal information and data collected in digital format and audio recordings will be stored in a shared drive of the The Hong Kong Polytechnic University which is encrypted. Only members of the research team will have access to the information. All members of the research team were required to sign a confidential agreement, meaning that they will not disclose any personal information of the participants to people out of the research team. All data including the hard and soft copies of questionnaires, voice recordings and transcripts will be destroyed within 6 months upon completion of the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-04-22 18:39:42