NCT05407623 A Cluster-randomized Control Trial of PAX Good Behavior Game in Swedish Elementary Schools
| NCT ID | NCT05407623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linnaeus University |
| Condition | Well-being in Elementary School Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,184 participants |
| Start Date | 2021-04-21 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,184 participants in total. It began in 2021-04-21 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
ON SCHOOL LEVEL: Inclusion Criteria: * The school uses the general study plan (i.e. the school is not only working with students with special needs) * There is at least one teacher that is willing to participate, signs the study consent, and will be able to start the implementation in his/her class at the earliest in the second semester in the first grade or at the latest the first semester in the third grade. * The principal has signed an agreement to participate in the project, to allow some time for measurements to be administrated, aid in delivering information to the parents, and that the school are responsible for implementing the methods within their regular operation (given that supervision is provided by the research team) Exclusion Criteria: * Another method that specifically aims to improve study and classroom environment is being implemented * Another method that is expected to be time and energy consuming for teachers is being implemented during the same period ON TEACHER LEVEL: Inclusion criteria: * The teacher mentors a class of 1st or 2nd graders following the general study plan (ready to implement the program no later than the first semester of the 3rd grade) and deems the class suitable for inclusion in the study * The teacher has signed the informed consent Exclusion criteria: * The teacher has expressed plans to terminate their employment during the upcoming two years * A major change in the composition of the class is planned during the upcoming year.
Contact & Investigator
Viktor Kaldo, PhD
PRINCIPAL INVESTIGATOR
Linnaeus University
Frequently Asked Questions
Who can join the NCT05407623 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 10 Years, studying Well-being in Elementary School Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05407623 currently recruiting?
Yes, NCT05407623 is actively recruiting participants. Contact the research team at viktor.kaldo@lnu.se for enrollment information.
Where is the NCT05407623 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05407623 clinical trial?
NCT05407623 is sponsored by Linnaeus University. The principal investigator is Viktor Kaldo, PhD at Linnaeus University. The trial plans to enroll 2,184 participants.