ChiCTR2500105284 版本V1.0 版本创建时间2025/07/01 16:01:12 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:

ChiCTR2500105284 

最近更新日期:

Date of Last Refreshed on:

2025-07-01 16:01:00 

注册时间:

Date of Registration:

2025-07-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

积极心理学视角下青少年心理健康促进的干预研究

Public title:

Intervention Research on Promoting Adolescent Mental Health from the Perspective of Positive Psychology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

积极心理学视角下青少年心理健康促进的干预研究

Scientific title:

Intervention Research on Promoting Adolescent Mental Health from the Perspective of Positive Psychology

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:

徐静 

研究负责人:

王晓琴 

Applicant:

Jing Xu 

Study leader:

Xiaoqin Wang 

申请注册联系人电话:

Applicant telephone:

+86 182 3978 2996

研究负责人电话:

Study leader's
telephone:

+86 159 0273 1922

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:

2024283070015@whu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

00008458@whu.edu.cn

申请单位网址(自愿提供):

Applicant website(voluntary supply):

武汉大学

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:

湖北省武汉市武昌区东湖路115号

研究负责人通讯地址:

湖北省武汉市武昌区东湖路115号

Applicant address:

No.115, Donghu Road, Wuchang District, Wuhan City, Hubei Province

Study leader's address:

No.115, Donghu Road, Wuchang District, Wuhan City, Hubei Province

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:

武汉大学

Applicant's institution:

Wuhan University

研究负责人所在单位:

武汉大学

Affiliation of the Leader:

Wuhan University

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:

WHU-LFMD-IRB2025050

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:

武汉大学生命医学伦理委员会

Name of the ethic committee:

Wuhan University Life Medical Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2025-05-30 00:00:00

伦理委员会联系人:

刘轲

Contact Name of the ethic committee:

Ke Liu

伦理委员会联系地址:

湖北省武汉市武昌区东湖路115号

Contact Address of the ethic committee:

No.115, Donghu Road, Wuchang District, Wuhan City, Hubei Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 68759329

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:

武汉大学

Primary sponsor:

Wuhan University

研究实施负责(组长)单位地址:

湖北省武汉市武昌区东湖路115号

Primary sponsor's address:

No.115, Donghu Road, Wuchang District, Wuhan City, Hubei Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北省

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学

具体地址:

湖北省武汉市武昌区东湖路115号

Institution
hospital:

Wuhan University

Address:

No.115, Donghu Road, Wuchang District, Wuhan City, Hubei Province

经费或物资来源:

Source(s) of funding:

None

研究疾病:

无  

Target disease:

None

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:

单臂 

Study design:

Single arm 

研究目的:

(1)了解青少年心理健康现状及其影响因素。 (2)基于积极心理学视角,构建促进青少年心理健康的干预方案。 (3)验证促进青少年心理健康干预方案的有效性和可行性。  

Objectives of Study:

1. Understand the current status of mental health among teenagers and its influencing factors. 2. Based on the perspective of positive psychology, construct an intervention plan to promote the mental health of teenagers. 3. Verify the effectiveness and feasibility of the intervention plan for promoting the mental health of teenagers.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

青少年纳入标准:①初中阶段学生,年龄在11~16岁。②自愿参加干预活动,父母或监护人同意并签署知情同意书。③具有基本的阅读和理解能力,能独立完成问卷。④居住地相对稳定,干预期间不计划长期离开本地。 青少年父母纳入标准:①为青少年的主要监护人,父亲/母亲均可。②有能力阅读、理解并完成问卷和参与活动。③同意配合项目管理安排和干预计划。

Inclusion criteria

Adolescent Inclusion Criteria: 1.Junior high school students aged 11 to 16. 2.Willing to participate in the intervention, with parents or guardians providing consent and signing the informed consent form. 3.Able to read and understand basic information to complete questionnaires independently. 4.Have a relatively stable residence and no plans to leave the local area for an extended period during the intervention. Parental Inclusion Criteria for Adolescents: 1.Primary caregivers of the adolescents (either father or mother). 2.Able to read, understand, complete questionnaires, and participate in activities. 3.Willing to comply with project management arrangements and the intervention plan.

排除标准:

青少年排除标准:①经诊断患有重度精神障碍(如重度抑郁、精神分裂症等)。②存在智力障碍或严重语言沟通障碍。③存在严重行为攻击、破坏倾向,或明显影响团体安全和秩序的行为。④正在接受其他心理治疗或参与类似干预项目。 青少年父母排除标准:①存在严重心理障碍,影响干预执行。②因身体或其他原因无法参与大部分干预与评估环节。③家庭近期有严重冲突事件(如家暴、法律纠纷等)。

Exclusion criteria:

Adolescent Exclusion Criteria: 1.Diagnosed with severe mental disorders (e.g., severe depression, schizophrenia). 2.Have intellectual disabilities or severe language communication disorders. 3.Exhibit highly aggressive, destructive behaviors, or actions that significantly affect group safety and order. 4.Currently undergoing other psychotherapies or participating in similar intervention programs. Parental Exclusion Criteria for Adolescents: 1.Have severe psychological disorders that would impact the implementation of the intervention. 2.Are unable to participate in most intervention and evaluation activities due to physical or other reasons. 3.Have experienced serious family conflicts (e.g., domestic violence, legal disputes) recently.

研究实施时间:

Study execute time:

From 2025-07-01 00:00:00 To 2026-07-10 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-07-14 00:00:00 To 2026-07-09 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

40

Group:

Intervention group

Sample size:

干预措施:

亲子共同参与的积极心理学团体辅导活动

干预措施代码:

Intervention:

Positive psychology group counseling activities jointly participated by parents and adolescent.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖北 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉市多所中学(根据学校要求对学校名称进行保密) 

单位级别:

中学 

Institution
hospital:

Several secondary schools (per institutional requirements, the school's identity remains confidential)

Level of the institution:

Secondary school

测量指标:

Outcomes:

指标中文名:

心理韧性

指标类型:

主要指标

Outcome:

Mental resilience

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

亲子沟通质量

指标类型:

主要指标

Outcome:

Parent-Adolescent Communication Quality

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理健康状况

指标类型:

次要指标

Outcome:

Mental health status

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:

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 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):

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

None

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:

Blinding:

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

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):

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:

EDC

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

EDC

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:

 2025-07-01 16:01:00