NCT05407623

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,184

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress82%
Apr 2021Jun 2027

Study Start

First participant enrolled

April 21, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

5.2 years

First QC Date

April 23, 2021

Last Update Submit

April 8, 2025

Conditions

Keywords

PreventionPedagogyPsychologyLeadershipPedagogical leadershipLearningWork-related stressMental healthWork environmentSchool-based researchQualitative reserachQuantitative researchGood classroom environmentMath skills

Outcome Measures

Primary Outcomes (4)

  • [Pupil-focused] KIDSCREEN-10 extended with 3 items

    The 10-items questionnaire for assessing children and adolescents health and well-being KIDSCREEN-10 and 7 additional items from the full KIDSCREEN-52 (self-assessment versions). A selection of 13 of these items will be summarized and used as the primary outcome on pupil level. The scores of the extended scale range between 13 and 65 with a higher score indicating higher level of health and well-being.

    Up to 24 months. See Detailed Description section for the details of the measurement points.

  • [Pupil-focused] KIDSCREEN-10 extended Teacher-rated

    N=13 items from KIDSCREEN-10 and KIDSCREEN-52 for assessing children and adolescents health and well-being (Parent versions completed by the teachers), corresponding to the 13 items rated by the pupils as the primary outcome measure. The items are selected based on relevance in the school context. The scores of the extended scale range between 13 and 65 with a higher score indicating higher level of health and well-being.

    Up to 24 months. See Detailed Description section for the details of the measurement points.

  • [Teacher-focused] Teacher Stress Inventory (TSI) (an 8 items subscale).

    TSI is a self assessment instrument measuring work-related stress in teachers. The subscale Discipline and motivation (8 items in total) will be used as the primary outcome measure. The total score of the subscale ranges between 8 and 40 with higher scores indicating more severe work-related stress in teachers.

    Up to 24 months. See Detailed Description section for the details of the measurement points.

  • [Classroom-focused] Frequency of on-task/off-task behaviors occurring in the classroom during an observation by a research assistant.

    Classroom-observations by a trained observer will be conducted during two or three lessons during the same or conceding days, for a minimum time of 20 minutes for each class according to a standardized observational schedule. Actual frequencies of on-task/off-task behaviors in the classroom, unrelated to the person performing the behavior, will be counted.

    Up to 24 months. See Detailed Description section for the details of the measurement points.

Secondary Outcomes (42)

  • [Pupil-focused] Child Health Utilities - 9 dimensions (CHU9D)

    At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.

  • [Pupil-focused] KIDSCREEN-10

    At baseline, then after 6, 12 and 24 months. See Detailed Description section for the details of the measurement points.

  • [Pupil-focused, administered by the teacher] Strengths and Difficulties Questionnaire (SDQ) [the 5-items dysregulation profile]

    Up to 24 months. See Detailed Description section for the details of the measurement points.

  • [Pupil-focused, administered by the teacher] Strengths and Difficulties Questionnaire (SDQ) [the 15-items dysregulation profile]

    At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.

  • [Pupil-focused] School absence

    A total measure for comparison between the randomization groups 12 months after baseline, and for comparison to a matched control group 24 months after baseline.

  • +37 more secondary outcomes

Study Arms (2)

PAX Good Behavior Game

EXPERIMENTAL

PAX Good Behavior Game (GBG) is based on its precursor programme Good Behavior Game (GBG) that trains teachers to use principles of social learning in order to maximize the childrens' task-oriented and prosocial behaviors and minimize the occurrence of disruptive and off-task behaviors.

Behavioral: PAX Good Behavior Game

Active control (choice between on of two active interventions)

ACTIVE COMPARATOR

\[The project has two alternative control interventions for the schools to choose between, in order to increase their engagement in the control intervention. They are hence only provided with one of these interventions, not both.\] Count On Me! is an adaptive application teaching fluency in addition and subtraction facts (i.e., math facts), equality, compose and decompose numbers and a few more basic mathematical skills taught in the first grades of schooling. Collegial earning is based on five cyclical steps for professional learning for teachers.

Behavioral: Count on Me!Behavioral: Collegial Learning Community

Interventions

PAX GBG is packaged into ten specific tools that the teachers are trained to introduce in in their classroom management practice. The program introduces verbal and visual cues that facilitate prosocial and attentive behaviors One of the core elements of the program is the PAX-game, meaning that the children - while focusing on ordinary school tasks like math - get to play a game in teams where each team tries to make as few classroom rules infractions as possible during a certain period of time. The teams that succeed in achieving predetermined goals get a reward (often a fun and desirable activity) that serves as a reinforcer of prosocial and task-oriented behaviors. Supervision is performed individually with each teacher and included that the PAX-trainer observes a lecture given by the teacher before each supervision session.

PAX Good Behavior Game
Count on Me!BEHAVIORAL

Count on me! is set in adventure game where the child has an avatar that travels thru different worlds/platforms by using their mathematical skills. The child starts of in the home of the avatar, in a house like environment, where the child discovers a magical map that brings the child into a different world called Numberia. During the adventures in Numberia the child learns that it has certain skills, called the mathemagical powers, that will be used to liberate Numberia from the evil Prince Claw that has captured all the beautiful things (e.g., the birds that used to sing in the forest). Count on me! was developed within a behavior analytic framework using a nonlinear programming process.

Active control (choice between on of two active interventions)

Collegial learning community is a feasible way of professional learning for teachers according to the five cyclical steps. The teachers go through the first step that is to assess the skill or knowledge gaps for students, using various data sources (for example testing, grades, surveys, student interviews). The second step is to reflect upon what skills the teacher needs to acquire in order to help the students to meet the goals. The third step is to deepen the professional knowledge and skills. The fourth step is engaging the students in the new practice, and in the fifth step to evaluate the impact the new practice has had on student outcomes. In Collegial learning community teachers take help from their peers in each of these steps in a structured way. For example, way of deepening tacit or procedural knowledge (in step two) is to visit a colleague during class and make observations on their classroom practice.

Active control (choice between on of two active interventions)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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:
  • The teacher has signed the informed consent
  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Several Schools in Sweden will be recruited, although as participants and not independent sites

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Occupational StressPsychological Well-Being

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Viktor Kaldo, PhD

    Linnaeus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktor Kaldo, PhD

CONTACT

Ekaterina Ivanova, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2021

First Posted

June 7, 2022

Study Start

April 21, 2021

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2027

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations