Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT07906522

Future School of Comprehensive Well-Being

Sponsor: University of Helsinki

View on ClinicalTrials.gov

Summary

Good physical, mental and social health, particularly in childhood and early adolescence, are powerful predictors of positive life trajectories. Contrary to this, problems in these domains expose individuals to negative developmental trajectories. Schools are ideal settings to address these issues due to their incisiveness and long-term impact. However, school-based well-being interventions are not designed to be ingrained in basic pedagogical processes of school, this is, learning, teaching and studying. In this study the effects of a school-based pedagogically ingrained comprehensive well-being trial will be studied, involving curriculum embedded socio-pedagogical activities, designed to cultivate simultaneously learning and their mental, social and physical well-being. In the Future School of Comprehensive Well-Being (SchoolWell) Comprehensive wellbeing pedagogy intervention for primary and lower secondary school students: rationale and study protocol for the SchoolWell cluster randomized controlled trial -study the investigators use a cluster randomized hybrid type 1 effectiveness-implementation design. SchoolWell involves 10 Finnish speaking Teacher Training Schools including both primary and secondary schools. Randomization occurs at the school level. The intervention is a multicomponent implementation strategy that has been co-designed by SchoolWell research team and case schools' teachers. All 5th and 8th graders (aged 11-12 years and 14-15 years), from the control and intervention schools are eligible for the study. Total of 1440 students (560 5th and 880 8th graders) will be recruited for the study (n=717 students from intervention schools and n=723 students from control schools). Data is collected from Grade 5 and 8 students representing schools randomized to experimental (n=5) and control condition (n=5). The control group in Year 1 remains on the waitlist until the start of Year 2, when the second cohort of the experiment (low support condition) for these schools begins. The purpose of the low support condition is to examine whether intervention effects can be achieved with less support than in the high support condition, where researchers are more actively involved. Schools allocated to the intervention group deliver weekly SchoolWell activities over the full school year as part of the regular curriculum. The activities include socio-pedagogical activities, these are modes of teaching, learning and studying, promoting student mental, social and physical well-being as well as learning aligned with regular curriculum goals. Intervention schools have access to six implementation support strategies in addition to the training received as usual delivery to build knowledge and skills. Implementation and effectiveness outcomes are assessed using weekly online surveys, interviews at baseline T0 (8/2024), T1 (11/2024), T2 (4/2025) and at 19-month follow-up (T3; 4/2026) and four dialogues with teachers. Semi-structured interviews with teachers and support staff will be used to examine which implementation strategies worked for whom and under what conditions. The primary outcome is study engagement. Secondary outcomes include measures on learning, mental, social and physical well-being. Economic and process evaluations will also be conducted to determine cost-effectiveness, program acceptability, implementation, adaptability, and sustainability in schools. SchoolWell draws on the Consolidated Standards of Reporting Trials (CONSORT) and the Standards for Reporting Implementation Studies (StaRI) in evaluating the SchoolWell intervention. Also, the Consolidated Framework for Implementation Research (CFIR) is used to guide support strategies. The CFIR provides constructs that have been associated with effective implementation (intervention, outer settings, inner settings, individuals, implementation process). Subsequently, the Proctor's framework is followed to evaluate the implementation process. The framework stands for acceptability (treatment is agreeable or satisfactory), adoption (intention to employ an innovation or evidence-based practice), appropriateness (fit of the innovation to address a particular issue or problem), cost (cost impact of an implementation effort), feasibility (extent to which a new treatment can be successfully carried out in given setting), fidelity (extent how intervention is delivered as intended), penetration (number of providers who deliver treatment), and sustainability (extent to which a newly implemented treatment is maintained). Hypotheses are: H1. SchoolWell 1 intervention will have a positive effect on student-level outcomes (8- and 19-month post-tests). H2. The multidisciplinary intervention enhances both learning and mental, physical, and social well-being.

Official title: Future School of Comprehensive Well-Being (SchoolWell) Comprehensive Well-being Pedagogy Intervention for Primary and Lower Secondary School Students: Rationale and Study Protocol for the SchoolWell Cluster Randomized Controlled Trial

Key Details

Gender

All

Age Range

11 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

1440

Start Date

2024-08-01

Completion Date

2028-09-30

Last Updated

2026-10-30

Healthy Volunteers

Yes

Conditions

Learning Comprehensive Wellbeing Social Wellbeing Physical Wellbeing Mental Wellbeing Pedagogical Practices General Mental Health and Well-Being Mental Disorders Common Mental Disorders (CMD)Sedentary Behavior Physical Inactivity Depressive Symptom Anxiety Resilience, Psychological

Interventions

BEHAVIORAL

Comprehensive well-being pedagogy intervention for primary and lower secondary school students

The Comprehensive well-being pedagogy intervention for primary and lower secondary school students includes 6 core components to contribute to students' school engagement through developing their comprehensive well-being. The intervention is implemented in 2 phases: 1) co-creation process with the teachers and 2) intervention in the classrooms during one whole academic year. The co-creation process includes 4 meetings during the first year of the trial and the contents of the intervention are adapted according to the information obtained with these meetings. The intervention includes an online platform with a library of activities and practices for the teacher to implement in classrooms as part of normal schoolwork. These activities include learning skill exercises, cooperative and activity-based learning methods, movement-integrated classroom breaks, physical functioning enhancement activities during physical education, social interaction training, and mindfulness-based exercises.

All Finnish speaking teacher training schools (n=10) in Finland, located in different parts of the country are recruited to the study. The teacher training schools organize the teaching practice included in the pedagogical studies required of teachers as part of the University's teacher education in a teacher training school. They organize and supervise the teaching practice and develop it. The teacher training schools draw up the school-specific teaching practice plans to meet the University's degree requirements. Both teacher training schools are education providers as defined in the Basic Education Act and the General Upper Secondary Schools Act. The teacher training schools collaborate with other departments in the Faculty of Educational Sciences, other University units and national and international education organizations in research, continuing education and instruction. Teacher training schools were recruited due to their role in teacher education, this is, their practices having impact on teacher education, and the fact we were able to recruit all Finnish teacher training schools to take part of our study. In Finland, qualified primary and lower secondary teachers must have university MA degree. Class teachers (teaching grades 1-6) major either in educational sciences or in educational psychology while subject teachers teaching at the graders 7-9 major in certain subjects such as math, mother's tongue or physical education, and have completed additional one-year pedagogical studies. All the 5th and 8th grade classes from the teacher training schools were considered eligible for the study. The 5th grade class teachers and 8th grade core subject teachers (math, Finnish and physical education teachers) are invited to take part of SchoolWell intervention. Inclusion Criteria: * Finnish speaking teacher training school in Finland * 5th grade * or 8th grade (math, Finnish and physical education lessons) Exclusion Criteria: * schools other than training schools * other grades than 5th and 8th

Locations (6)

University of Helsinki

Helsinki, Finland

University of Eastern Finland

Joensuu, Finland

Jamk University of Applied Sciences

Jyväskylä, Finland

University of Jyväskylä

Jyväskylä, Finland

University of Oulu

Oulu, Finland

Tampere University

Tampere, Finland