Mental HealthNCT06423404
Active Breaks on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10
A study testing the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom in people with Mental Health and School-age Children, run by Universidad de Concepcion at 2 sites in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, School-age Children, School Health
- What is being tested?
- the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesChile
- Study dates
- 20 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- 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.
Who cannot join
- a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension.
- Students with severe intellectual disabilities prevented them from following the program instructions.
- Students participating simultaneously in another project with similar objectives.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Universidad de Concepción
Concepción, Biobio, 4030000
Universidad de Concepción
Concepción, Biobio, 4070371
About this study
Official title: 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.
Read more
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.
- Conditions
- Mental Health, School-age Children, School Health
- Being tested
- the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom
- Keywords
- active break, mental health, school climate, schoolchildren, physical fitness, multicentre randomized controlled trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroomBehavioural
Also called active break program
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Active Break group | Experimental | The Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom Receives: Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom |
| Control group: waiting list group | Other | 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. Receives: Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
School climate
School climate scale (ECLIS). 82 items with a four-level Likert-type response format (ranging from all to none).
Measured: From enrollment to the end of treatment at five months
Mental health
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.
Measured: From enrollment to the end of treatment at five months
Secondary outcomes (2)
Academic performance
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.
Measured: From enrollment to the end of treatment at five months
Physical health
This outcome will be measurement using the Alpha Fitness Test battery protocol, which includes measurements of cardiorespiratory, musculoskeletal, and motor condition.
Measured: From enrollment to the end of treatment at five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 Mar 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The project involves public primary schools with similar indices of school vulnerability (SVI) and medium to low socioeconomic status in the Biobío province, Chile. This selection was made because students attending these schools spend approximately eight hours per day (from 8:00 AM to 4:00 PM) with two 30-minute breaks and a longer one-hour lunch break. The intervention will focus on 1st to 4th grade classes. Six schools (three treatments and three controls) were recruited, estimating a sample size of 700 students (six schools × eight classes, with each class having 30 to 40 students).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423404
- Sponsor's protocol ID
- Universidad de Concepción
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023.
PubMed 38259740Robles-Campos A, Reyes-Molina D, Kracht-Suazo K, Cigarroa I, Carcamo-Oyarzun J, Martinez-Lopez N, Perez-Ruiz M, Grao-Cruces A, Mota J, Ruiz-Ariza A, Munoz Hinrichsen F, Garcia-Perez-de-Sevilla G, Celis-Morales C, Zapata-Lamana R. Effects of Video-Guided Active Breaks on Motor Competence of Schoolchildren with Special Education Needs. Children (Basel). 2025 Jun 21;12(7):820. doi: 10.3390/children12070820.
PubMed 40723013Zapata-Lamana R, Robles-Campos A, Reyes-Molina D, Rojas-Bravo J, Salcedo Lagos P, Chavez-Castillo Y, Gajardo-Aguayo J, Villalobos JV, Arias AM, Sanhueza-Campos C, Ibarra Mora J, Reyes-Amigo T, Cristi-Montero C, Sanchez-Oliva D, Ruiz-Hermosa A, Sanchez-Lopez M, Poblete-Valderrama F, Celis-Morales C, Martorell M, Carrasco-Marin F, Albornoz-Guerrero J, Parra-Rizo MA, Cigarroa I. Effects of 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. Front Physiol. 2024 Sep 12;15:1438555. doi: 10.3389/fphys.2024.1438555. eCollection 2024.
PubMed 39328832
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06423404
- Acronym / sponsor ID
- Universidad de Concepción
- Conditions
- Mental Health, School-age Children, School Health
- Keywords
- active break, mental health, school climate, schoolchildren, physical fitness, multicentre randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Universidad de ConcepcionUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The project involves public primary schools with similar indices of school vulnerability (SVI) and medium to low socioeconomic status in the Biobío province, Chile. This selection was made because students attending these schools spend approximately eight hours per day (from 8:00 AM to 4:00 PM) with two 30-minute breaks and a longer one-hour lunch break. The intervention will focus on 1st to 4th grade classes. Six schools (three treatments and three controls) were recruited, estimating a sample size of 700 students (six schools × eight classes, with each class having 30 to 40 students).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Active Break group | Experimental | Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroomThe Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom |
| Control group: waiting list group | Other | Behavioral: the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroomThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroomAlso: active break programThe \"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 | Behavioural | Control group: waiting list group, Experimental Group: Active Break group |
Primary outcome
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).
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.
2 secondary outcomes
Academic performance
Time frame: From enrollment to the end of treatment at five months
Physical health
Time frame: From enrollment to the end of treatment at five months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 38259740Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023.
- Derived from this study: PubMed 40723013Robles-Campos A, Reyes-Molina D, Kracht-Suazo K, Cigarroa I, Carcamo-Oyarzun J, Martinez-Lopez N, Perez-Ruiz M, Grao-Cruces A, Mota J, Ruiz-Ariza A, Munoz Hinrichsen F, Garcia-Perez-de-Sevilla G, Celis-Morales C, Zapata-Lamana R. Effects of Video-Guided Active Breaks on Motor Competence of Schoolchildren with Special Education Needs. Children (Basel). 2025 Jun 21;12(7):820. doi: 10.3390/children12070820.
- Derived from this study: PubMed 39328832Zapata-Lamana R, Robles-Campos A, Reyes-Molina D, Rojas-Bravo J, Salcedo Lagos P, Chavez-Castillo Y, Gajardo-Aguayo J, Villalobos JV, Arias AM, Sanhueza-Campos C, Ibarra Mora J, Reyes-Amigo T, Cristi-Montero C, Sanchez-Oliva D, Ruiz-Hermosa A, Sanchez-Lopez M, Poblete-Valderrama F, Celis-Morales C, Martorell M, Carrasco-Marin F, Albornoz-Guerrero J, Parra-Rizo MA, Cigarroa I. Effects of 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. Front Physiol. 2024 Sep 12;15:1438555. doi: 10.3389/fphys.2024.1438555. eCollection 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Experimental Group, receiving a 12-week program of video-guided active breaks with curricular content in the school classroom in people with Mental Health and School-age Children, run by Universidad de Concepcion at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School climate (time frame: From enrollment to the end of treatment at five months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423404, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.