ChiCTR2500104079 版本V1.0 版本创建时间2025/06/10 17:33:00 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:

ChiCTR2500104079 

最近更新日期:

Date of Last Refreshed on:

2025-06-10 17:32:56 

注册时间:

Date of Registration:

2025-06-10 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

基于问题与发展视角下青少年心理危机促发和缓冲机制

Public title:

Initiation and buffering mechanism of adolescent psychological crisis from the perspective of problems and development

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于问题与发展视角下青少年心理危机促发和缓冲机制

Scientific title:

Initiation and buffering mechanism of adolescent psychological crisis from the perspective of problems and development

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:

牛荦菲 

研究负责人:

李欢欢 

Applicant:

Niu Luofei 

Study leader:

Li Huanhuan 

申请注册联系人电话:

Applicant telephone:

+86 155 4196 5889

研究负责人电话:

Study leader's telephone:

+86 134 3989 2584

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:

niuluofei567@ruc.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

psylihh@ruc.edu.cn

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:

北京市海淀区中关村大街59号

研究负责人通讯地址:

北京市海淀区中关村大街59号

Applicant address:

No. 59, Zhongguancun Street, Haidian District, Beijing

Study leader's address:

No. 59, Zhongguancun Street, Haidian District, Beijing

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:

中国人民大学

Applicant's institution:

Renmin University of China

研究负责人所在单位:

中国人民大学

Affiliation of the Leader:

Renmin University of China

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

22-052;24-068

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:

中国人民大学心理学系伦理委员会

Name of the ethic committee:

Ethics Committee of the Department of Psychology, Renmin University of China

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-28 00:00:00

伦理委员会联系人:

李永娜

Contact Name of the ethic committee:

Li Yongna

伦理委员会联系地址:

北京市海淀区中关村大街59号

Contact Address of the ethic committee:

No. 59, Zhongguancun Street, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 6251 3887

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lunlishenhe@163.com

研究实施负责(组长)单位:

中国人民大学

Primary sponsor:

Renmin University of China

研究实施负责(组长)单位地址:

北京市海淀区中关村大街59号

Primary sponsor's address:

No. 59, Zhongguancun Street, Haidian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民大学

具体地址:

北京市海淀区中关村大街59号

Institution
hospital:

Renmin University of China

Address:

No. 59, Zhongguancun Street, Haidian District, Beijing

经费或物资来源:

国家社科基金项目(24ASH015)

Source(s) of funding:

National Social Science Fund of China (24ASH015)

Target disease:

Social anxiety

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:

本研究旨在摆脱单一的“问题”导向视角,整合青少年的积极发展素质与发展资源,探索更为全面的青少年心理危机促发和缓冲因素,并基于前面的研究不断完善培养青少年积极发展素质网站,探索其对社交焦虑等心理问题的干预效果。注重文化环境在心理危机形成和发展的作用,重视对宏观因素的探索。综合采用量化与质性手段,从多维的研究视角,更全面地揭示青少年心理危机的复杂形式机制,并为综合干预与预防措施提供实证依据,为青少年心理健康促进及心理危机改善提供探索性指导。  

Objectives of Study:

This study aims to break away from the single "problem" oriented perspective, integrate the positive development qualities and development resources of teenagers, explore more comprehensive factors that trigger and buffer psychological crises in teenagers, and continuously improve the website for cultivating the positive development qualities of teenagers based on previous research, and explore its intervention effect on psychological problems such as social anxiety. Pay attention to the role of the cultural environment in the formation and development of psychological crises and attach importance to the exploration of macro factors. By comprehensively adopting quantitative and qualitative means and from a multi-dimensional research perspective, this paper more comprehensively reveals the complex formal mechanisms of adolescent psychological crises, provides empirical basis for comprehensive intervention and prevention measures, and offers exploratory guidance for the promotion of adolescent mental health and the improvement of psychological crises.

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、青少年社交焦虑量表(SAS-A)得分在前27%; 2、年龄在12-16岁之间的中国初中生; 3、有手机或电脑。

Inclusion criteria

1. Adolescent Social Anxiety Scale (SAS-A) score in the top 27%; 2. Chinese junior high school students between the ages of 12 and 16; 3. Have a mobile phone or computer.

