Behavior ProblemIBISNCT06270914
Inclusive Positive Behaviour Supports
A study testing Inclusive Positive Behavior Interventions and Supports in people with Behavior Problem and Social Skills, run by Uppsala University at 1 site in Sweden.
Trial summary
Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Social Skills
- What is being tested?
- Inclusive Positive Behavior Interventions and Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- 25 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- compulsory school, grades 4-9;
- the school have not been previously enrolled in an SWPBIS program by other providers;
- principal, teachers, students and their parents consent to participate in the study.
Who cannot join
- grades other than 4-9;
- the school has previously received or is enrolled in SWPBIS program or other PBS program;
- students or their parents have not consented to participation in the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Education
Uppsala, Uppland, 752 37
Martin Karlberg, PhD, 018-471 1669, martin.karlberg@edu.uu.se
Nina Klang, PhD, 018-471 1674, nina.klang@edu.uu.se
About this study
Official title: Inclusive Positive Behavior Support in School - the Causal Mechanisms and Interactive Processes. A Study Protocol
Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups.
Read the detailed description
Aim and Research Questions:
Firstly, the aim is to evaluate the effectiveness of the SWPBIS program for students' socio-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment, and to explore how school-level factors may moderate or mediate the effect of SWPBIS on the outcomes. Secondly, the aim is to gain a deeper understanding of the social processes and local meanings that emerge and take form among the students, teachers, and other school professionals as they participate in the SW-PBIS program. The aims are specified in four research questions:
- What are the effects of the SW-PBIS program on students' socio-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment?
- To what extent do school-level factors mediate and moderate the effects of the SW-PBIS program on the study outcomes over time?
- How are the central contents of the SW-PBIS program made sense of and negotiated in school teams and classrooms at two schools during the course of program implementation?
- How do specific instances of student-teacher interaction lead to changes in students' behavior and responses to the SW-PBIS program, and what forms of ethical dilemmas evolve in the management of behavior problems in classrooms?
Methods:
This study utilizes a quasi-experimental non-randomized design, including two waves of participant recruitment. In the first wave of recruitment, intervention and active control groups are used, and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to gain a deeper understanding of the process of implementing SWPIS. In the second wave of data recruitment, intervention and wait-list control groups are used, and outcomes will be measured at two time points (pre- and post).
The study will be conducted in compulsory schools and will include classes from grade four to grade nine. Each of the two waves of recruitment in the study will include 80 schools. Data will be collected on school-level measures and individual-level measures. School-level measures encompass: (a) Teacher collective self-efficacy; (b) Problem behavior in the classroom and school. Individual-level measures encompass: (a) Social-emotional skills; (b) Classroom environment; (c) Student achievement in national tests of mathematics and literacy.
The intervention is based on the Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Samhandling). The Norwegian model shares its core components with the original SW-PBIS model. The program's core components constitute: (a) Positive behavior support strategies, including positive expectations and classroom rules, which are followed up with positive feedback and encouragement; (b) A system for monitoring student behavior, (c) School-wide corrections using consequences, (d) Instruction in classroom management skills for teachers, and (e) Strategies for collaboration with parents. These components are implemented through activities at the school level and at the classroom level. The implementation at the school level starts with establishing a leadership team, comprised of school leaders, team leaders, and members of the school welfare team. The leadership team assesses the needs and resources at the school and agrees on behavioral expectations and rules. The team monitors student behaviors and provides opportunities for teacher professional development with a focus on classroom management and relationship building. At the classroom level, the teachers incorporate school-wide expected behaviors into their classroom instruction through classroom activities and classroom rules. The teachers also integrate their training in classroom management and relationship building into their teaching practices. The duration of Tier 1 intervention is expected to be three years.
