School-based InterventionActiveClass-BHNCT06820632
School-based Physical Education in Bhutan for Physical Fitness and Socio-emotional Competencies in Adolescents
A study testing Enhanced physical education and HPE Standard curriculum in people with School-based Intervention, run by Centre Hospitalier Universitaire Vaudois at 1 site in Bhutan.
Trial summary
Despite global evidence supporting the benefits of PE in promoting socio-emotional skills, much of the research has focused on countries where PE is a mandatory part of the curriculum. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- School-based Intervention
- What is being tested?
- Enhanced physical education and HPE Standard curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteBhutan
- Study dates
- 10 Feb 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolment in participating schools: Students must be enrolled in upper primary school classes (grades 7 and 8) in one of the three participating school.
- Regular school attendance: Students must attend school regularly to ensure consistent exposure to the intervention (min 80% of the courses).
- Parental consent: Written informed consent from a parent or guardian.
- Verbal assent from the child, indicating their willingness to participate.
Who cannot join
- Inability to participate in physical education courses: Students unable to participate in physical education classes due to medical or other significant reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bhutan1 site
Paro College of Education, Bhutan
Paro, Paro Dzongkhag, CC8C+FV2
About this study
Official title: From Classrooms to Playgrounds in Bhutan: Evaluating the Role of School-based Physical Education on Physical Fitness, Socio-emotional Competencies and Well-being in Young Adolescents
Despite global evidence supporting the benefits of PE in promoting socio-emotional skills, much of the research has focused on countries where PE is a mandatory part of the curriculum. In contrast, Bhutan's Health and Physical Education (HPE) program is limited, with many schools lacking a structured curriculum and dedicated PE educators. This project aims to evaluate the impact of an enhanced school-based physical education (PE) program on physical fitness, socio-emotional competencies, and well-being among upper primary school students in Bhutan.
This project is a methodological collaboration between the Centre Hospitalier Universitaire Vaudois in Switzerland and the Paro College of Education and Royal Thimphu College in Bhutan.
Read more
Two public urban schools will be randomly assigned to either the "enhanced physical education program" or "standard curriculum" condition. An additional "control school", with no physical education, will be included in the study but not in the randomisation process for feasibility concern. A total of 360 young adolescents (120 per school, aged 12-14) will be enrolled. Baseline data on individual characteristics such as age, gender, and socio-economic status will be collected through self- and parent-reported questionnaires. Primary outcome measures include physical fitness assessed by PE teachers using various metrics, as well as socio-emotional competencies and well-being evaluated through standardised self- and parent-reported questionnaires. Data will be analysed using an intention-to-treat approach.
This project offers a unique opportunity to explore the international impact of PE within Bhutan's socio-cultural context.
Read the detailed description
Evidence shows that physical activity, including school-based physical education (PE), supports children's socio-emotional competencies and well-being, including enhancing self-regulation and reducing anxiety and depression. These positive outcomes often vary based on individual factors, including gender and socio-economic status. Given the amount of time children spend in school, this setting provides an ideal platform for enhancing their socio-emotional competencies and well-being through diverse PE opportunities. To date, most research on the association between PE and socio-emotional competencies has been conducted in countries where PE is a mandatory component of the school curriculum, such as those in Europe, the United States, and Australia. Bhutan, a Himalayan Buddhist country with a rich cultural heritage, has seen rapid social changes over the past 20-30 years. Rapid modernisation has led to lifestyle changes among youth, contributing to increasing social issues, sedentary habits and mental health challenges. School-based PE, known as Health and Physical Education (HPE), is limited to a single weekly hour and is highly dependent on the motivation of individual teachers and schools. Anecdotal evidence suggests that many schools do not have a dedicated time slot for HPE. HPE also faces obstacles, including the absence of a structured curriculum, limited trained PE educators, and a lack of prioritisation compared to other subjects.
This project aims to evaluate the impact of a school-based enhanced PE program on physical fitness, socio-emotional competencies and well-being in upper primary school students in Bhutan, compared to a school with HPE standard curriculum and a school with no PE.
