A Cluster-randomized Control Trial of PAX Good Behavior Game in Swedish Elementary Schools
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PAX Good Behavior Game, Count on Me!, Collegial Learning Community.
- Кому может быть актуально
- Состояния в реестре: Well-being in Elementary School Children, Mental Health in Elementary School Children, Work-related Stress in Teachers, Academic Performance in Elementary School Children. Базовые параметры: 6 лет — 10 лет · Все.
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- Где проводится
- Швеция
- Следующий шаг
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Официальное название
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
Обзор
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.
Подробное описание
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.
Credible control interventions requiring the same amount of training and supervision will be used, to control for unspecific effects of implementing a new method. It also makes it possible to promote the study to schools and teachers as a way to implement and compare several useful methods, although for different purposes, which helps to avoid too high expectation or placebo effects for PAX and to minimize possible disappointment and nocebo effects related to having to wait one year before starting with PAX. The school will have the possibility to choose one of the two control interventions - a math application, 'Count On Me!', or Collegial learning community. This serves two purposes; (1) the possibility to choose will further reduce the risk of nocebo or being dissatisfied if not randomized to PAX and (2) it will enable more schools to participate if one of the control interventions would be seen as impractical to implement. Since neither fo the control interventions are deemed to have the same specific effects as PAX, at least not to the same extent, they will both act as controls for unspecific effects.
A total of seven measures will be administered in relation to pupils, teachers and the classroom during the two years, with the baseline (Measurement 0) at the end of the semester before the implementation starts (Semester 0) and the primary endpoint (Measurement 4) one year afterwards. To reduce the burden for teachers and pupils, the full range of outcome measures will be conducted only on two occasions (Measurement 0 and Measurement 4) and otherwise a reduced set of measures will be used for pupils and teachers (For measures on classroom level, the full set of measures will always be applied). The reduced set of self-rating measures for teachers will include work related stress (primary outcome), classroom management, general stress, sleep problems, work ability and observed negative/positive effects of the method being implemented. For pupils, the reduced set will contain questions on well-being (primary measure). Teachers will also measure the well-being for each pupil at each measurement point.
Following time frames will apply to the measurement points:
Measurement 0 (M0) - semester before the first implementation semester, a 4-weeks administration window ending two weeks before the end of the semester.
Measurement 1 (M1) - the first implementation semester, a 6-weeks administration window starting two weeks after the start of the semester (and preferably two weeks after the completion of the intervention training).
Measurement 2 (M2) - the first implementation semester, a 4-weeks administration window ending two weeks before the end of the semester).
Measurement 3 (M3) - the second implementation semester, a 4-weeks administration window starting two weeks after the start of the semester).
Measurement 4 (M4) - primary endpoint, the second implementation semester, a 4-weeks administration window ending two weeks before the end of the semester.
Measurement 5 (M5) - the third implementation semester, a 4-weeks administration window ending two weeks before the end of the semester.
Measurement 6 (M6) - the fourth implementation semester, a 4-weeks administration window ending two weeks before the end of the semester.
Participants and recruitment
Schools, teachers, classrooms and other school staff
The cluster-randomization will be performed on the school-level, and will in turn decide which teachers and pupils that are included. The schools will be recruited via an established network of PAX GBG trainers in Sweden and the research groups other connections with school-related networks and the recruitment will be country wide. The schools will be recruited from at least two different Regions and at least four different municipalities (kommuner) to increase the generalizability of the results. In total, around 28 schools will be included, depending on the number of classrooms participating from each school.
A total of 84 classes, with an expected total of up to 100 teachers (as some classes have more than one teacher) will be included in the project.
Other school staff is recruited only to participate in the qualitative evaluation of expectations and experiences of the interventions. The selection of these will be pragmatic and theoretically lead to reaching a saturation of qualitative data, with a maximum of four extra staff from each school.
