ChiCTR2600119993 版本V1.0 版本创建时间2026/03/06 17:20:03 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:

ChiCTR2600119993 

最近更新日期:

Date of Last Refreshed on:

2026-03-06 17:19:59 

注册时间:

Date of Registration:

2026-03-06 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

构建韧性未来:通过两项社会情感学习创新项目促进农村青少年的积极成长

Public title:

Building Resilient Futures: Fostering Rural Adolescents’ Positive Development Through Two Innovative School-Based Social-Emotional Learning Programs

注册题目简写:

English Acronym:

研究课题的正式科学名称:

构建韧性未来:通过两项社会情感学习创新项目促进农村青少年的积极成长

Scientific title:

Building Resilient Futures: Fostering Rural Adolescents’ Positive Development Through Two Innovative School-Based Social-Emotional Learning Programs

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:

胡蕙 

研究负责人:

李姝兗 

Applicant:

Hui Hu 

Study leader:

Juyeon Lee 

申请注册联系人电话:

Applicant telephone:

+852 6672 4370

研究负责人电话:

Study leader's
telephone:

+852 3917 4374

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:

emmahui@connect.hku.hk

研究负责人电子邮件:

Study leader's E-mail:

leejy@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:

香港大学百周年校园赛马会教学楼

研究负责人通讯地址:

香港大学百周年校园赛马会教学楼, CJT-519

Applicant address:

Jockey Club Tower, Centennial Campus, HKU, Hong Kong, China

Study leader's address:

CJT-519, Jockey Club Tower, Centennial Campus, HKU, 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:

香港大学

Applicant's institution:

The University of Hong Kong

研究负责人所在单位:

香港大学

Affiliation of the Leader:

The University of Hong Kong

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

EA240441

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:

香港大学研究操守委员会

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:

2024-09-24 00:00:00

伦理委员会联系人:

Professor Z.M. Shen

Contact Name of the ethic committee:

Professor Z.M. Shen

伦理委员会联系地址:

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

Contact Address of the ethic committee:

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 3917 5267

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:

香港大学知识交流办公室

Primary sponsor:

HKU Knowledge Exchange Office

研究实施负责(组长)单位地址:

香港薄扶林香港大学本部大楼254室

Primary sponsor's address:

Room 254, Main Building, The University of Hong Kong, Pokfulam, Hong Kong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

香港

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

香港大学

具体地址:

薄扶林道赛马会大楼 5 楼

Institution
hospital:

The University of Hong Kong

Address:

Jockey Club Tower, 5/F, Pokfulam Rd

经费或物资来源:

2024/25 年度知识交流影响项目资助计划

Source(s) of funding:

KE Funding Scheme for Impact Projects 2024/25

研究疾病:

儿童心理健康  

Target disease:

Children's psychosocial 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:

整群随机抽样 

Study design:

Cluster randomly sampling 

研究目的:

To examine the effectiveness of two innovative school-based social-emotional learning programs in improving adolescents’ social-emotional skills, reducing internalizing and externalizing behaviors, and preventing problematic digital use.  

Objectives of Study:

To examine the effectiveness of two innovative school-based social-emotional learning programs in improving adolescents’ social-emotional skills, reducing internalizing and externalizing behaviors, and preventing problematic digital use.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Middle school students will be recruited. As this is a school-based SEL program aimed to improve the well-being and mental health of students, the program is considered to not adversely affect participants’ rights or welfare. Therefore, we will include all the students in the classes in which the teacher in charge consents to participate. Students and their parents/guardians will be invited to give their informed assent/consent to take part in the study. In light of the classroom setting, students could not avoid participating in this program; however, they have the right to decide whether their data will be collected for this study or not. Students who do not provide assent or parental consent to participate in data collection will be encouraged to participate actively in the program, while their data will not be collected.