This project is a methodological collaboration between the Centre Hospitalier Universitaire Vaudois in Switzerland (Dr Vanessa Siffredi, Dr Russia Hà-Vinh Leuchter) and the Paro College of Education and Royal Thimphu College in Bhutan (Prof. Kezang Sherab and Dr Pema Chopel). The Bhutanese team will implement the intervention and oversee on-site data collection, with the Swiss team providing methodological and statistical support.
Using a randomised controlled trial design, we will assign two urban public schools to either an "enhanced PE", grounded in Bhutan's health and physical education curriculum, or a "HPE standard curriculum" group. An additional "control school", without PE classes, will be included outside of the randomisation for feasibility concern. The study anticipates enrolling n=120 young adolescents per school (total n=360, ages 12- to 14-year-old). The enhanced PE group will receive two 90-minute sessions weekly for 5 months. The enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities. Baseline individual characteristics (e.g., age, gender, socio-economic status, frequency of physical activity) will be collected pre-intervention via self- and parent-reported questionnaires. Primary outcomes, including physical fitness, socio-emotional skills, well-being, will be measured pre- and post-intervention. Physical fitness will be assessed by PE teachers (muscular strength, muscular endurance, flexibility, cardiorespiratory endurance, balance, coordination, agility, speed and power). Socio-emotional competencies and well-being will be evaluated in the young adolescents using standardised self- and parent-reported questionnaires.
This project offers a unique opportunity to evaluate the international impacts of PE on adolescents' socio-emotional competencies and well-being, especially within Bhutan's distinctive socio-cultural context. Given PE's low prioritisation, findings from this study will be valuable for guiding the Bhutanese national sport curriculum. More broadly, i will contribute to global research on PE and its role in fostering socio-emotional competencies and well-being in youth.
- Conditions
- School-based Intervention
- Being tested
- Enhanced physical education, HPE Standard curriculum
- Keywords
- physical education, adolescence, socio-emotional competencies, well-being, bhutan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced physical educationBehavioural
The "Enhanced physical education" is based on the Health and Physical Education (HPE) Curriculum Framework developed by the Bhutanese Ministry of Education and well-document in the 2022 edition, www.education.gov.bt. The enhanced PE group will follow closely the description of the HPE curriculum and receive two 90-minute sessions weekly for 5 months. According to the HEP curriculum, the enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities.
HPE Standard curriculumBehavioural
Health and physical education (HPE) standard curriculum includes roughly one hour per week of general physical education, typically involving activities like football and basketball.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced physical education | Experimental | The "Enhanced physical education" arm is based on the Health and Physical Education Curriculum Framework developed by the Bhutanese Ministry of Education and well-document in the 2022 edition, www.education.gov.bt. The enhanced PE group will receive two 90-minute sessions weekly for 5 months. The enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities. Receives: Behavioral: Enhanced physical education |
| Health and Physical Education (HPE) standard curriculum | Active comparator | Health and Physical Education (HPE) standard curriculum is mainly a physical education class limited to a single weekly hour and is highly dependent on the motivation of individual teachers and schools. Receives: Behavioral: HPE Standard curriculum |
| Control school | No intervention | A school without physical education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-emotional competencies: Self-reported, Strength and Difficulty Questionnaire (SDQ)
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Strength and Difficulty Questionnaire (SDQ).
The SDQ is a well-validated 25-item questionnaire designed to assess behavioural problems in children and adolescents aged 4 to 16. It consists of: a) four subscales, emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems (min=0, max=10) with higher scores indicate more difficulties, b) an additional prosocial behavior subscale with higher scores indicate better outcomes in prosocial behavior, and c) a total difficulties score, based on emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems, is also measured with higher scores reflecting greater behavioral difficulties (min=0, max=40).
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Self-reported, Self-Compassion Scale
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Self-Compassion Scale.
This 26-item scale measures self-compassion across six key dimensions: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Each item is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The total score ranges from 26 to 130, with higher scores indicating greater self-compassion and emotional resilience.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Self-reported, Empathy Questionnaire for children and adolescents
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Empathy Questionnaire for children and adolescents.
