ChiCTR2600121600 版本V1.0 版本创建时间2026/04/01 11:05:21 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：

 ChiCTR2600121600 

最近更新日期：

Date of Last Refreshed on：

 2026-04-01 11:05:09 

注册时间：

Date of Registration：

 2026-04-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

父母干预改善中国城市低收入家庭儿童心理健康：一项混合方法的随机对照试验

Public title：

Parent-Based Interventions to Improve the Mental Health of Urban Chinese Children from Low-Income Families: A Mixed-Methods Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

父母干预改善中国城市低收入家庭儿童心理健康：一项混合方法的随机对照试验

Scientific title：

Parent-Based Interventions to Improve the Mental Health of Urban Chinese Children from Low-Income Families: A Mixed-Methods 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：

任遥翔 

研究负责人：

于璐 

Applicant：

Ren Yaoxiang 

Study leader：

Yu Lu 

申请注册联系人电话：

Applicant telephone：

 +852 5667 2322

研究负责人电话：

Study leader's
telephone：

+852 2766 4859

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：

 yaoxiang.ren@connect.polyu.hk

研究负责人电子邮件：

Study leader's E-mail：

 lu.yu@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：

香港, 九龙, 红磡, 香港理工大学, 应用社会学系, GH403室

研究负责人通讯地址：

香港, 九龙, 红磡, 香港理工大学, 应用社会学系, HJ406室

Applicant address：

GH403, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

Study leader's address：

HJ406, Department of Applied Social Sciences, The Hong Kong Polytechnic University, 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：

香港理工大学应用社会学系

Applicant's institution：

Department of Applied Social Sciences, The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大学应用社会学系

Affiliation of the Leader：

Department of Applied Social Sciences, The Hong Kong Polytechnic University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 HSEARS20260309002

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：

香港理工大学研究伦理审查委员会

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：

 2026-03-12 00:00:00

伦理委员会联系人：

Cherrie Mok

Contact Name of the ethic committee：

Cherrie Mok

伦理委员会联系地址：

香港，九龙，红磡，香港理工大学研究及创新办公室，GH平台，GH254室

Contact Address of the ethic committee：

GH254, GH Podium Annexe, Research and Innovation Office, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2766 6379

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 institutional.review.board@polyu.edu.hk

研究实施负责（组长）单位：

华东师范大学； 香港理工大学应用社会学系

Primary sponsor：

East China Normal University; Department of Applied Social Sciences, The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

上海市闵行区东川路500号

Primary sponsor's address：

500 Dongchuan Road, Minhang District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港理工大学应用社会学系

具体地址：

香港, 九龙, 红磡, 香港理工大学, 应用社会学系

Institution
hospital：

Department of Applied Social Sciences, The Hong Kong Polytechnic University

Address：

Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

经费或物资来源：

香港理工大学应用社会科学系内部研究基金, 项目ID: P0046190

Source(s) of funding：

Internal Research Fund of the Department of Applied Social Sciences, The Hong Kong Polytechnic University, Project ID: P0046190

研究疾病：

儿童心理健康  

Target disease：

Children 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The current study employed a mixed-methods randomized controlled trial (RCT) to evaluate the effectiveness of a culturally-tailored parent-based intervention, which aims at improving the mental health of urban Chinese Children from low-income families. There are two study objectives: 1) to comprehensively evaluate the intervention's effectiveness in improving child mental health and parental outcomes, and 2) to explore demographic or contextual characteristics that may moderate its effects.  

Objectives of Study：

The current study employed a mixed-methods randomized controlled trial (RCT) to evaluate the effectiveness of a culturally-tailored parent-based intervention, which aims at improving the mental health of urban Chinese Children from low-income families. There are two study objectives: 1) to comprehensively evaluate the intervention's effectiveness in improving child mental health and parental outcomes, and 2) to explore demographic or contextual characteristics that may moderate its effects.

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) Be a primary caregiver who lives with primary school-aged child; (2) Have no current diagnosis of mental health disorders, intellectual disabilities, or physical disabilities requiring specialized care (applies to both the target child and siblings or parents); (3) Belong to a middle or low socioeconomic status as assessed by the Home Socioeconomic Status Scale; (4) Voluntarily agree to participate in the parenting group program and to comply with the randomization procedure, sign an informed consent form, and voluntarily agree to complete all required assessments. (5) Not currently participating in any other structured parenting intervention or psychological treatment.

Inclusion criteria

(1) Be a primary caregiver who lives with primary school-aged child; (2) Have no current diagnosis of mental health disorders, intellectual disabilities, or physical disabilities requiring specialized care (applies to both the target child and siblings or parents); (3) Belong to a middle or low socioeconomic status as assessed by the Home Socioeconomic Status Scale; (4) Voluntarily agree to participate in the parenting group program and to comply with the randomization procedure, sign an informed consent form, and voluntarily agree to complete all required assessments. (5) Not currently participating in any other structured parenting intervention or psychological treatment.

排除标准：

(1) The caregiver is not a primary caregiver or does not reside in the same household as a primary school-aged child. (2) The target child, their siblings, or either parent has a current diagnosis of a mental health disorder, an intellectual disability, or a physical disability that necessitates specialized care. (3) Belong to a high socioeconomic status as assessed by the Home Socioeconomic Status Scale; (4) Does not voluntarily agree to participate in the parenting group program, is unwilling to comply with the randomization procedure, or refuses to sign the informed consent form. (5) Currently participating in another structured parenting intervention or psychological study that could confound the results of this trial.