The control group in the first wave of data collection is selected in accordance with a quasi-experimental design with a nonequivalent control group. The teachers in the control group will, instead of a wait-list intervention, receive a shortened version of SW-PBIS containing only classroom leadership lectures. The schools that are part of the classroom management group also send staff for instructor training (ten training sessions, 25 hours in total, just as much as the SW-PBIS schools). Similar to the SW-PBIS group, the instructors in this group educate and supervise school staff, supported by a team at the school. Both groups have access to a manual and supporting materials. This design does not pose threats to the internal validity of the study, as classroom leadership is one of the principles of the PBIS framework. In this way, it will be possible to explore the specific contribution of schoolwide PBS in contrast to classroom leadership only. The control group in the second wave of data collection constitutes a wait-list control group and will not be engaged in any kind of intervention during the intervention period.
Hierarchical regression analyses with a three-level structure will be conducted to explore the effects of SW-PBIS on study outcomes. Hierarchical regression analyses allow for accounting for the nested structure of the data, in which teachers' and students' responses are nested within schools and grade levels. The outcomes at the school and individual levels will be studied as a function of time (three time points for wave 1 and two time points for wave 2) and group belonging (intervention or control group). To take into account the nestedness of the data, a three-level random effect model will be used, varying by school, grade, and the individuals' identification codes. Furthermore, the possible mediators (quality of implementation) and moderators (school characteristics, school-level variables) of the SWPBIS intervention will be analyzed. Missing data will be handled by imputation, provided that the assumption of data missing completely at random is met.
In the qualitative study, a longitudinal ethnographic approach will be used in order to obtain detailed contextualized knowledge on interactions in various contexts in two of the intervention schools, recruited in wave 1, over a longer period of time. Through purposeful sampling, three schools with different characteristics regarding size and catchment area will be selected.
- Conditions
- Behavior Problem, Social Skills
- Being tested
- Inclusive Positive Behavior Interventions and Supports
- Keywords
- behavior problem, positive behavior support, prevention, universal
- Medical subject headings
- Mental Disorders, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusive Positive Behavior Interventions and SupportsBehavioural
The intervention is based on the Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Sammhandling). The Norwegian model shares its core components with the original SW-PBIS model. The program's core components constitute: (a) positive behavior support strategies, including positive expectations and classroom rules, which are followed up with positive feedback and encouragement; (b) a system for monitoring student behavior, (c) school-wide corrections using consequences, (c) instruction in classroom management skills for teachers, and (e) strategies for collaboration with parents. These components are implemented through activities at school level and at classroom level.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive the intervention Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Sammhandling). Receives: Behavioral: Inclusive Positive Behavior Interventions and Supports |
| Active control | Active comparator | Control group in the first wave of data collection is selected in accordance quasi-experimental design with nonequivalent control group. The teachers in the control group will, instead of a wait-list intervention, a shortened version of SW-PBIS containing only classroom leadership lectures. The schools that are part of the classroom management group also send staff for instructor training (ten training sessions, 25 hours in total, just as much as the SW-PBIS schools). Similar to the SW-PBIS group, the instructors in this group educate and supervise school staff, supported by a team at the school. Both groups have access to a manual and supporting materials. This design does not pose threats to the internal validity of the study, as classroom leadership is one of principles of PBIS framework. In this way it will be possible to explore the specific contribution of schoolwide PBS in contrast to classroom leadership only. Receives: Behavioral: Inclusive Positive Behavior Interventions and Supports |
| Control | No intervention | Control group in the second wave of data collection constitutes a wait-list control group and will not be engaged in any kind of intervention during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social emotional skills
Social Skills Improvement System - SEL Brief and Mental Health Scales, Teacher K-12 Form contains 20 items related to five competency domains (self-awareness, self-management, social awareness, relationship skills, and responsible decision making) and 10 items encompassing emotional behavior concerns (internalizing and externalizing concerns). Examples of items are "Asks for help when needed" for social-emotional skills competency domains and "Withdraws from others" for emotional behavior concerns. The items are measured on a 4-point scale (1=Never, 2=Seldom, 3=Often, 4=Almost always). The measures have proved to have sufficient validity and reliability in previous studies.
