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临床试验/NCT06766890
NCT06766890进行中(未招募)不适用

Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Psychological outcome: Depressive symptoms

研究概览

简要总结

Objectives: (1) to evaluate the feasibility of innovative school-based interventions on health outcomes (psychological well-being, depressive symptoms, anxiety symptoms, physical activity, sleep duration, and sleep quality) among primary students in the post-COVID-19 pandemic period; (2) to explore children's experience of intervention; (3) to evaluate the effects of innovative school-based (WeJoy + WeHop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children.

Method: Two phases of the study will be conducted, including feasibility pilot study and main study. In phase 1, a sample of 40 school children will be recruited from two community centers for feasibility test and semi-structured individual face-to-face interview. In phase 2, a total of 408 school children will be recruited from primary schools in Hong Kong. This study will adopt a 2 two-group pre and post-design. Participants are randomly assigned equally into 1 intervention group (WeJoy+WeHop) and 1 control group (Routine Extra curriculum Activity). Participants will be assessed at baseline and post-intervention. The outcomes are depressive symptoms, physical activities, and sleep quality, using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), the Chinese Version of the International Physical Activity Questionnaire (IPAQ-C), and the Chinese version of the Pittsburgh Sleep Quality Index (PSQI-C).

Data analysis: Descriptive and inferential statistics will be performed to examine the research objectives.

详细描述

The COVID-19 pandemic has altered children's lifestyles, calling for particular attention. Psychological problems, obesity, and sleep disturbance in children have become more prevalent throughout the COVID-19 outbreak. It is vital to develop preventative interventions to enhance psychological well-being, prevent obesity, and improve sleep health. Cognitive behavioural therapy (CBT) is effective in preventing psychological problems, obesity, and sleep problems in children. The provision of CBT faces obstacles such as a shortage of therapists, stigma, protracted wait times, and high costs. Evidence revealed that children prefer interventions with interactive, relatable, and game-like content to improve their engagement.

School-based CBT (WeJoy) allows children to recognize, change, and partake in pleasant activities based on the CBT model. The WeJoy comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring. Exergaming on the interactive floor (WeHop) using a portable interactive projector games system. The WeHop can gain a sense of autonomy, competence, and relatedness to help them regulate their emotions and maintain positive behaviours according to the Self-Determination Theory. Children participate in the interactive floor games by stepping on various targets and moving in response to the game's rules. Combining task division, cooperation, and taking turns constitutes the collaboration mechanism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary students ranged from primary 3 to 5 school children.
  • Obtained consent forms from their legal guardians.

排除标准

  • Primary students in primary 1 due to the adaptation of the new environment.
  • Primary 6 due to the preparation of the examinations for secondary schools.

结局指标

主要结局

Psychological outcome: Depressive symptoms

时间窗: baseline, pre-intervention and immediately after the intervention

Depressive symptoms will be assessed by the Chinese version of 20-item Center for Epidemiologic Studies Depression Scale for Children, CES-DC

次要结局

  • Physical activity(baseline, pre-intervention and immediately after the intervention)
  • Sleep outcomes include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction(baseline, pre-intervention and immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lau Ying

Professor

Chinese University of Hong Kong

研究点 (1)

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