排除标准:

1、最近三个月内曾服用精神药物; 2、在过去三个月内接受过心理治疗; 3、有自杀、自伤的风险; 4、参与动机低或不能参加所有项目。

Exclusion criteria:

1. Have taken psychotropic drugs in the past three months; 2. Received psychological treatment within the past three months; 3. There is a risk of suicide and self-harm; 4. Low motivation to participate or unable to participate in all projects.

研究实施时间:

Study execute time:

From 2022-02-21 00:00:00 To 2025-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-09-01 00:00:00 To 2025-10-31 00:00:00  

干预措施:

Interventions:

组别:

PYD互联网干预组

样本量:

50

Group:

Internet-based PYD (IPT) group

Sample size:

干预措施:

IPT项目侧重于提高自我价值和建立联结。通过自建干预网站进行。自我价值部分包括两个主题:探索优势和自我接纳。联结部分包括三个主题:社交积极思维、建立和维持关系、解决冲突和应对欺凌。该项目为期5周,每周完成一个主题。每个主题包含2-3个模块,每个模块需要15-25分钟完成。参与者可以选择一次完成一个模块,但需要在一周内完成每个主题。

干预措施代码:

Intervention:

The IPT program focused on increasing self-worth and making connection, and it was implemented via a self-built website. The self-worth part included two themes: exploring strengths and self-acceptance. The connection part included three themes: social positive thinking, establishing and maintaining relationships, conflict resolution and coping with bullying. The IPT program ran for 5 weeks, with one theme completed per week. Each theme contained 2–3 modules, and each module took 15–25 minutes to complete. The participants could choose to complete one module at a time but needed to complete each theme in one week.

Intervention code:

组别:

PYD团体辅导组

样本量:

50

Group:

group-based PYD (GPT) group

Sample size:

干预措施:

GPT项目侧重于提高自我价值和建立联结,通过团辅的方式进行。自我价值部分包括两个主题:探索优势和自我接纳。联结部分包括三个主题:社交积极思维、建立和维持关系、解决冲突和应对欺凌。该项目为期5周,每周完成一个主题,每次60分钟。

干预措施代码:

Intervention:

The GPT program focused on increasing self-worth and making connection, and it was implemented by group counseling. The self-worth part included two themes: exploring strengths and self-acceptance. The connection part included three themes: social positive thinking, establishing and maintaining relationships, conflict resolution and coping with bullying. The GPT program ran for 5 weeks, with one theme completed per week for 60 minutes at a time.

Intervention code:

组别:

心理教育常规治疗组

样本量:

50

Group:

Usual treatment with psychoeducation (TAU) group

Sample size:

干预措施:

TAU项目包括五次每周60分钟的会议。主题包括:心理健康、抑郁与焦虑、自杀预防、大脑和人格。

干预措施代码:

Intervention:

The TAU program consisted of five 60-minute weekly sessions. The following topics were covered: mental health, depression and anxiety, suicide prevention, brain, personality.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民大学 

单位级别:

大学 

Institution
hospital:

Renmin University of China

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

社交焦虑

指标类型:

主要指标

Outcome:

Social anxiety

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

青少年积极发展素质

指标类型:

主要指标

Outcome:

Positive Youth Development

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理危机

指标类型:

次要指标

Outcome:

Psychological crisis

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理痛苦

指标类型:

次要指标

Outcome:

Psychological Pain

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

校园压力事件

指标类型:

次要指标

Outcome:

Campus stress events

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

友谊质量

指标类型:

次要指标

Outcome:

Friendship Quality

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感知教师自主支持

指标类型:

次要指标

Outcome:

Perceive teachers' autonomous support

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

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 12 years
最大 Max age 16 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):

由研究小组主试用计算机产生随机数来进行随机化分配

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

Study group subjects used a computer to generate random numbers for randomization allocation.

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:

None

是否共享原始数据:

IPD sharing

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):

研究结束后,通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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:

 2025-06-10 17:32:56