Measured: 11 months
Classroom environment
A comprehensive assessment of the classroom learning environment was conducted using questionnaires for teachers and students. The teacher questionnaire consisted of 14 statements, rated on a 4-point scale (1 = does not fit to 4 = fits completely), assessing various aspects of the classroom learning climate. The student questionnaire included 22 statements, also rated on a 4-point scale, gauging students' perceptions of the classroom environment. An example of an item in the teacher questionnaire is "There is a good working climate during lessons". An example of an item in the student questionnaire is "Students in this class are active and interested during lessons".
Measured: 11 months
Students' achievement
students' achievement on national tests of Swedish and mathematics will be retrieved from register data provided by Statistics Sweden. The data will be standardized across tests and compared with regard to the national average for those students who enter the project in grade 4 and 7 (national tests in grade 3 and grade 6) and finish the project in grade 6 and 9 (national tests in grade 6 and grade 9).
Measured: 11 months
Secondary outcomes (2)
Collective self-efficacy
Collective Self-efficacy questionnaire will be used as a measure of teacher collective beliefs of possibilities to influence student learning. CES contains 12 items and a 6-point scale is used (from 1=Do not agree at all, 2=Do not agree, 3=Do not agree fully, 4=Agree a little, 5=Agree, 6=Agree completely). An example of item is "Teachers in this school are able to get through to difficult students". In previous studies, collective self-efficacy has shown to be influenced by SWPBIS programs.
Measured: 11 months
Problem behavior in classroom and school
Problem Behavior in the Classroom Last Week (20 items), in which the teachers are asked to report disruptive behavior on a 5-point Likert scale from 0 (not observed) to 5 (observed several times per day). Problem Behavior in the School Environment is a school level measure with similar structure and rating alternatives and is used with school staff. Examples of behaviors in the scales are "Destroying school environment" or "Physical aggression towards peers and teachers". The scales have shown satisfactory psychometric properties in several prior Norwegian studies.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start25 Aug 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post).
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Martin Karlberg, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270914
- Sponsor's protocol ID
- IBIS
- Acronym
- IBIS
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be made available to other researchers due to ethical considerations.
Publications
Karlberg M, Klang N, Svahn J. Positive behavior support in school - a quasi-experimental mixed methods study and a randomized controlled trial. BMC Psychol. 2024 Oct 1;12(1):521. doi: 10.1186/s40359-024-02021-z.
PubMed 39354572
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusive Positive Behavior Support in School - the Causal Mechanisms and Interactive Processes. A Study Protocol
- ClinicalTrials.gov ID
- NCT06270914
- Acronym / sponsor ID
- IBIS / IBIS
- Conditions
- Behavior Problem, Social Skills
- Keywords
- behavior problem, positive behavior support, prevention, universal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups.
Detailed description
Aim and Research Questions:
Firstly, the aim is to evaluate the effectiveness of the SWPBIS program for students' socio-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment, and to explore how school-level factors may moderate or mediate the effect of SWPBIS on the outcomes. Secondly, the aim is to gain a deeper understanding of the social processes and local meanings that emerge and take form among the students, teachers, and other school professionals as they participate in the SW-PBIS program. The aims are specified in four research questions:
- What are the effects of the SW-PBIS program on students' socio-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment?
- To what extent do school-level factors mediate and moderate the effects of the SW-PBIS program on the study outcomes over time?
- How are the central contents of the SW-PBIS program made sense of and negotiated in school teams and classrooms at two schools during the course of program implementation?
- How do specific instances of student-teacher interaction lead to changes in students' behavior and responses to the SW-PBIS program, and what forms of ethical dilemmas evolve in the management of behavior problems in classrooms?
