An interventional study of Comprehensive well-being pedagogy intervention for primary and lower secondary school students in Learning, Comprehensive Wellbeing and Social Wellbeing, sponsored by University of Helsinki. Active, not recruiting at 6 sites in Finland. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Helsinki · Not applicable, Interventional, and Prevention
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.
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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:
Exclusion Criteria:
Teachers and students in the participating schools in this arm were offered a co-created multimodal intervention to promote learning and comprehensive well-being in schools. This arm got high support to implement the intervention.
Behavioral: Comprehensive well-being pedagogy intervention for primary and lower secondary school students
This arm acts as a control group for the intervention arms. Arm does not get the intervention, but the same measurements are applied as in intervention schools.
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.
Also known as: SchoolWell intervention
Study engagement
Study engagement scale (9 items), which measures energy, dedication, and absorption in studying. Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher value indicating stronger engagement.
Time frame: up to 19 months
Resilience
Connor-Davidson Resilience Scale (CD-RISC, 10 items). Comprises 25 items, each rated on a 5-point scale (0-4). Range from 0 to 100, with higher scores reflecting greater resilience.
Time frame: up to 19 months
Anxiety and depression
Anxiety and depressive symptoms; Revised Child Anxiety and Depression Scale (RCADS, 25 items). The RCADS-25 has 25 items, each rated on a 4-point Likert scale (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always). Therefore, the total raw score can range from 0 to 75 (25 items × 3 points each). Higher scores indicate more symptoms of anxiety or depression.
Time frame: up to 19 months
Generic well-being
The World Health Organization-Five Well-Being Index (WHO-5) (5 items). Each item is rated on a 6-point Likert scale. The total raw score range is 0-25; higher scores indicate better well-being.
Time frame: up to 19 months
Study burnout
Study burnout scale (7 items). Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher scores reflecting higher risk for study burnout.
Time frame: up to 19 months
Social media addiction
Bergen Social Media Addiction Scale (BSMAS, 6 items)
Time frame: up to 19 months
Classroom peer interaction
The Classroom Peer Context Questionnaire (CPCQ, 20 items). Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher value indicating better fit and atmosphere.
Time frame: up to 19 months
Peer social support
Peer support scale (10 items). Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher scores reflecting greater peer support for studying.
Time frame: up to 19 months
Empathy towards peers
Empathy towards peers scale (9 items)
Time frame: up to 19 months
Teacher social support
Teacher support scale (11 items). Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher scores reflecting greater teacher support.
Time frame: up to 19 months
Guardian support for studying
Guardian support scale (7 items). Each item is rated on 5-point scale assessing frequency (1 = never, 2 = rarely, 3 = sometimes, 4 = quite often, 5 = very often), with higher scores reflecting more frequent guardian support.
Time frame: up to 19 months
Cardiorespiratory fitness
The 20 m shuttle run test. Participants are required to run continuously between two lines set at a distance of 20 m, keeping cadence with a recording (beeps) that increases in pace as the test progresses. The total number of shuttles (laps) achieved while keeping to pace is recorded.
Time frame: up to 19 months
Abdominal strength/endurance
The curl-up test. Participants are required to lie on their back, keep heels on mat, and slowly curl up, while curling up sliding fingertips across a measuring tape until reaching the other side, and then curl back down until their head touches the mat. The length of the measuring tape is 8 cm at grade 5 and 12 cm at grade 8. Performance cadence is guided by a recording. The total number of curl-ups (min, 0; max, 75) completed correctly while keeping in time with the cadence recording is recorded.
Time frame: up to 19 months
Upper body strength/endurance
The push-up test. The test has different protocols for boys and girls. The boy's starting position requires hands and toes to be on the floor, whereas the girl's starting position requires hands and knees on the floor. All other steps for the test are the same for both sexes: head, body, and legs are in a straight line; feet together; arms shoulder-width apart; body lowered until there is a 90° angle in elbows; upper arm parallel to the floor; and back and knees straight while pushing up, until the arms are straight. The total number of correctly completed push-ups in 60 s is recorded.
Time frame: up to 19 months
Flexibility
A composite score comprising four measurements (squat, lower back extension and left and right shoulder stretch) assessing multi-joint flexibility. The maximum score in flexibility is 4 and minimum 0. Squat: squatting as low as one can while keeping his/her back extended, arms raised straight up, knees behind the toe line, hip angle above 45°, heels on the ground, and feet and knees shoulder-width apart. A result of 1 is recorded if participant reaches a knee angle ≤ 90° and 0 if the knee angle is \> 90° and/or participant cannot keep the proper position. Lower back extension in sitting posture: Results are marked as 1 if participant's lower back is extended and as 0 if the lower back is not extended and/or participant cannot keep the proper position. Shoulder stretch: Results are marked as 1 if participant can reach his/her fingers together between shoulder blades and as 0 when participant cannot reach his/her fingers together and/or participant cannot keep the proper position.
