【ChiCTR2600121600】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

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基本信息

登记号

ChiCTR2600121600

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-04-01

临床申请受理号

靶点

适应症

儿童心理健康

试验通俗题目

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

试验专业题目

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

申办单位信息

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

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.

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.

试验项目经费来源

香港理工大学应用社会科学系内部研究基金, 项目ID: P0046190

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-03-31

试验终止时间

2026-12-31

是否属于一致性

入选标准

(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.；

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.；

研究者信息

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试验机构

华东师范大学；香港理工大学应用社会学系

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