Methods:
This study utilizes a quasi-experimental non-randomized design, including two waves of participant recruitment. In the first wave of recruitment, intervention and active control groups are used, and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to gain a deeper understanding of the process of implementing SWPIS. In the second wave of data recruitment, intervention and wait-list control groups are used, and outcomes will be measured at two time points (pre- and post).
The study will be conducted in compulsory schools and will include classes from grade four to grade nine. Each of the two waves of recruitment in the study will include 80 schools. Data will be collected on school-level measures and individual-level measures. School-level measures encompass: (a) Teacher collective self-efficacy; (b) Problem behavior in the classroom and school. Individual-level measures encompass: (a) Social-emotional skills; (b) Classroom environment; (c) Student achievement in national tests of mathematics and literacy.
The intervention is based on the Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Samhandling). The Norwegian model shares its core components with the original SW-PBIS model. The program's core components constitute: (a) Positive behavior support strategies, including positive expectations and classroom rules, which are followed up with positive feedback and encouragement; (b) A system for monitoring student behavior, (c) School-wide corrections using consequences, (d) Instruction in classroom management skills for teachers, and (e) Strategies for collaboration with parents. These components are implemented through activities at the school level and at the classroom level. The implementation at the school level starts with establishing a leadership team, comprised of school leaders, team leaders, and members of the school welfare team. The leadership team assesses the needs and resources at the school and agrees on behavioral expectations and rules. The team monitors student behaviors and provides opportunities for teacher professional development with a focus on classroom management and relationship building. At the classroom level, the teachers incorporate school-wide expected behaviors into their classroom instruction through classroom activities and classroom rules. The teachers also integrate their training in classroom management and relationship building into their teaching practices. The duration of Tier 1 intervention is expected to be three years.
The control group in the first wave of data collection is selected in accordance with a quasi-experimental design with a nonequivalent control group. The teachers in the control group will, instead of a wait-list intervention, receive a shortened version of SW-PBIS containing only classroom leadership lectures. The schools that are part of the classroom management group also send staff for instructor training (ten training sessions, 25 hours in total, just as much as the SW-PBIS schools). Similar to the SW-PBIS group, the instructors in this group educate and supervise school staff, supported by a team at the school. Both groups have access to a manual and supporting materials. This design does not pose threats to the internal validity of the study, as classroom leadership is one of the principles of the PBIS framework. In this way, it will be possible to explore the specific contribution of schoolwide PBS in contrast to classroom leadership only. The control group in the second wave of data collection constitutes a wait-list control group and will not be engaged in any kind of intervention during the intervention period.
Hierarchical regression analyses with a three-level structure will be conducted to explore the effects of SW-PBIS on study outcomes. Hierarchical regression analyses allow for accounting for the nested structure of the data, in which teachers' and students' responses are nested within schools and grade levels. The outcomes at the school and individual levels will be studied as a function of time (three time points for wave 1 and two time points for wave 2) and group belonging (intervention or control group). To take into account the nestedness of the data, a three-level random effect model will be used, varying by school, grade, and the individuals' identification codes. Furthermore, the possible mediators (quality of implementation) and moderators (school characteristics, school-level variables) of the SWPBIS intervention will be analyzed. Missing data will be handled by imputation, provided that the assumption of data missing completely at random is met.