Exclusion criteria：

(1) The caregiver is not a primary caregiver or does not reside in the same household as a primary school-aged child. (2) The target child, their siblings, or either parent has a current diagnosis of a mental health disorder, an intellectual disability, or a physical disability that necessitates specialized care. (3) Belong to a high socioeconomic status as assessed by the Home Socioeconomic Status Scale; (4) Does not voluntarily agree to participate in the parenting group program, is unwilling to comply with the randomization procedure, or refuses to sign the informed consent form. (5) Currently participating in another structured parenting intervention or psychological study that could confound the results of this trial.

研究实施时间：

Study execute time：

从 From 2026-03-31 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-01 00:00:00 至 To 2026-04-17 00:00:00

干预措施：

Interventions：

组别：

Intervention Group

样本量：

 44

Group：

Intervention Group

Sample size：

干预措施：

The intervention employed a multi-family group format, integrating both educational and experiential learning methods. Core activities include: (1) psychoeducation with discussion, (2) in-session skills practice, (3) collaborative problem-solving, (4) home-based exercises to reinforce learning.

干预措施代码：

Intervention：

The intervention employed a multi-family group format, integrating both educational and experiential learning methods. Core activities include: (1) psychoeducation with discussion, (2) in-session skills practice, (3) collaborative problem-solving, (4) home-based exercises to reinforce learning.

Intervention code：

组别：

Wait-list Control Group

样本量：

 44

Group：

Wait-list Control Group

Sample size：

干预措施：

No active treatment. Participants will receive a manual on eye health.

干预措施代码：

Intervention：

No active treatment. Participants will receive a manual on eye health.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Shanghai 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 Jingdong Primary School 

单位级别：

 Primary School 

Institution
hospital：

Jingdong Primary School

Level of the institution：

Primary School

国家：

 China

省(直辖市)：

 Shanghai 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 Tangwan Primary School 

单位级别：

 Primary School 

Institution
hospital：

Tangwan Primary School

Level of the institution：

Primary School

测量指标：

Outcomes：

指标中文名：

Child mental health

指标类型：

主要指标

Outcome：

Child mental health

Type：

Primary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Child positive and negative affect

指标类型：

主要指标

Outcome：

Child positive and negative affect

Type：

Primary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

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：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Parent-Child Relationship

指标类型：

次要指标

Outcome：

Parent-Child Relationship

Type：

Secondary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Parenting practices

指标类型：

次要指标

Outcome：

Parenting practices

Type：

Secondary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Parent mental health

指标类型：

次要指标

Outcome：

Parent mental health

Type：

Secondary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Child subjective happiness

指标类型：

次要指标

Outcome：

Child subjective happiness

Type：

Secondary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Mindfulness in Parenting

指标类型：

次要指标

Outcome：

Mindfulness in Parenting

Type：

Secondary indicator

测量时间点：

Baseline, post-intervention, 3-month follow-up

测量方法：

Measure time point of outcome：

Baseline, post-intervention, 3-month follow-up

Measure method：

指标中文名：

Program evaluation scale

指标类型：

附加指标

Outcome：

Program evaluation scale

Type：

Additional indicator

测量时间点：

Post-intervention

测量方法：

Measure time point of outcome：

Post-intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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 70 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）：

The randomization process will be managed by an independent Research Assistant (RA) who is not involved in participant recruitment, baseline assessments, intervention delivery, or outcome evaluation. Participants will be individually randomized in a 1:1 ratio to either the intervention group or the control group using a simple randomization procedure. The random allocation sequence will be generated by the RA using R via R Studio.

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

The randomization process will be managed by an independent Research Assistant (RA) who is not involved in participant recruitment, baseline assessments, intervention delivery, or outcome evaluation. Participants will be individually randomized in a 1:1 ratio to either the intervention group or the control group using a simple randomization procedure. The random allocation sequence will be generated by the RA using R via R Studio.

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：

Due to the nature of the intervention, the researcher responsible for implementation fidelity, the facilitators, and participants will not be blinded. However, blinding is maintained at other levels to reduce bias. The research assistant responsible for generating the random allocation sequence is blinded to participant characteristics and outcomes. During data analysis, group identities will be coded so that the data analyst remains blinded to which group received the intervention or control. Additionally, the project leader will be blinded to group allocation throughout the study to ensure unbiased oversight.

Blinding：

Due to the nature of the intervention, the researcher responsible for implementation fidelity, the facilitators, and participants will not be blinded. However, blinding is maintained at other levels to reduce bias. The research assistant responsible for generating the random allocation sequence is blinded to participant characteristics and outcomes. During data analysis, group identities will be coded so that the data analyst remains blinded to which group received the intervention or control. Additionally, the project leader will be blinded to group allocation throughout the study to ensure unbiased oversight.

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）：

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

Data will be collected through paper-based questionnaires and interviews. All information obtained from participants will be kept strictly confidential. All paper-based and electronic data, including questionnaires, interview transcripts, and other study documents, will be stored on password-protected devices. Paper records, such as informed consent forms, will be kept in a locked filing cabinet accessible only to the research team. Personal identifying information (e.g., names and contact details) will be stored separately from research data to further protect participant privacy.

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：

  2026-04-01 11:05:09