Gamified Intervention to Enhance Resilience of Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

注册号:

Registration number:

ChiCTR2500108830 

最近更新日期:

Date of Last Refreshed on:

2025-09-08 08:29:31 

注册时间:

Date of Registration:

2025-09-08 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

Gamified Intervention to Enhance Resilience of Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

Public title:

Gamified Intervention to Enhance Resilience of Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Resilience of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): Development of a Conceptual Model and Intervention

Scientific title:

Resilience of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD): Development of a Conceptual Model and Intervention

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:

Yves Cho Ho Cheung 

研究负责人:

Yves Cho Ho Cheung 

Applicant:

Yves Cho Ho Cheung 

Study leader:

Yves Cho Ho Cheung 

申请注册联系人电话:

Applicant telephone:

+852 9766 6830

研究负责人电话:

Study leader's
telephone:

+852 9766 6830

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:

yvesresilience@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

yvesresilience@gmail.com

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:

Room AAB1035, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong Baptist University, Kowloon Tong, Hong Kong

研究负责人通讯地址:

Room AAB1035, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Applicant address:

Room AAB1035, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Study leader's address:

Room AAB1035, 10/F, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Hong Kong Baptist University, Kowloon Tong, 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:

Hong Kong Baptist University

Applicant's institution:

Hong Kong Baptist University

研究负责人所在单位:

Hong Kong Baptist University

Affiliation of the Leader:

Hong Kong Baptist 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:

FASS-SOWK-24-25-002

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:

Research Ethics Committee

Name of the ethic committee:

Research Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2025-07-22 00:00:00

伦理委员会联系人:

Catherine Li

Contact Name of the ethic committee:

Catherine Li

伦理委员会联系地址:

Research Ethics Committee, Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Contact Address of the ethic committee:

Research Ethics Committee, Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 3411 5577

伦理委员会联系人邮箱:

Contact email of the ethic committee:

licath@hkbu.edu.hk

研究实施负责(组长)单位:

Hong Kong Baptist University

Primary sponsor:

Hong Kong Baptist University

研究实施负责(组长)单位地址:

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Primary sponsor's address:

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

China

省(直辖市):

Hong Kong SAR

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

Hong Kong Baptist University

具体地址:

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Institution
hospital:

Hong Kong Baptist University

Address:

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

经费或物资来源:

None.

Source(s) of funding:

None.

研究疾病:

Attention-deficit Hyperactive Disorder (ADHD)  

Target disease:

Attention-deficit Hyperactive Disorder (ADHD)

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:

整群随机分组 

Study design:

Cluster randomization 

研究目的:

To evaluate the effectiveness of a tabletop role-playing game (TRPG) intervention on alleviating externalizing and internalizing difficulties of adolescents with Attention-deficit Hyperactive Disorder (ADHD).  

Objectives of Study:

To evaluate the effectiveness of a tabletop role-playing game (TRPG) intervention on alleviating externalizing and internalizing difficulties of adolescents with Attention-deficit Hyperactive Disorder (ADHD).

药物成份或治疗方案详述:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants. 

Description for medicine or protocol of treatment in detail:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants. 

纳入标准:

Inclusion criteria

排除标准:

Exclusion criteria include (a) severe mental illness or suicidal thoughts in the past 6 months.

Exclusion criteria:

Exclusion criteria include (a) severe mental illness or suicidal thoughts in the past 6 months.

研究实施时间:

Study execute time:

From 2025-09-05 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-09-08 00:00:00 To 2026-08-31 00:00:00

干预措施:

Interventions:

组别:

Intervention group

样本量:

50

Group:

Intervention group

Sample size:

干预措施:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants.

干预措施代码:

Intervention:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants.

Intervention code:

组别:

Waitlist control group

样本量:

50

Group:

Waitlist control group

Sample size:

干预措施:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants. It is identical to the intervention to be received by intervention group, but will occur after the intervention group has finished their intervention.

干预措施代码:

Intervention:

6 face-to-face, 1.5-hour sessions of a tabletop role-playing game designed for 6 participants. It is identical to the intervention to be received by intervention group, but will occur after the intervention group has finished their intervention.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

China

省(直辖市):

Hong Kong SAR 

市(区县):

 

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

China Holiness College 

单位级别:

Secondary School 

Institution
hospital:

China Holiness College

Level of the institution:

Secondary School

测量指标:

Outcomes:

指标中文名:

Internalizing and Externalizing Difficulties

指标类型:

主要指标

Outcome:

Internalizing and Externalizing Difficulties

Type:

Primary indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

ADHD Symptoms

指标类型:

主要指标

Outcome:

ADHD Symptoms

Type:

Primary indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

Parental Stress

指标类型:

次要指标

Outcome:

Parental Stress

Type:

Secondary indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

Quality of Life

指标类型:

次要指标

Outcome:

Quality of Life

Type:

Secondary indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

Resilience

指标类型:

附加指标

Outcome:

Resilience

Type:

Additional indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

Emotional Regulation

指标类型:

附加指标

Outcome:

Emotional Regulation

Type:

Additional indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

指标中文名:

Interpersonal competence

指标类型:

附加指标

Outcome:

Interpersonal competence

Type:

Additional indicator

测量时间点:

Pre-treatment, Post-treatment, 2-month follow-up

测量方法:

Questionnaire

Measure time point of outcome:

Pre-treatment, Post-treatment, 2-month follow-up

Measure method:

Questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

None

组织:

None

Sample Name:

None

Tissue:

None

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 10 years
最大 Max age 17 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):

Participants will be assigned to groups of six people. These groups will be randomized into either the treatment group or waitlist control group. Computerized block randomization will be used. Sequence generated by research assistants.

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

Participants will be assigned to groups of six people. These groups will be randomized into either the treatment group or waitlist control group. Computerized block randomization will be used. Sequence generated by research assistants.

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:

Participants and research assistants will be blinded to hypothesis.

Blinding:

Participants and research assistants will be blinded to hypothesis.

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):

not applicable

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

not applicable

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:

not applicable

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

not applicable

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-09-08 08:29:11