Inclusion criteria

Middle school students will be recruited. As this is a school-based SEL program aimed to improve the well-being and mental health of students, the program is considered to not adversely affect participants’ rights or welfare. Therefore, we will include all the students in the classes in which the teacher in charge consents to participate. Students and their parents/guardians will be invited to give their informed assent/consent to take part in the study. In light of the classroom setting, students could not avoid participating in this program; however, they have the right to decide whether their data will be collected for this study or not. Students who do not provide assent or parental consent to participate in data collection will be encouraged to participate actively in the program, while their data will not be collected.

排除标准:

Students who are unable to attend school during the intervention period.

Exclusion criteria:

Students who are unable to attend school during the intervention period.

研究实施时间:

Study execute time:

From 2024-09-24 00:00:00 To 2028-09-23 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-10-18 00:00:00 To 2025-06-01 00:00:00

干预措施:

Interventions:

组别:

干预组1

样本量:

400

Group:

Intervention group 1

Sample size:

干预措施:

Standard social-emotional learning intervention

干预措施代码:

Intervention:

Standard social-emotional learning intervention

Intervention code:

组别:

干预组2

样本量:

400

Group:

Intervention group 2

Sample size:

干预措施:

Enhanced social-emotional learning intervention including standard SEL program and additional SEL program specifically targeting digital addiction.

干预措施代码:

Intervention:

Enhanced social-emotional learning intervention including standard SEL program and additional SEL program specifically targeting digital addiction.

Intervention code:

组别:

对照组

样本量:

400

Group:

Practice as usual group

Sample size:

干预措施:

Practice as usual

干预措施代码:

Intervention:

Practice as usual

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆市 

市(区县):

云阳县 

Country:

China

Province:

Chongqing

City:

Yunyang

单位(医院):

30间中学 

单位级别:

N/A 

Institution
hospital:

30 middile schools

Level of the institution:

N/A

测量指标:

Outcomes:

指标中文名:

社会情感能力

指标类型:

主要指标

Outcome:

Social-emotional competencies

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

数字健康

指标类型:

主要指标

Outcome:

Digital flourishing

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学生心理及行为健康

指标类型:

主要指标

Outcome:

Mental and behavioral health

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

欺凌行为

指标类型:

次要指标

Outcome:

Bullying involvement

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学业成果

指标类型:

次要指标

Outcome:

Academic learning outcomes

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会人口统计信息

指标类型:

次要指标

Outcome:

Socio-demographic information

Type:

Secondary 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:

标本中文名:

组织:

Sample Name:

N/A

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 9 years
最大 Max age 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 project impact will be assessed using a three-arm cluster randomized design. 7th graders from rural areas who meet the eligibility criteria were randomly allocated to one of three groups: 1) a wait-list control group; 2) a group receiving a standard social-emotional learning (SEL) program consisting of nine sessions; and 3) a group receiving both the standard nine-session SEL program and an additional eight-session SEL program specifically targeting digital addiction. To minimize the risk of cross-arm contamination, randomization will be conducted at the school level, ensuring that all eligible participants from the same school are assigned to the same condition.

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

The project impact will be assessed using a three-arm cluster randomized design. 7th graders from rural areas who meet the eligibility criteria were randomly allocated to one of three groups: 1) a wait-list control group; 2) a group receiving a standard social-emotional learning (SEL) program consisting of nine sessions; and 3) a group receiving both the standard nine-session SEL program and an additional eight-session SEL program specifically targeting digital addiction. To minimize the risk of cross-arm contamination, randomization will be conducted at the school level, ensuring that all eligible participants from the same school are assigned to the same condition.

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:

Outcome assessors (research assistants and/or social workers) will be blinded from treatment allocation.

Blinding:

Outcome assessors (research assistants and/or social workers) will be blinded from treatment allocation.

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/ ;国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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

https://datahub.hku.hk/ ; China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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:

Indirect personal identifiers (a numeric code assigned to each participant) will be used to link participants to their responses. The anonymized data will be kept for 5 years after publication of research results.

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

Indirect personal identifiers (a numeric code assigned to each participant) will be used to link participants to their responses. The anonymized data will be kept for 5 years after publication of research results.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-03-06 17:19:59