NCT06820632

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

January 29, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

physical educationadolescencesocio-emotional competencieswell-beingbhutan

Outcome Measures

Primary Outcomes (19)

  • 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).

    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.

    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.

    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.

    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).

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Pre-intervention (baseline) and 16 weeks post-intervention

Study Arms (3)

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.

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.

Behavioral: HPE Standard curriculum

Control school

NO INTERVENTION

A school without physical education classes

Interventions

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.

Enhanced physical education

Health and physical education (HPE) standard curriculum includes roughly one hour per week of general physical education, typically involving activities like football and basketball.

Health and Physical Education (HPE) standard curriculum

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to participate in physical education courses: Students unable to participate in physical education classes due to medical or other significant reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paro College of Education, Bhutan

Paro, Paro Dzongkhag, CC8C+FV2, Bhutan

Location

Related Publications (3)

  • 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.

    PMID: 27064552BACKGROUND
  • Choden 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.

    PMID: 31760378BACKGROUND
  • Lubans 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.

    PMID: 27542849BACKGROUND

Study Officials

  • Kezang Sherab, PhD

    Paro College of Education & Royal Thimphu College, Bhutan

    PRINCIPAL INVESTIGATOR
  • Vanessa Siffredi, PhD

    Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Siffredi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 11, 2025

Study Start

February 10, 2025

Primary Completion

July 31, 2025

Study Completion

August 31, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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

Locations