This 15-item scale assesses empathy in adolescents across five dimensions: emotional contagion, self-awareness, perspective-taking, emotional regulation, and empathic action. Each item is scored on a 4-point Likert scale, resulting in a total score ranging from 15 to 60 with higher scores indicate stronger empathy abilities.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Self-reported, Self-Efficacy Questionnaire for Youth
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Self-Efficacy Questionnaire for Youth.
This brief questionnaire is designed to assess self-efficacy in youths. It consists of 10 items, each rated on a 5-point Likert scale. The Self-Efficacy Questionnaire for Youth gives a total score that range from 10 to 50, with higher scores reflecting better perceived self-efficacy.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Parent-reported, Strength and Difficulty Questionnaire (SDQ)
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Strength and Difficulty Questionnaire (SDQ). The SDQ is a well-validated 25-item questionnaire designed to assess behavioural problems in children and adolescents aged 4 to 16. It consists of: a) four subscales, emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems (min=0, max=10) with higher scores indicate more difficulties, b) an additional prosocial behavior subscale with higher scores indicate better outcomes in prosocial behavior, and c) a total difficulties score, based on emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems, is also measured with higher scores reflecting greater behavioral difficulties (min=0, max=40).
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Parent-reported, Behaviour Rating Inventory of Executive Function (BRIEF)
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Behaviour Rating Inventory of Executive Function (BRIEF), Behavioural Regulation Scale.
The Behavioural Regulation Scale from the BRIEF consists of 16 items designed to evaluate a child's ability to control their behaviour and emotions, such as impulse control, emotional regulation, and the capacity to shift between tasks or thoughts.
The Behavioural Regulation Scale is typically reported as T-scores (M=50, SD=10) with higher scores reflect more executive difficulties.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies: Parent-reported, Social Skills Improvement System (SSIS)
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Social Skills Improvement System (SSIS), Social Skills Scale. The Social Skills Scale from the SSIS consists of 46 items, each rated to reflect the frequency and quality of specific social behaviours in different contexts. It is designed to assess a range of social behaviours that contribute to positive interactions and relationships. This scale evaluates various domains, including communication, cooperation, assertion, responsibility, empathy, engagement, and self-control.
The instrument yields norm-referenced scores for the Social Skills Scale (M = 100, SD = 15) with higher scores reflecting better social competence and more positive social interactions.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Well-being: Self-reported, KIDSCREEN-27
Well-being will be evaluated in young adolescents using the standardised self-reported KIDSCREEN-27 questionnaire.
The KIDSCREEN-27 contains 27 items, with responses capturing the frequency or intensity of experiences related to the child's health and well-being over the past week. It is designed to measure health-related quality of life and it assesses five dimensions: Physical Well-being, Psychological Well-being, Autonomy \& Parent Relations, Social Support \& Peers, and School Environment. For each dimension, scores are typically transformed to a continuous scale ranging from 0 to 100, with higher scores reflecting better outcomes.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Well-being: Parent-reported, KIDSCREEN-27
Well-being will be evaluated in young adolescents using the standardised parent-reported KIDSCREEN-27 questionnaire.