In the qualitative study, a longitudinal ethnographic approach will be used in order to obtain detailed contextualized knowledge on interactions in various contexts in two of the intervention schools, recruited in wave 1, over a longer period of time. Through purposeful sampling, three schools with different characteristics regarding size and catchment area will be selected.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Inclusive Positive Behavior Interventions and SupportsThe intervention group will receive the intervention Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Sammhandling). |
| Active control | Active comparator | Behavioral: Inclusive Positive Behavior Interventions and SupportsControl group in the first wave of data collection is selected in accordance quasi-experimental design with nonequivalent control group. The teachers in the control group will, instead of a wait-list intervention, a shortened version of SW-PBIS containing only classroom leadership lectures. The schools that are part of the classroom management group also send staff for instructor training (ten training sessions, 25 hours in total, just as much as the SW-PBIS schools). Similar to the SW-PBIS group, the instructors in this group educate and supervise school staff, supported by a team at the school. Both groups have access to a manual and supporting materials. This design does not pose threats to the internal validity of the study, as classroom leadership is one of principles of PBIS framework. In this way it will be possible to explore the specific contribution of schoolwide PBS in contrast to classroom leadership only. |
| Control | No intervention | –Control group in the second wave of data collection constitutes a wait-list control group and will not be engaged in any kind of intervention during the intervention period. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- compulsory school, grades 4-9;
- the school have not been previously enrolled in an SWPBIS program by other providers;
- principal, teachers, students and their parents consent to participate in the study.
Key exclusion criteria (3 listed)
- grades other than 4-9;
- the school has previously received or is enrolled in SWPBIS program or other PBS program;
- students or their parents have not consented to participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclusive Positive Behavior Interventions and SupportsThe intervention is based on the Norwegian manualized program of SW-PBIS, N-PALS (Positiv Atferd, Støttende Læringsmiljø, og Sammhandling). The Norwegian model shares its core components with the original SW-PBIS model. The program's core components constitute: (a) positive behavior support strategies, including positive expectations and classroom rules, which are followed up with positive feedback and encouragement; (b) a system for monitoring student behavior, (c) school-wide corrections using consequences, (c) instruction in classroom management skills for teachers, and (e) strategies for collaboration with parents. These components are implemented through activities at school level and at classroom level. | Behavioural | Active control, Intervention |
Primary outcome
Social emotional skills
Time frame: 11 months
Social Skills Improvement System - SEL Brief and Mental Health Scales, Teacher K-12 Form contains 20 items related to five competency domains (self-awareness, self-management, social awareness, relationship skills, and responsible decision making) and 10 items encompassing emotional behavior concerns (internalizing and externalizing concerns). Examples of items are "Asks for help when needed" for social-emotional skills competency domains and "Withdraws from others" for emotional behavior concerns. The items are measured on a 4-point scale (1=Never, 2=Seldom, 3=Often, 4=Almost always). The measures have proved to have sufficient validity and reliability in previous studies.
Classroom environment
Time frame: 11 months
A comprehensive assessment of the classroom learning environment was conducted using questionnaires for teachers and students. The teacher questionnaire consisted of 14 statements, rated on a 4-point scale (1 = does not fit to 4 = fits completely), assessing various aspects of the classroom learning climate. The student questionnaire included 22 statements, also rated on a 4-point scale, gauging students' perceptions of the classroom environment. An example of an item in the teacher questionnaire is "There is a good working climate during lessons". An example of an item in the student questionnaire is "Students in this class are active and interested during lessons".
Students' achievement
Time frame: 11 months
students' achievement on national tests of Swedish and mathematics will be retrieved from register data provided by Statistics Sweden. The data will be standardized across tests and compared with regard to the national average for those students who enter the project in grade 4 and 7 (national tests in grade 3 and grade 6) and finish the project in grade 6 and 9 (national tests in grade 6 and grade 9).
2 secondary outcomes
Collective self-efficacy
Time frame: 11 months
Problem behavior in classroom and school
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 39354572Karlberg M, Klang N, Svahn J. Positive behavior support in school - a quasi-experimental mixed methods study and a randomized controlled trial. BMC Psychol. 2024 Oct 1;12(1):521. doi: 10.1186/s40359-024-02021-z.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be made available to other researchers due to ethical considerations.
Related trials for Behavior Problem
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
Recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Recruiting
Family Spirit Strengths
Depressive Symptoms, Anxiety Disorders and Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclusive Positive Behavior Interventions and Supports in people with Behavior Problem and Social Skills, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Karlberg, PhD (018-471 1669, martin.karlberg@edu.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social emotional skills (time frame: 11 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.