PAX Good Behavior Game - A Cluster-randomized Controlled Evaluation and Qualitative Analysis of Effects on Work Environment, Learning, Mental Health and Health Economic Aspects of Implementing a Classroom-based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,184
- 试验地点
- 1
- 主要终点
- [Teacher-focused] Teacher Stress Inventory (TSI) (an 8 items subscale).
研究概览
简要总结
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.
详细描述
Design
A cluster-randomized controlled trial will be conducted randomizing approximately 28 schools (clusters) with a total of 84 teachers/classrooms into either receiving training and supervision in PAX GBG or receiving equally much training and supervision for implementing one of the control interventions.
Teachers in both arms will be implementing and using the intervention they were randomized to during the first year and then start implementing also the other intervention, while continuing using the first. When the baseline measure occurs at the end of grade 2 and the initial intervention is implemented for pupils during grade 3, the pupils in these classes will only receive one intervention since they move up to middle school where none of the methods are used. The teacher will instead start over with new pupils in grade 1 and use both methods with them. The sub-group of pupils that receives only one intervention will thus preserve the randomized controlled design also for long-term follow-ups.
Procedure
Ideally, half of the classrooms will be enrolled to start the intervention/control intervention during the spring semester and half during the autumn semester. The purpose of this is to control for the occasional effect of the point in time during the school year, and calendar year, when the intervention is introduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
[Teacher-focused] Teacher Stress Inventory (TSI) (an 8 items subscale).
时间窗: Up to 24 months. See Detailed Description section for the details of the measurement points.
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.
[Pupil-focused] KIDSCREEN-10 extended with 3 items
时间窗: Up to 24 months. See Detailed Description section for the details of the measurement points.
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.
[Pupil-focused] KIDSCREEN-10 extended Teacher-rated
时间窗: Up to 24 months. See Detailed Description section for the details of the measurement points.
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.
[Classroom-focused] Frequency of on-task/off-task behaviors occurring in the classroom during an observation by a research assistant.
时间窗: Up to 24 months. See Detailed Description section for the details of the measurement points.
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.
次要结局
- [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.)
- [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] 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] The parents' need to stay home from work in order to take care of a sick child(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.)
- [Pupil-focused] Number of primary health contacts(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.)
- [Pupil-focused] Neurodevelopmental diagnoses(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.)
- [Pupil-focused] Heidelberger-Rechen Test 4 dimensions (HRT-4)(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Teacher Stress Inventory (TSI) (a 12 items subscale).(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Work Ability Score-1(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Consumption of prescription drugs(Total consumption of prescription drugs between the pre-measure and primary end-point 2 school semesters after the start of the implementation. Long-term follow-up measures after 4 semesters)
- [Teacher-focused] Stress, demands and influence - 4 items(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Pupil-focused] LegiLexi(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] The 7-item Stress subscale from the Depression, Anxiety ans Stress Scale (DASS)(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Self-Rated Health-1(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Treatment Inventory for Costs in Psychiatric Patients (TIC-P)(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Copenhagen Psychosocial Questionnaire Version III (COPSOQ-III)(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Eighteen items from The Teaching and Learning International Survey (TALIS)(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Teacher Self-Efficacy Scale (TSES)(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Additional questions on the teachers' attitudes towards the profession and their inclination to continue working as teachers(At baseline, then after 6, 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Single Item Stress(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Insomnia Severity Index (ISI)(At baseline, then after 6, 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] General Health Questionnaire - 12 items (GHQ-12)(At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.)
- [Teacher-focused] Data on short-term sick-leaves(Total sick-leaves between the pre-measure and primary end-point 12 months after the start of the implementation. Long-term follow-up measures after 24 months.)
- [Teacher-focused] Health care consumption(Total health care consumption between the pre-measure and primary end-point 2 school semesters after the start of the implementation. Long-term follow-up measures after 4 semesters)
- [Classroom-focused] Noise-levels in the classroom(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Implementation measure] Teachers' fidelity to the intervention - self-rated(The instrument will be filled out prior to the supervision sessions 1-6 (see Design -> Interventions for the time-frames).)
- [Implementation measure] The rate of use of PAX-tools: teacher self-rated(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Implementation measure] Six questions on the use of the PAX-game (only intervention arm): teacher-rated(At M3 through M6 (see Design section for the description of the measurement points).)
- [Implementation measure] Six questions on the use of Count on Me! (only Count on Me!-arm): teacher-rated(Starting at 3-4 months after baseline and up to 24 months (see Design section for the description of the measurement points).)
- [Classroom-focused] Frequency of disruptive behaviors, positive/negative interactions and time for transition from one task to another occurring in the classroom during an observation by a research assistant.(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Implementation measure] The Normalisation MeAsure Development questionnaire - Swedish version (S-NOMAD)(3-4, 6, 12 and 24 months after the baseline. See Detailed Description section for the details of the measurement points.)
- [Implementation measure] Teachers' fidelity to the intervention - observer-rated(The observations will be conducted prior to the supervision sessions 1-6 (see Design -> Interventions for the time-frames).)
- [Implementation measure] Pupils' attitudes towards and acceptability of the method(8-9, 12 and 24 months after the baseline. See Detailed Description section for the details of the measurement)
- [Implementation measure] The rate of use of PAX-tools: observer-rated(Up to 24 months. See Detailed Description section for the details of the measurement points.)
- [Implementation measure] Social validity of PAX/control: teacher-rated(Starting at 3-4 months after baseline and up to 24 months (see Design section for the description of the measurement points).)
- [Implementation measure] Positive and negative effects of PAX/control: teacher-rated(8-9, 12 and 24 months after the baseline. See Detailed Description section for the details of the measurement)
- [Implementation measure] Social validity of PAX/control: pupil-rated(Starting at 3-4 months after baseline and up to 24 months (see Design section for the description of the measurement points).)
- [Implementation measure] Social validity of PAX/control: pupil-focused teacher-rated(Starting at 3-4 months after baseline and up to 24 months (see Design section for the description of the measurement points).)
- [Negative effects] Questions on negative effects of PAX/control: teacher-reported(Starting at 3-4 months after baseline and up to 24 months (see Design section for the description of the measurement points).)
- [Implementation measure] Training assessment (PAX/control): teacher-rated(Right after the training as well as 12 and 24 months after baseline (see Design section for the description of the measurement points).)
研究者
Viktor Kaldo
Professor
Linnaeus University