The KIDSCREEN-27 contains 27 items, with responses capturing the frequency or intensity of experiences related to the child's health and well-being over the past week. It is designed to measure health-related quality of life and it assesses five dimensions: Physical Well-being, Psychological Well-being, Autonomy \& Parent Relations, Social Support \& Peers, and School Environment. For each dimension, scores are typically transformed to a continuous scale ranging from 0 to 100, with higher scores reflecting better outcomes.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Push-up measurement
Push-up (total number of repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Sit-Up/Curl-Up test
Sit-Up/Curl-Up Test (total number of repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Sit and Reach test
Sit and Reach Test (in cm) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Run in Place test
Run in Place for 90 seconds (record number of heart rate in 30 seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
One foot balance test
One foot balance (in seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Basic paper ball bounce test
Basic paper ball bounce test (bounce the ball at least three times with each hand) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Left-right paper ball bounce test
Bounce the ball back and forth between the right and left hands (maximum number of bouncing) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Shuttle Run test
Shuttle Run test (9 meters side move repetitions - number of times/repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Dash test
50 meters Dash test (in seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Standing Broad Jump test
Standing Broad Jump (in cm) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Measured: Pre-intervention (baseline) and 16 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (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 School-based InterventionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two public urban schools will be randomly assigned to either the "enhanced physical education program" or "standard curriculum" condition. An additional "control school", with no physical education, will be included in the study but not in the randomisation process for feasibility concern.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Paro College of Education, Royal Thimphu College
- Responsible party
- Principal investigator, Vanessa Siffredi, Centre Hospitalier Universitaire Vaudois
- Investigators
- Kezang Sherab, PhD, Principal investigator, Paro College of Education & Royal Thimphu College, BhutanVanessa Siffredi, PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820632
- Sponsor's protocol ID
- CIRSport2025
- Acronym
- ActiveClass-BH
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available to researchers who provide a proposal that supports the aims of the approved study. Proposals should be submitted to kezangsherab.pce@rub.edu.bt
Publications
Spruit A, Assink M, van Vugt E, van der Put C, Stams GJ. The effects of physical activity interventions on psychosocial outcomes in adolescents: A meta-analytic review. Clin Psychol Rev. 2016 Apr;45:56-71. doi: 10.1016/j.cpr.2016.03.006. Epub 2016 Apr 3.
PubMed 27064552Choden U, Sherab K, Howard J. Experience of bullying among Bhutanese college students: implications for teacher formation programmes. Int J Adolesc Med Health. 2019 Nov 25;34(1). doi: 10.1515/ijamh-2019-0087.
PubMed 31760378Lubans D, Richards J, Hillman C, Faulkner G, Beauchamp M, Nilsson M, Kelly P, Smith J, Raine L, Biddle S. Physical Activity for Cognitive and Mental Health in Youth: A Systematic Review of Mechanisms. Pediatrics. 2016 Sep;138(3):e20161642. doi: 10.1542/peds.2016-1642. Epub 2016 Aug 19.
PubMed 27542849
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Classrooms to Playgrounds in Bhutan: Evaluating the Role of School-based Physical Education on Physical Fitness, Socio-emotional Competencies and Well-being in Young Adolescents
- ClinicalTrials.gov ID
- NCT06820632
- Acronym / sponsor ID
- ActiveClass-BH / CIRSport2025
- Conditions
- School-based Intervention
- Keywords
- physical education, adolescence, socio-emotional competencies, well-being, bhutan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Paro College of Education, Royal Thimphu College
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
Despite global evidence supporting the benefits of PE in promoting socio-emotional skills, much of the research has focused on countries where PE is a mandatory part of the curriculum. In contrast, Bhutan's Health and Physical Education (HPE) program is limited, with many schools lacking a structured curriculum and dedicated PE educators. This project aims to evaluate the impact of an enhanced school-based physical education (PE) program on physical fitness, socio-emotional competencies, and well-being among upper primary school students in Bhutan.
This project is a methodological collaboration between the Centre Hospitalier Universitaire Vaudois in Switzerland and the Paro College of Education and Royal Thimphu College in Bhutan.
Two public urban schools will be randomly assigned to either the "enhanced physical education program" or "standard curriculum" condition. An additional "control school", with no physical education, will be included in the study but not in the randomisation process for feasibility concern. A total of 360 young adolescents (120 per school, aged 12-14) will be enrolled. Baseline data on individual characteristics such as age, gender, and socio-economic status will be collected through self- and parent-reported questionnaires. Primary outcome measures include physical fitness assessed by PE teachers using various metrics, as well as socio-emotional competencies and well-being evaluated through standardised self- and parent-reported questionnaires. Data will be analysed using an intention-to-treat approach.
This project offers a unique opportunity to explore the international impact of PE within Bhutan's socio-cultural context.
