ChiCTR2600118426 版本V1.0 版本创建时间2026/02/05 11:45:41 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：

ChiCTR2600118426 

最近更新日期：

Date of Last Refreshed on：

2026-02-05 11:45:35 

注册时间：

Date of Registration：

2026-02-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Efficacy of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents at risk of gaming disorder: A randomized controlled trial

Public title：

Efficacy of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents at risk of gaming disorder: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Efficacy of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents at risk of gaming disorder: A randomized controlled trial

Scientific title：

Efficacy of a mentalization-informed motivational interviewing group intervention for concerned significant others of adolescents at risk of gaming disorder: A randomized controlled trial

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：

Lo Kin Ming Camilla 

研究负责人：

Lo Kin Ming Camilla 

Applicant：

Lo Kin Ming Camilla 

Study leader：

Lo Kin Ming Camilla 

申请注册联系人电话：

Applicant telephone：

+852 2766 5760

研究负责人电话：

Study leader's telephone：

+852 2766 5760

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：

camilla.lo@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

camilla.lo@polyu.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：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

研究负责人通讯地址：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Applicant address：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Study leader's address：

11 Yuk Choi Road, Hung Hom, Kowloon, 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：

The Hong Kong Polytechnic University

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

The Hong Kong Polytechnic University

Affiliation of the Leader：

The Hong Kong Polytechnic University

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：

HSEARS20240221006; HSEARS20240221006-01

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：

The Hong Kong Polytechnic University Institutional Review Board

Name of the ethic committee：

The Hong Kong Polytechnic University Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-21 00:00:00

伦理委员会联系人：

Siu Yuen Man, Delegate

Contact Name of the ethic committee：

Siu Yuen Man, Delegate

伦理委员会联系地址：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Contact Address of the ethic committee：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 2766 6378

伦理委员会联系人邮箱：

Contact email of the ethic committee：

judy.ym.siu@polyu.edu.hk

研究实施负责（组长）单位：

The Hong Kong Polytechnic University

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Primary sponsor's address：

11 Yuk Choi Road, Hung Hom, Kowloon, 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

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Hong Kong Polytechnic University

具体地址：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

Institution
hospital：

The Hong Kong Polytechnic University

Address：

11 Yuk Choi Road, Hung Hom, Kowloon, Hong Kong

经费或物资来源：

The Hong Kong Polytechnic University

Source(s) of funding：

The Hong Kong Polytechnic University

Target disease：

Gaming disorder

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：

 

Objectives of Study：

1. To develop a brief, mentalization-informed motivational interviewing group intervention tailored for concerned significant others (CSOs) of adolescents at risk of gaming disorder (GD); 2. To determine whether the proposed intervention is efficient in reducing the primary outcomes (CSOs’ mental health symptoms) and secondary outcomes (CSO’s reflective capacity, CSO’s emotion regulation, CSO-adolescent conflicts and relationship satisfaction, and CSO-rated severity of GD of the adolescent); and 3. To determine whether the intervention efficacy will be maintained during a 6-month follow-up period.

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. Parents or other major caregivers (e.g., grandparents and legal guardians) of an adolescent child (10 to 19 years old) with/at risk of GD (defined as CSO-rated IGDS-SF9 score >=21); 2. Participants have spent at least 4 nights per week in the same household with the child in the previous month; 3 Participants are willing to accept the study arrangements and provide consent to participate in the study.

Inclusion criteria

1. Parents or other major caregivers (e.g., grandparents and legal guardians) of an adolescent child (10 to 19 years old) with/at risk of GD (defined as CSO-rated IGDS-SF9 score >=21); 2. Participants have spent at least 4 nights per week in the same household with the child in the previous month; 3 Participants are willing to accept the study arrangements and provide consent to participate in the study.

排除标准：

1. Parents/other major caregivers or their child have received similar CSO or GD-related intervention in the past 3 months; 2. Participants are unable to understand Cantonese Chinese.

Exclusion criteria：

1. Parents/other major caregivers or their child have received similar CSO or GD-related intervention in the past 3 months; 2. Participants are unable to understand Cantonese Chinese.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-10 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

Intervention group

样本量：

88

Group：

Intervention group

Sample size：

干预措施：

receive the CSO intervention plus educational materials on GD immediately following the baseline assessment and randomization.

干预措施代码：

Intervention：

receive the CSO intervention plus educational materials on GD immediately following the baseline assessment and randomization.

Intervention code：

组别：

Control group

样本量：

88

Group：

Control group

Sample size：

干预措施：

The control group will receive educational materials on GD immediately following the baseline assessment and randomization.

干预措施代码：

Intervention：

The control group will receive educational materials on GD immediately following the baseline assessment and randomization.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong  

市(区县)：

  

Country：

China 

Province：

Hong Kong  

City：

 

单位(医院)：

The Hong Kong Polytechnic University 

单位级别：

University 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Depression, anxiety, and stress

指标类型：

主要指标

Outcome：

Depression, anxiety, and stress

Type：

Primary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Depression Anxiety Stress Scale (DASS) Chinese version

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

Depression Anxiety Stress Scale (DASS) Chinese version

指标中文名：

Severity of the gaming disorder

指标类型：

次要指标

Outcome：

Severity of the gaming disorder

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Internet Gaming Disorder Scale – Short Form (IGDS-SF9) Chinese version

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

Internet Gaming Disorder Scale – Short Form (IGDS-SF9) Chinese version

指标中文名：

CSO-adolescent conflict

指标类型：

次要指标

Outcome：

CSO-adolescent conflict

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Parent-Child Conflict Tactics Scale (CTS-PC) Chinese version

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

Parent-Child Conflict Tactics Scale (CTS-PC) Chinese version

指标中文名：

Gaming-related CSO-adolescent conflict

指标类型：

次要指标

Outcome：

Gaming-related CSO-adolescent conflict

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

指标中文名：

CSO-adolescent relationship satisfaction

指标类型：

次要指标

Outcome：

CSO-adolescent relationship satisfaction

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

指标中文名：

Parental reflective functioning

指标类型：

次要指标

Outcome：

Parental reflective functioning

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Parental Reflective Functioning Questionnaire - Adolescent version (PRFQ)

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

Parental Reflective Functioning Questionnaire - Adolescent version (PRFQ)

指标中文名：

Emotional regulation

指标类型：

次要指标

Outcome：

Emotional regulation

Type：

Secondary indicator

测量时间点：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

测量方法：

Difficulties in Emotion Regulation Scale (DERS-16)

Measure time point of outcome：

Baseline before intervention, immediately post-intervention, 3-month follow-up, 6-month follow-up

Measure method：

Difficulties in Emotion Regulation Scale (DERS-16)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 25 岁 years
最大 Max age 65 岁 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 randomly assigned in a 1:1 allocation ratio to either the intervention group or the control group. A block randomization with a block size of 4 will be used. Within each block size of 4, two participants will be assigned to the intervention, and two will be allocated to the control.

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

Participants will be randomly assigned in a 1:1 allocation ratio to either the intervention group or the control group. A block randomization with a block size of 4 will be used. Within each block size of 4, two participants will be assigned to the intervention, and two will be allocated to the control.

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 for data analysts regarding the participants

Blinding：

Blinding for data analysts regarding the participants

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

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）：

None

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：

Data will be collected via Qualtrics or printed questionnaires, and data will be stored in the university's network drive, which is a stable and secure platform for data and file storage.

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

Data will be collected via Qualtrics or printed questionnaires, and data will be stored in the university's network drive, which is a stable and secure platform for data and file storage.

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：

  2026-02-05 11:45:35