ChiCTR2500109010 版本V1.0 版本创建时间2025/09/10 11:27:13 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：

 ChiCTR2500109010 

最近更新日期：

Date of Last Refreshed on：

 2025-09-10 11:27:08 

注册时间：

Date of Registration：

 2025-09-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The efficacy of the Mindful Digital Buddies programme in strengthening digital resilience of young adolescents in Hong Kong: A pilot evaluation

Public title：

The efficacy of the Mindful Digital Buddies programme in strengthening digital resilience of young adolescents in Hong Kong: A pilot evaluation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The efficacy of the Mindful Digital Buddies programme in strengthening digital resilience of young adolescents in Hong Kong: A pilot evaluation

Scientific title：

The efficacy of the Mindful Digital Buddies programme in strengthening digital resilience of young adolescents in Hong Kong: A pilot evaluation

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：

Anson Chui Yan Tang  

研究负责人：

Anson Chui Yan Tang 

Applicant：

Anson Chui Yan Tang  

Study leader：

Anson Chui Yan Tang 

申请注册联系人电话：

Applicant telephone：

 +852 3468 6832

研究负责人电话：

Study leader's
telephone：

+852 3468 6832

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：

 ansontang@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ansontang@twc.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：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

研究负责人通讯地址：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

Applicant address：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

Study leader's address：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, 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：

School of Nursing, Tung Wah College

Applicant's institution：

School of Nursing, Tung Wah College

研究负责人所在单位：

School of Nursing, Tung Wah College

Affiliation of the Leader：

School of Nursing, Tung Wah College

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：

 REC2025255

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：

Research Ethics Committee, Tung Wah College

Name of the ethic committee：

Research Ethics Committee, Tung Wah College

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-06 00:00:00

伦理委员会联系人：

The Secretariat, Research Ethics Committee

Contact Name of the ethic committee：

The Secretariat, Research Ethics Committee

伦理委员会联系地址：

18/F, Research Office, Tung Wah College, Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin, Hong Kong

Contact Address of the ethic committee：

18/F, Research Office, Tung Wah College, Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3190 6768

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：

School of Nursing, Tung Wah College

Primary sponsor：

School of Nursing, Tung Wah College

研究实施负责（组长）单位地址：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

Primary sponsor's address：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, 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)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

School of Nursing, Tung Wah College

具体地址：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

Institution
hospital：

School of Nursing, Tung Wah College

Address：

16/F, Tower 2,Kowloon Commerce Centre,51 Kwai Cheong Road,Kwai Chung, Hong Kong

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Online behaviors  

Target disease：

Online behaviors

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

The overarching aim of the study is to strengthen the digital resilience of young adolescents in Hong Kong. There are two objectives in this pilot: 1) to estimate the preliminary effect and the effect size of the Mindful Digital Buddies programme on the primary outcome – resilience; and 2) to examine the feasibility of the intervention protocol  

Objectives of Study：

The overarching aim of the study is to strengthen the digital resilience of young adolescents in Hong Kong. There are two objectives in this pilot: 1) to estimate the preliminary effect and the effect size of the Mindful Digital Buddies programme on the primary outcome – resilience; and 2) to examine the feasibility of the intervention protocol

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Students aged 11-15 who regularly use the Internet will be recruited for the study

Inclusion criteria

Students aged 11-15 who regularly use the Internet will be recruited for the study

排除标准：

Those identified as having special education needs (SEN) will be excluded, as they may face challenges in following the trainer's instructions during the intervention.

Exclusion criteria：

Those identified as having special education needs (SEN) will be excluded, as they may face challenges in following the trainer's instructions during the intervention.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-15 00:00:00 至 To 2025-10-13 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 30

Group：

Intervention group

Sample size：

干预措施：

Adolescent participants will attend an 8-session mindful-art digital resilience workshop, with sessions held weekly for 1.5 hours each. Each group, consisting of 10-12 participants, will be guided by one mindfulness-art therapist in face-to-face sessions conducted in a primary school classroom. Table 1 outlines the objectives and activities for each session, which consist of two core components related to Internet use: discussion and mindful-art practice.

干预措施代码：

Intervention：

Adolescent participants will attend an 8-session mindful-art digital resilience workshop, with sessions held weekly for 1.5 hours each. Each group, consisting of 10-12 participants, will be guided by one mindfulness-art therapist in face-to-face sessions conducted in a primary school classroom. Table 1 outlines the objectives and activities for each session, which consist of two core components related to Internet use: discussion and mindful-art practice.

Intervention code：

组别：

Control group

样本量：

 30

Group：

Control group

Sample size：

干预措施：

The adolescent participants will receive a one-hour educational talk about Internet risks and managing stress and emotions related to Internet use. The talk will be delivered by a mental health nurse from the Department of Health. Meanwhile, their parents in the control group will be given a pamphlet that provides guidance on how to manage their children's Internet use effectively.

干预措施代码：

Intervention：

The adolescent participants will receive a one-hour educational talk about Internet risks and managing stress and emotions related to Internet use. The talk will be delivered by a mental health nurse from the Department of Health. Meanwhile, their parents in the control group will be given a pamphlet that provides guidance on how to manage their children's Internet use effectively.

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)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 School of Nursing, Tung Wah College 

单位级别：

 N/A 

Institution
hospital：

School of Nursing, Tung Wah College

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Digital resilience

指标类型：

主要指标

Outcome：

Digital resilience

Type：

Primary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

指标中文名：

Knowledge about online risks

指标类型：

次要指标

Outcome：

Knowledge about online risks

Type：

Secondary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

指标中文名：

Emotion regulation

指标类型：

次要指标

Outcome：

Emotion regulation

Type：

Secondary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

指标中文名：

Parental internet monitoring

指标类型：

次要指标

Outcome：

Parental internet monitoring

Type：

Secondary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

指标中文名：

Parent-child relationship

指标类型：

次要指标

Outcome：

Parent-child relationship

Type：

Secondary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

指标中文名：

Internet behaviors

指标类型：

次要指标

Outcome：

Internet behaviors

Type：

Secondary indicator

测量时间点：

Pre and post-intervention

测量方法：

Measure time point of outcome：

Pre and post-intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 11 岁 years
最大 Max age 15 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 unit of randomization is the primary school. These schools will be randomly assigned to either the intervention group or the control group by drawing lots.

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

The unit of randomization is the primary school. These schools will be randomly assigned to either the intervention group or the control group by drawing lots.

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：

None

Blinding：

None

是否共享原始数据：

IPD sharing

否No

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）：

None

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

None

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：

Only project team members will have access to the raw data. All self-administered questionnaires will be completed online using Google Forms. Digital copies of the data will be stored in the cloud with security measures in place. Personal identifiers will be removed after the study's completion. Digital copies will be permanently deleted from the cloud, and any hard copies will be shredded for seven years post-study.

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

Only project team members will have access to the raw data. All self-administered questionnaires will be completed online using Google Forms. Digital copies of the data will be stored in the cloud with security measures in place. Personal identifiers will be removed after the study's completion. Digital copies will be permanently deleted from the cloud, and any hard copies will be shredded for seven years post-study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-09-10 11:27:08