Detailed description
Evidence shows that physical activity, including school-based physical education (PE), supports children's socio-emotional competencies and well-being, including enhancing self-regulation and reducing anxiety and depression. These positive outcomes often vary based on individual factors, including gender and socio-economic status. Given the amount of time children spend in school, this setting provides an ideal platform for enhancing their socio-emotional competencies and well-being through diverse PE opportunities. To date, most research on the association between PE and socio-emotional competencies has been conducted in countries where PE is a mandatory component of the school curriculum, such as those in Europe, the United States, and Australia. Bhutan, a Himalayan Buddhist country with a rich cultural heritage, has seen rapid social changes over the past 20-30 years. Rapid modernisation has led to lifestyle changes among youth, contributing to increasing social issues, sedentary habits and mental health challenges. School-based PE, known as Health and Physical Education (HPE), is limited to a single weekly hour and is highly dependent on the motivation of individual teachers and schools. Anecdotal evidence suggests that many schools do not have a dedicated time slot for HPE. HPE also faces obstacles, including the absence of a structured curriculum, limited trained PE educators, and a lack of prioritisation compared to other subjects.
This project aims to evaluate the impact of a school-based enhanced PE program on physical fitness, socio-emotional competencies and well-being in upper primary school students in Bhutan, compared to a school with HPE standard curriculum and a school with no PE.
This project is a methodological collaboration between the Centre Hospitalier Universitaire Vaudois in Switzerland (Dr Vanessa Siffredi, Dr Russia Hà-Vinh Leuchter) and the Paro College of Education and Royal Thimphu College in Bhutan (Prof. Kezang Sherab and Dr Pema Chopel). The Bhutanese team will implement the intervention and oversee on-site data collection, with the Swiss team providing methodological and statistical support.
Using a randomised controlled trial design, we will assign two urban public schools to either an "enhanced PE", grounded in Bhutan's health and physical education curriculum, or a "HPE standard curriculum" group. An additional "control school", without PE classes, will be included outside of the randomisation for feasibility concern. The study anticipates enrolling n=120 young adolescents per school (total n=360, ages 12- to 14-year-old). The enhanced PE group will receive two 90-minute sessions weekly for 5 months. The enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities. Baseline individual characteristics (e.g., age, gender, socio-economic status, frequency of physical activity) will be collected pre-intervention via self- and parent-reported questionnaires. Primary outcomes, including physical fitness, socio-emotional skills, well-being, will be measured pre- and post-intervention. Physical fitness will be assessed by PE teachers (muscular strength, muscular endurance, flexibility, cardiorespiratory endurance, balance, coordination, agility, speed and power). Socio-emotional competencies and well-being will be evaluated in the young adolescents using standardised self- and parent-reported questionnaires.
This project offers a unique opportunity to evaluate the international impacts of PE on adolescents' socio-emotional competencies and well-being, especially within Bhutan's distinctive socio-cultural context. Given PE's low prioritisation, findings from this study will be valuable for guiding the Bhutanese national sport curriculum. More broadly, i will contribute to global research on PE and its role in fostering socio-emotional competencies and well-being in youth.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two public urban schools will be randomly assigned to either the "enhanced physical education program" or "standard curriculum" condition. An additional "control school", with no physical education, will be included in the study but not in the randomisation process for feasibility concern.
| Arm | Type | Receives |
|---|---|---|
| Enhanced physical education | Experimental | Behavioral: Enhanced physical educationThe "Enhanced physical education" arm is based on the Health and Physical Education Curriculum Framework developed by the Bhutanese Ministry of Education and well-document in the 2022 edition, www.education.gov.bt. The enhanced PE group will receive two 90-minute sessions weekly for 5 months. The enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities. |
| Health and Physical Education (HPE) standard curriculum | Active comparator | Behavioral: HPE Standard curriculumHealth and Physical Education (HPE) standard curriculum is mainly a physical education class limited to a single weekly hour and is highly dependent on the motivation of individual teachers and schools. |
| Control school | No intervention | –A school without physical education classes |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Enrolment in participating schools: Students must be enrolled in upper primary school classes (grades 7 and 8) in one of the three participating school.
- Regular school attendance: Students must attend school regularly to ensure consistent exposure to the intervention (min 80% of the courses).
- Parental consent: Written informed consent from a parent or guardian.
- Verbal assent from the child, indicating their willingness to participate.
Key exclusion criteria (1 listed)
- Inability to participate in physical education courses: Students unable to participate in physical education classes due to medical or other significant reasons.