Time frame: up to 19 months
Object control skills
The throw-catch test. A target square (1.5 m × 1.5 m) is marked on a wall at 90 cm above floor level. Throwing distance depends on the participant's grade and sex (7 and 8 m at grade 5, and 8 and 10 m at grade 8, respectively, for girls and boys). Participants are instructed to throw a tennis ball with their preferred hand directly at the target and to catch the ball after one bounce with one or both hands. Participants are allowed 20 trials, and the result is the number of successfully completed trials (i.e., the ball hit the target and was caught after one bounce).
Time frame: up to 19 months
Locomotor skills and lower body strength
The 5-leaps test. The 5-leaps test consists of five consecutive strides with feet together at the start and end of the five leaps sequence. Participants are allowed to start the strides with their desired leg. The test is performed twice, and the better result (that is, the overall distance covered in meters rounded to two decimal places) is recorded.
Time frame: up to 19 months
Perceived health
One item "What do you think about your current health?" The item is rated on a five-point Likert scale (1= very good…5 = very bad).
Time frame: up to 19 months
Perceived physical competence
The Finnish version of the sport competence dimension of the Physical Self Perception Profile (PSPP). Each item is preceded by the stem:" What am I like?" and all five items of the PSPP are rated on a five-point scale (e.g., 1 = I'm among the best when it comes to athletic ability … 5 = I'm not among the best when it comes to athletic ability).
Time frame: up to 19 months
Grade 5 students' physical activity and sedentary behavior
Hip-worn accelerometers (ActiGraph GT3X+, wGT3X+, Pensacola, Florida, USA) during waking hours for 7 consecutive days. Participants are instructed to always wear the device on their right hip during their waking hours, except while bathing or doing water-based activities. Data are collected as raw accelerations at a frequency of 30 Hz and converted into 15-s epoch counts. Customized Visual Basic Macro for Excel software is used for data reduction. A valid day of physical activity monitoring includes measured values ≥600 min/day for at least two weekdays and one weekend day between general waking hours (i.e., 7 am and 11 pm). Periods of 30 min of consecutive zero counts are defined as non-wear time, and values over 20 000 counts per minute (cpm) are considered spurious accelerations and discarded. Cut points are used to calculate MVPA (≥2296 cpm).
Time frame: up to 19 months
Grade 8 students' physical activity and sedentary behavior
Grade 8 students' physical activity and sedentary time is measured using a thigh-worn accelerometer (Axivity AX3, York, United Kingdom) 24-hour a day for 7 consecutive days. Data are collected in raw 100 Hz acceleration with range 8 g. ActiPASS (version 1.62) is used for data reduction and analyses. The valid amount of data is set at ≥10 hours/d, including at least 2 weekdays and 1 weekend day.
Time frame: up to 19 months
Self-reported physical activity
A two-item self-report scale. The stem for the items is: 'In the next two questions physical activity means all activities which raise your heart rate or momentarily gets you out of breath for example in doing exercise, playing with your friends, going to school, or in school physical education. Physical activity also includes for example jogging, intensive walking, roller skating, cycling, dancing, skating, skiing, soccer, basketball, and baseball.' The items are: 'Think about your typical week. How many days did you exercise for at least 60 min. during which you got out of breath' and 'Think about your last 7 days. How many days did you exercise for at least 60 min. during which you got out of breath?'. Both items are presented using an eight-point response scale (0 to 7 days in a week). A sum-scale of physical activity is computed by calculating a mean score for the two items.
Time frame: up to 19 months
Collective learning agency
Collective learning agency; Collective learning agency scale (13 items). Each item is rated on 7-point Likert scale (Totally disagree = 1, Totally agree =7), with higher scores reflecting greater collective learning agency.
Time frame: up to 19 months
School achievement
Grade Point Average (GPA) and grades in each school subject and in behavior.
Time frame: up to 19 months
Plan to share: Yes — All personal data and recoded data collected in the SchoolWell project will be stored securely (services provided by the Finnish Information Technology Centre, CSC) for a max. of 25 years. The data is intended to be used to investigate the project's research questions in follow-up studies, and the need for data retention and secure storage will be assessed every 5 years. After the deadline has expired, the anonymized survey data collected in the project will be handed over and archived for further use in the Social Science Data Archive https://www.fsd.tuni.fi. A metadata description will be prepared for the data collected in the project and stored after the project ends on the Etsin platform. This includes a description of the research implementation, the data collection instrument, such as surveys or interview protocols, a description of the files and variables used, paradata and availability information. In addition, instructions for data collectors and processors will be stored.
Supporting information: Study protocol, Informed consent form
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