- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06423404
Active Breaks on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10
Video-Guided Active Breaks With Curricular Content on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10: Study Protocol for a Multicentre Randomized Controlled Trial
Background: The incidence of mental health issues in children is increasing worldwide. In Chile, a recent surge in reports of deteriorating mental health among school populations and an increase in complaints related to poor school climate have been observed. Physical activity, specifically active breaks in the classroom, has shown positive effects on children's health. However, evidence regarding its impact on mental health and school climate in children is limited.
Objective: This article outlines the design, measurements, intervention program, and potential efficacy of the Active Classes + School Climate and Mental Health project. This project will assess a 12-week program of active breaks through guided videos with curricular content in the school classroom, and its effects on mental health and school climate as its primary contributions. Additionally, it will measure physical activity, physical fitness, motor competence, and academic performance in students aged 6 to 10 years in the Biobío province, Chile, as secondary contributions.
Methodology: It will be performed a multicenter randomized controlled trial involving students in the 1st to 4th grade (6 to 10 years old), encompassing a total of 48 classes across six schools (three intervention and three control) in the Biobío region, Chile. Video-guided active breaks will be implemented through the Active Classes; web platform, featuring curricular content, lasting 5 to 10 minutes and of moderate to vigorous intensity physical activity, twice a day, Monday to Friday, over a span of 12 weeks.
Expected Results/Discussion: To our knowledge, this will be the first study in Chile to evaluate the effects of incorporating video-guided active breaks with curricular content on mental health variables and school climate in schoolchildren. Thus, this study contributes to the scarce evidence on the effects of video-guided active breaks on mental health variables and school climate in schoolchildren worldwide. Additionally, it will provide crucial information about active teaching methodologies that have the potential to positively contribute to the well-being of students, thus addressing the problems of mental health and climate in Chilean schools.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Biobio
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Concepción, Biobio, Chile, 4030000
- Universidad de Concepcion
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Concepción, Biobio, Chile, 4070371
- Universidad de Concepcion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- a) Regular male or female students in primary education, from first to fourth grade, at a public school in one of the three provinces of the Biobío region, willing to participate and with parental consent.
b) Students spend at least 38 hours per week in classes (6.5 hours daily) and have at least two short breaks (10-15 minutes) per day.
Exclusion Criteria:
a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension.
b) Students with severe intellectual disabilities prevented them from following the program instructions.
c) Students participating simultaneously in another project with similar objectives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Active Break group
The Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom
|
The "Active Classes + School Climate and Mental Health" program was crafted following a comprehensive review by the research team on active breaks in the child school population.
Based on the findings of this review, the optimal type and duration of intervention, frequency and intensity of the most effective exercises, and video-guided modalities with curricular content for active breaks will be established.
Subsequently, a collaborative network was formed, involving researchers from education, sports science, social sciences, medicine, primary school teachers within the Chilean public school system, teams of educational leaders, parents, guardians, pedagogy students, and graduate students.
The purpose was to create a team that systematically supports the development of various stages of the project from a multi and interdisciplinary perspective
Other Names:
|
|
Other: Control group: waiting list group
The Control Group, receiving the same intervention as the experimental group after the final data collection.
During the time of the intervention, the waiting list group will receive the usual classes.
|
The "Active Classes + School Climate and Mental Health" program was crafted following a comprehensive review by the research team on active breaks in the child school population.
Based on the findings of this review, the optimal type and duration of intervention, frequency and intensity of the most effective exercises, and video-guided modalities with curricular content for active breaks will be established.
Subsequently, a collaborative network was formed, involving researchers from education, sports science, social sciences, medicine, primary school teachers within the Chilean public school system, teams of educational leaders, parents, guardians, pedagogy students, and graduate students.
The purpose was to create a team that systematically supports the development of various stages of the project from a multi and interdisciplinary perspective
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School climate
Time Frame: From enrollment to the end of treatment at five months
|
School climate scale (ECLIS).
82 items with a four-level Likert-type response format (ranging from all to none).
|
From enrollment to the end of treatment at five months
|
|
Mental health
Time Frame: From enrollment to the end of treatment at five months
|
This outcome will be measurement with School Self-Esteem Test (SSET) and Self-report of socioemotional well-being.
The raw score sum is transformed into a T score according to age norms, categorizing students as follows: normal self-esteem, ≥ 40 points; low self-esteem, 30-39 points; and very low self-esteem, ≤ 29 points.
|
From enrollment to the end of treatment at five months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic performance
Time Frame: From enrollment to the end of treatment at five months
|
The academic performance of the students will be measured using Integral Learning Diagnosis.
For this study, only the reading test (2nd, 3rd, and 4th grades) and mathematics test (3rd and 4th grades) were used, measured at the beginning and end of the school year.
The grading scale is from 1 as a minimum value to 7 as a maximum value.
|
From enrollment to the end of treatment at five months
|
|
Physical health
Time Frame: From enrollment to the end of treatment at five months
|
This outcome will be measurement using the Alpha Fitness Test battery protocol, which includes measurements of cardiorespiratory, musculoskeletal, and motor condition.
|
From enrollment to the end of treatment at five months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic
Time Frame: From enrollment to the end of treatment at five months
|
The sociodemographic instrument includes information related to characteristics of the students and their parents (i.e. economic level, educational level).
In addition, physical activity and sedentary behavior, eating habits, sleeping and screen habits, type of transportation to the educational center.
|
From enrollment to the end of treatment at five months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
Other Study ID Numbers
- Universidad de Concepción
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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