跨性別人士的心理健康: 有關介入方式的研究

注册号:

Registration number:

ChiCTR1900021042 

最近更新日期:

Date of Last Refreshed on:

2019-01-26 12:16:51 

注册时间:

Date of Registration:

2018-12-18 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

跨性別人士的心理健康: 有關介入方式的研究

Public title:

Psychological Adjustment of Transgender Individuals in Hong Kong: An Intervention Study

注册题目简写:

English Acronym:

Psychological Intervention for HK Transgender Individuals

研究课题的正式科学名称:

跨性別人士的心理健康: 有關介入方式的研究

Scientific title:

Psychological Adjustment of Transgender Individuals in Hong Kong: An Intervention 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:

CUHK_CCRB00646

申请注册联系人:

Sin Ling Yum Natalie 

研究负责人:

Ling Yum Natalie Sin 

Applicant:

Sin Ling Yum Natalie 

Study leader:

Ling Yum Natalie Sin 

申请注册联系人电话:

Applicant telephone:

+852 35052505

研究负责人电话:

Study leader's
telephone:

+852 64702361

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:

sly252@ha.org.hk

研究负责人电子邮件:

Study leader's E-mail:

natalie.sin@gmail.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/642

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/642

申请注册联系人通讯地址:

Department of Psychology, Prince of Wales Hospital, Hospital Authority

研究负责人通讯地址:

Department of Psychology, Prince of Wales Hospital, Hospital Authority

Applicant address:

Department of Psychology, Prince of Wales Hospital, Hospital Authority

Study leader's address:

Department of Psychology, Prince of Wales Hospital, Hospital Authority

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:

香港中文大學威爾斯親王醫院心理學系

Applicant's institution:

Department of Clinical Psychology, Prince of Wales Hospital

研究负责人所在单位:

香港中文大學威爾斯親王醫院心理學系

Affiliation of the Leader:

Department of Clinical Psychology, Prince of Wales Hospital

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:

2018.488-T

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:

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-07 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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心理學系

Primary sponsor:

Department of Clinical Psychology, Prince of Wales Hospital

研究实施负责(组长)单位地址:

Department of Clinical Psychology, Prince of Wales Hospital

Primary sponsor's address:

Department of Clinical Psychology, Prince of Wales Hospital

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Nil

Source(s) of funding:

Nil

研究疾病:

跨性別人士的心理健康  

Target disease:

Psychological Adjustment of Transgender Individuals

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

卫生服务研究 

Study phase:

Health Services Research

研究设计:

单臂 

Study design:

Single arm 

研究目的:

To investigate the benefits of intervention involving family members of transgender individuals in Hong Kong.  

Objectives of Study:

To investigate the benefits of intervention involving family members of transgender individuals in Hong Kong.

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:

Significant intellectual and/or communication deficits

Exclusion criteria:

Significant intellectual and/or communication deficits

研究实施时间:

Study execute time:

From 1990-01-01 00:00:00 To 1990-01-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2019-01-01 00:00:00 To 1990-01-01 00:00:00

干预措施:

Interventions:

组别:

50 patients [+50 of their relevant family member(s)]

样本量:

100

Group:

50 patients [+50 of their relevant family member(s)]

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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:

大学 

Institution
hospital:

Prince of Wales Hospital

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

Psychological Adjustment (transgender patients only)

指标类型:

主要指标

Outcome:

Psychological Adjustment (transgender patients only)

Type:

Primary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnnaire (Depression, Anxiety, and Stress Scale)

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnnaire (Depression, Anxiety, and Stress Scale)

指标中文名:

Communication Skills (Both family & transgender patients)

指标类型:

主要指标

Outcome:

Communication Skills (Both family & transgender patients)

Type:

Primary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnaire (Coping Strategies in Chinese Social Context Scale)

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnaire (Coping Strategies in Chinese Social Context Scale)

指标中文名:

Transphobic attitude (Family of transgender patients only)

指标类型:

主要指标

Outcome:

Transphobic attitude (Family of transgender patients only)

Type:

Primary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnaire (Genderism and Transphobia Scale)

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnaire (Genderism and Transphobia Scale)

指标中文名:

Perceived Family Support (transgender patient only)

指标类型:

主要指标

Outcome:

Perceived Family Support (transgender patient only)

Type:

Primary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnnaire (Multi-dimensional Scale of Perceived Social Support )

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnnaire (Multi-dimensional Scale of Perceived Social Support )

指标中文名:

Psychological Adjustment (transgender patients only)

指标类型:

次要指标

Outcome:

Psychological Adjustment (transgender patients only)

Type:

Secondary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnaire (Transgender Congruence Scale)

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnaire (Transgender Congruence Scale)

指标中文名:

Psychological Adjustment (transgender patients only)

指标类型:

次要指标

Outcome:

Psychological Adjustment (transgender patients only)

Type:

Secondary indicator

测量时间点:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

测量方法:

Questionnaire (Gender Congruence and Life Satisfaction Scale)

Measure time point of outcome:

2 weeks before the intervention, 2 weeks after the intervention, and 1 month after the intervention

Measure method:

Questionnaire (Gender Congruence and Life Satisfaction Scale)

采集人体标本:

Collecting sample(s)
from participants:

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 18 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

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):

未说明

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

Not stated

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:

未说明

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-26 12:16:51