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 |
|---|---|---|
| Enhanced physical educationThe "Enhanced physical education" is based on the Health and Physical Education (HPE) Curriculum Framework developed by the Bhutanese Ministry of Education and well-document in the 2022 edition, www.education.gov.bt. The enhanced PE group will follow closely the description of the HPE curriculum and receive two 90-minute sessions weekly for 5 months. According to the HEP curriculum, the enhanced PE program incorporate both PE with socio-emotional competencies, such as self-regulation, self- and social-awareness, empathy-building exercises, and cooperation activities. | Behavioural | Enhanced physical education |
| HPE Standard curriculumHealth and physical education (HPE) standard curriculum includes roughly one hour per week of general physical education, typically involving activities like football and basketball. | Behavioural | Health and Physical Education (HPE) standard curriculum |
Primary outcome
Socio-emotional competencies: Self-reported, Strength and Difficulty Questionnaire (SDQ)
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Strength and Difficulty Questionnaire (SDQ). The SDQ is a well-validated 25-item questionnaire designed to assess behavioural problems in children and adolescents aged 4 to 16. It consists of: a) four subscales, emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems (min=0, max=10) with higher scores indicate more difficulties, b) an additional prosocial behavior subscale with higher scores indicate better outcomes in prosocial behavior, and c) a total difficulties score, based on emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems, is also measured with higher scores reflecting greater behavioral difficulties (min=0, max=40).
Socio-emotional competencies: Self-reported, Self-Compassion Scale
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Self-Compassion Scale. This 26-item scale measures self-compassion across six key dimensions: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Each item is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). The total score ranges from 26 to 130, with higher scores indicating greater self-compassion and emotional resilience.
Socio-emotional competencies: Self-reported, Empathy Questionnaire for children and adolescents
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Empathy Questionnaire for children and adolescents. This 15-item scale assesses empathy in adolescents across five dimensions: emotional contagion, self-awareness, perspective-taking, emotional regulation, and empathic action. Each item is scored on a 4-point Likert scale, resulting in a total score ranging from 15 to 60 with higher scores indicate stronger empathy abilities.
Socio-emotional competencies: Self-reported, Self-Efficacy Questionnaire for Youth
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised self-reported Self-Efficacy Questionnaire for Youth. This brief questionnaire is designed to assess self-efficacy in youths. It consists of 10 items, each rated on a 5-point Likert scale. The Self-Efficacy Questionnaire for Youth gives a total score that range from 10 to 50, with higher scores reflecting better perceived self-efficacy.
Socio-emotional competencies: Parent-reported, Strength and Difficulty Questionnaire (SDQ)
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Strength and Difficulty Questionnaire (SDQ). The SDQ is a well-validated 25-item questionnaire designed to assess behavioural problems in children and adolescents aged 4 to 16. It consists of: a) four subscales, emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems (min=0, max=10) with higher scores indicate more difficulties, b) an additional prosocial behavior subscale with higher scores indicate better outcomes in prosocial behavior, and c) a total difficulties score, based on emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems, is also measured with higher scores reflecting greater behavioral difficulties (min=0, max=40).
Socio-emotional competencies: Parent-reported, Behaviour Rating Inventory of Executive Function (BRIEF)
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Behaviour Rating Inventory of Executive Function (BRIEF), Behavioural Regulation Scale. The Behavioural Regulation Scale from the BRIEF consists of 16 items designed to evaluate a child's ability to control their behaviour and emotions, such as impulse control, emotional regulation, and the capacity to shift between tasks or thoughts. The Behavioural Regulation Scale is typically reported as T-scores (M=50, SD=10) with higher scores reflect more executive difficulties.
Socio-emotional competencies: Parent-reported, Social Skills Improvement System (SSIS)
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Socio-emotional competencies will be evaluated in young adolescents using the standardised parent-reported Social Skills Improvement System (SSIS), Social Skills Scale. The Social Skills Scale from the SSIS consists of 46 items, each rated to reflect the frequency and quality of specific social behaviours in different contexts. It is designed to assess a range of social behaviours that contribute to positive interactions and relationships. This scale evaluates various domains, including communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. The instrument yields norm-referenced scores for the Social Skills Scale (M = 100, SD = 15) with higher scores reflecting better social competence and more positive social interactions.