Pupils and their participation in interventions and data collection
In total, 2200 pupils will be included, with approximately 26 pupils included from each classroom. All the pupils in a class related to the included teachers/classrooms will participate in the intervention since those are all implemented in the regular operation/teaching at the school and focused on the teachers' way of teaching and managing the class and the classroom and is not possible to exclude specific pupils from. Pupils can however be included in the data collection in three different ways:
* Data from pupils to parents/custodians having signed the informed consent will have the data from their self-ratings, from the teachers ratings of them, and from registries connected to an ID-number, which in turn can be connected to their social security number (personnummer). * Data on pupils whose parents have not filled out the consent will still be collected, but without any ID-number or other identifier, which makes it impossible to connect it to the specific pupil and hence make the data anonymous. Only the interventions the pupil has been randomized to, and at which time-point the data was collected, is connected to this data. * Parents/custodians and the pupil himself/herself will be informed that the pupils do not need to fill out the self-ratings if they inform the teacher or researchers about their wish. Pupils will be informed of this before each self-rating.
Randomization
To ensure that the socioeconomic status (SES) of the schools do not differ too much, each school will be classified as being low, middle, or high SES and then, when there are enough schools in a cohort, randomized consecutively according to one of three corresponding block-randomized lists with block sizes varying randomly between 2, 4 and 6. The randomization will be handled by an independent third party, the Karolinska Trial Alliance, to ensure the researchers are not able to assess the lists or otherwise predict randomization results.
Interventions
The implementation procedure will be similar for each intervention, with smaller adjustments to fit specific needs of each method. Each starts with brief initial written information about the interventions, followed by one to two days of training/education for teachers. This is then followed by regular supervision face-to-face or via video/telephone depending on practical aspects and possible restrictions due to the Covid-19 pandemic. Supervision always includes some form of observation and monitoring of the use of the method by the supervisor, as a source to further inform the supervision. A total of six supervision sessions are planned: 4 sessions during the first implementation semester (held during the 1st to 4rth quarter of the semester respectively, starting with 2 individual sessions, followed by 1 group session and then by 1 individual session) and 2 sessions during the second implementation semester (held during the 1st and 2nd half of the semester respectively, 1 group session followed by 1 individual session). Teachers in all groups will also be able to receive briefer supervision on demand or additional supervision sessions initiated by the supervisor if deemed necessary.
PAX Good Behavior Game
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. PAX GBG is packaged into ten specific tools that the teachers are trained to introduce 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 (4 sessions) and in group (2 sessions) and includes that the PAX-trainer observes a lecture given by the teacher before each supervision session.
Count On Me! (Control condition)
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. 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 originally developed by Tiemann and Markle and later slightly revised by other researchers while creating Headsprout Early Reading and Headsprout Reading Comprehension. Instructional design elements from Tiemann and Markle, explicit instruction and the Morningside model of generative instruction were used to build the exercises. The math exercises contain at least one of three recurrent phases used in all training: the modeling, guide, and fluency phase. Modeling of new skills involves animations and hand-drawn examples along with audial instructions and requires frequent untimed student responding. Guided practice of newly modeled skills helps students achieve high levels of accuracy without timing. Finally, fluency building is aimed at developing proficiency with the skill at hand using timing.
Вмешательства
- Поведенческое PAX Good Behavior Game
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. - Поведенческое Count on Me!
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 Cl - Поведенческое Collegial Learning Community
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.
Первичные конечные точки
- [Pupil-focused] KIDSCREEN-10 extended with 3 items [Срок оценки: Up to 24 months. See Detailed Description section for the details of the measurement points.]
- [Pupil-focused] KIDSCREEN-10 extended Teacher-rated [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: Up to 24 months. See Detailed Description section for the details of the measurement points.]
Вторичные конечные точки (12)
- [Pupil-focused] Child Health Utilities - 9 dimensions (CHU9D) [Срок оценки: At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.]
- [Pupil-focused] KIDSCREEN-10 [Срок оценки: 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] [Срок оценки: 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] [Срок оценки: At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.]
- [Pupil-focused] School absence [Срок оценки: 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] The parents' need to stay home from work in order to take care of a sick child [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: At baseline, then after 12 and 24 months. See Detailed Description section for the details of the measurement points.]
- [Pupil-focused] LegiLexi [Срок оценки: 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). [Срок оценки: Up to 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) [Срок оценки: Up to 24 months. See Detailed Description section for the details of the measurement points.]
Критерии участия
ON SCHOOL LEVEL:
Критерии включения
- 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)
Критерии исключения
- 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:
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Швеция · 1 центр
- Several Schools in Sweden will be recruited, although as participants and not independent — Stockholm
Идентификаторы
NCT: NCT05407623 · 2020-03848