Effects of the resilience-based Understanding Adolescent Project (UAP1.1) in mental health and resilience among Hong Kong secondary school students: Evaluation for a pilot study

注册号:

Registration number:

ChiCTR1800017795 

最近更新日期:

Date of Last Refreshed on:

2018-08-15 11:06:00 

注册时间:

Date of Registration:

2018-08-15 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

Effects of the resilience-based Understanding Adolescent Project (UAP1.1) in mental health and resilience among Hong Kong secondary school students: Evaluation for a pilot study

Public title:

Effects of the resilience-based Understanding Adolescent Project (UAP1.1) in mental health and resilience among Hong Kong secondary school students: Evaluation for a pilot study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Effects of the resilience-based Understanding Adolescent Project (UAP1.1) in mental health and resilience among Hong Kong secondary school students: Evaluation for a pilot study

Scientific title:

Effects of the resilience-based Understanding Adolescent Project (UAP1.1) in mental health and resilience among Hong Kong secondary school students: Evaluation for a pilot study

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:

Joseph Tak Fai Lau 

研究负责人:

Joseph Tak Fai Lau 

Applicant:

Joseph Tak Fai Lau 

Study leader:

Joseph Tak Fai Lau 

申请注册联系人电话:

Applicant telephone:

+852 26376606

研究负责人电话:

Study leader's
telephone:

+852 26376606

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:

jlau@cuhk.edu.hk

研究负责人电子邮件:

Study leader's E-mail:

jlau@cuhk.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:

中國香港特別行政區沙田威爾斯親王醫院公共衛生學院5樓

研究负责人通讯地址:

中國香港特別行政區沙田威爾斯親王醫院公共衛生學院5樓

Applicant address:

5/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address:

5/F, School of Public Health, Prince of Wales Hospital, Shatin, 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:

香港中文大學

Applicant's institution:

The Chinese University of Hong Kong

研究负责人所在单位:

香港中文大學

Affiliation of the Leader:

The Chinese 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:

151-17

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

香港中文大學調查與行為研究倫理委員會

Name of the ethic committee:

Survey and Behavioral Research Ethics Committee, The Chinese University of Hong Kong

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-04 00:00:00

伦理委员会联系人:

Alice Hung

Contact Name of the ethic committee:

Alice Hung

伦理委员会联系地址:

香港中文大學醫學院分委會

Contact Address of the ethic committee:

Sub-committee, Faculty of Medicine, The Chinese University of Hong Kong

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

香港中文大學威爾斯親王醫院

Primary sponsor:

School of Public Health, Prince of Wales Hospital, The Chinese University of Hong Kong

研究实施负责(组长)单位地址:

中國香港特別行政區沙田威爾斯親王醫院公共衛生學院5樓

Primary sponsor's address:

5/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

九龍樂善堂慈善會

Source(s) of funding:

The Lok Sin Tong Benevolent Society Kowloon

研究疾病:

精神衛生  

Target disease:

Mental health

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:

探索性研究/预试验 

Study phase:

0

研究设计:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

To enhance students' resilience and mental health through an integrated interventions including social connectedness, cognitive restructuring, problem solving, and emotional regulation.  

Objectives of Study:

To enhance students' resilience and mental health through an integrated interventions including social connectedness, cognitive restructuring, problem solving, and emotional regulation.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

N/A

Exclusion criteria:

N/A

研究实施时间:

Study execute time:

From 2017-05-31 00:00:00 To 2019-08-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2017-09-01 00:00:00 To 2017-11-30 00:00:00

干预措施:

Interventions:

组别:

Secondary school students

样本量:

611

Group:

Secondary school students

Sample size:

干预措施:

Resilience and mental distress

干预措施代码:

Intervention:

Resilience and mental distress

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

香港中文大學威爾斯親王醫院 

单位级别:

三级医院 

Institution
hospital:

The Chinese University of Hong Kong

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

Resilience and mental distress

指标类型:

主要指标

Outcome:

Resilience and mental distress

Type:

Primary 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:

No

组织:

Sample Name:

No

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 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):

N/A

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

N/A

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:

N/A

Blinding:

N/A

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

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):

ResMan临床试验公共管理平台

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

ResMan (www.medresman.org)

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:

Data were collected by self-administered questionnaire by the students and focus group interviews. The quantitative data were then entered into the computer by research workers. The data were anonymous and only the related research workers have access to them. For focus group interviews, they were all audiotaped and later transcribed by research workers. The transcripts were also anonymous.

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

Data were collected by self-administered questionnaire by the students and focus group interviews. The quantitative data were then entered into the computer by research workers. The data were anonymous and only the related research workers have access to them. For focus group interviews, they were all audiotaped and later transcribed by research workers. The transcripts were also anonymous.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2018-08-15 11:06:00