Well-being: Self-reported, KIDSCREEN-27
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Well-being will be evaluated in young adolescents using the standardised self-reported KIDSCREEN-27 questionnaire. The KIDSCREEN-27 contains 27 items, with responses capturing the frequency or intensity of experiences related to the child's health and well-being over the past week. It is designed to measure health-related quality of life and it assesses five dimensions: Physical Well-being, Psychological Well-being, Autonomy \& Parent Relations, Social Support \& Peers, and School Environment. For each dimension, scores are typically transformed to a continuous scale ranging from 0 to 100, with higher scores reflecting better outcomes.
Well-being: Parent-reported, KIDSCREEN-27
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Well-being will be evaluated in young adolescents using the standardised parent-reported KIDSCREEN-27 questionnaire. The KIDSCREEN-27 contains 27 items, with responses capturing the frequency or intensity of experiences related to the child's health and well-being over the past week. It is designed to measure health-related quality of life and it assesses five dimensions: Physical Well-being, Psychological Well-being, Autonomy \& Parent Relations, Social Support \& Peers, and School Environment. For each dimension, scores are typically transformed to a continuous scale ranging from 0 to 100, with higher scores reflecting better outcomes.
Push-up measurement
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Push-up (total number of repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Sit-Up/Curl-Up test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Sit-Up/Curl-Up Test (total number of repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Sit and Reach test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Sit and Reach Test (in cm) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Run in Place test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Run in Place for 90 seconds (record number of heart rate in 30 seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
One foot balance test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
One foot balance (in seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Basic paper ball bounce test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Basic paper ball bounce test (bounce the ball at least three times with each hand) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Left-right paper ball bounce test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Bounce the ball back and forth between the right and left hands (maximum number of bouncing) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Shuttle Run test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Shuttle Run test (9 meters side move repetitions - number of times/repetitions) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Dash test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
50 meters Dash test (in seconds) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Standing Broad Jump test
Time frame: Pre-intervention (baseline) and 16 weeks post-intervention
Standing Broad Jump (in cm) will be assessed by PE teachers. This measurement is part of the general physical fitness assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 27064552Spruit A, Assink M, van Vugt E, van der Put C, Stams GJ. The effects of physical activity interventions on psychosocial outcomes in adolescents: A meta-analytic review. Clin Psychol Rev. 2016 Apr;45:56-71. doi: 10.1016/j.cpr.2016.03.006. Epub 2016 Apr 3.
- Background: PubMed 31760378Choden U, Sherab K, Howard J. Experience of bullying among Bhutanese college students: implications for teacher formation programmes. Int J Adolesc Med Health. 2019 Nov 25;34(1). doi: 10.1515/ijamh-2019-0087.
- Background: PubMed 27542849Lubans D, Richards J, Hillman C, Faulkner G, Beauchamp M, Nilsson M, Kelly P, Smith J, Raine L, Biddle S. Physical Activity for Cognitive and Mental Health in Youth: A Systematic Review of Mechanisms. Pediatrics. 2016 Sep;138(3):e20161642. doi: 10.1542/peds.2016-1642. Epub 2016 Aug 19.
- Individual participant dataSharing planned: No. Data will be available to researchers who provide a proposal that supports the aims of the approved study. Proposals should be submitted to kezangsherab.pce@rub.edu.bt
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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.
Kezang Sherab, PhD principal investigator
Paro College of Education & Royal Thimphu College, Bhutan
Vanessa Siffredi, PhD principal investigator
Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced physical education and HPE Standard curriculum in people with School-based Intervention, run by Centre Hospitalier Universitaire Vaudois at 1 site in Bhutan.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bhutan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Siffredi, PhD (+41795781056, vanessa.siffredi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-emotional competencies: Self-reported, Strength and Difficulty Questionnaire (SDQ) (time frame: Pre-intervention (baseline) and 16 weeks post-intervention). The study lists 19 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 NCT06820632, 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 11 Feb 2025.