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A Cluster-randomized Control Trial of PAX Good Behavior Game in Swedish Elementary Schools

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 11, 2025 (before its estimated June 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Dec 15, 2025 to Jun 15, 2026
    • Study completion date: Dec 15, 2026 to Jun 15, 2027
    v3
  2. Notable Primary completion date: Dec 15, 2023 to Dec 15, 2025
    • Study completion date: Dec 15, 2024 to Dec 15, 2026
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Two important challenges that primary school in Sweden is confronted by are increasing levels of mental illness among children and adolescents and increasing rates of stress related symptoms and sick leave associated with mental illness in primary school teachers. Primary school is an important arena to address these issues. PAX is implemented as a part of the regular classroom activities and gives the teacher tools to promote behaviors that are constructive and learning oriented. The programme has been shown to improve student health and performance both short- and long-term. The teachers also receive tools to lessen stressors in their working environment. A Swedish uncontrolled pilot study showed increased well-being in children and reduced teacher stress as well as improved work related well-being at post-intervention. The aim of this project is to study the effects of PAX on student well-being and teacher stress. In a cluster-randomized design, 84 teachers from 28 schools (clusters) will be randomized to either implement PAX, or to an active control group that receives the same amount of support but with different content. The PAX group will get a two-day education in PAX at the start of the term, followed by an implementation-term. The measurements include self-assessment, blind observer assessments, objectively measuring sound levels, data on sick leave and qualitative interviews. Baseline measurements are performed before implementation and primary end point is one year after. Costs and savings related to PAX will be measured and put in relation to the quality-adjusted life years of students and teachers. Long-term effects on student performance, health and participation in society will be evaluated in a follow-up project.
Trial Details
NCT Number NCT05407623
Lead Sponsor Linnaeus University
Collaborators: Stockholm University, Karolinska Institutet, Uppsala University, KTH Royal Institute of Technology, Vestigio (NGO)
Conditions
(from sponsor)
Well-being in Elementary School Children, Mental Health in Elementary School Children, Work-related Stress in Teachers, Academic Performance in Elementary School Children
Related terms Occupational Stress, Psychological Well-Being
Enrollment 2,184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov