- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766890
Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic (WeJoy+WeHop)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary students ranged from primary 3 to 5 school children.
- Obtained consent forms from their legal guardians.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: School-based Cognitive Behavior Therapy (WeJoy and exergaming on the interactive floor (WeHop)
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.
Each session provides 2 to 3 games per week for six weeks.
|
School-based CBT (WeJoy) comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring.
Exergaming on the interactive floor (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.
|
|
No Intervention: Usual class
Usual extra curriculum activities that are arranged by corresponding primary schools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological outcome: Depressive symptoms
Time Frame: 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
|
baseline, pre-intervention and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: baseline, pre-intervention and immediately after the intervention
|
Level of physical activities will be measured by the Chinese Version of 7-item International Physical Activity Questionnaire, IPAQ-C
|
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
Time Frame: baseline, pre-intervention and immediately after the intervention
|
Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction will be assessed by the Chinese version of 19-item Pittsburgh Sleep Quality Index, Chinese PSQI
|
baseline, pre-intervention and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV-2024-YL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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