Problem Behaviors Among StudentsNCT01670591
Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level
A study testing PS - Prevention in School in people with Problem Behaviors Among Students and Classroom Learning Environment, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Behaviors Among Students, Classroom Learning Environment
- What is being tested?
- PS - Prevention in School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,207 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to May 2012
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools situated in Stockholm county and in bordering counties within travelling distance from Stockholm.
- Comprising the grades 4-9 (10-15 years).
- A minimum of 2 classes/50 students in each of the grades 5-7.
- A majority (min.80%)of the staff is positive towards program participation.
- School management willing to take active part in change/developmental work.
- A willingness to submit to study conditions (randomization etc)
Who cannot join
- Participation in other ongoing research projects.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet
Stockholm, 10231
About this study
Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. By defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. Against this background, the purpose of this study is to examine whether PS is more effective than schools' ordinary practices in meeting these goals.
- Being tested
- PS - Prevention in School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS - Prevention in SchoolBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PS - Prevention in School | Experimental | Teachers learn to use the core program components (defining and teaching school rules and the handling of rule breakings, principles of positive behavior support)with help from external consultants during approximately 1.5 years. Receives: Behavioral: PS - Prevention in School |
| Business as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student problem behaviors
- Teacher-reported problem behaviors in school areas during last week
- Teacher-reported problem behaviors in classrooms during last week
- Student-reported problem behaviors in school areas during the school-year
- Student-reported problem behaviors in classrooms during the school-year
Measured: 24 months
Secondary outcomes (1)
Classroom learning climate
- Teacher self-reports; Teacher Classroom Climate Scale
- Student self-reports; Student Classroom Climate Scale
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Problem Behaviors Among StudentsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Bodin, Karolinska Institutet
- Investigators
- Maria Bodin, Principal investigator, STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670591
- Sponsor's protocol ID
- 21-12050/2008
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Horner RH, Todd AW, Lewis-Palmer T, Irvin LK, Sugai G, & Boland JB. The school-wide evaluation tool (SET): A research instrument for assessing school-wide positive behaviour support. Journal of Positive Behavior Interventions, 6, 3-12, 2004.
Sundell K, Koutakis N, Hellqvist A, Andrén J, Karlberg M, Forster M & Hassler-Hallstedt M. Prevention i skolan. Forskningsbaserat preventionsprogram för grundskolans år 4-9. FoU-rapport 2007:6. Stockholms stadsledningskontor: FoU-enheten, 2007.
Sørlie M-A, Ogden T. Immediate impacts of PALS: A school wide multi-level programme targeting behaviour problems in elementary school. Scandinavian Journal of Educational Research, 5: 471-492, 2007.
Sørlie M-A, Nordahl, T. Problematferd i skolen: Hovedfunn, forklaringer og pedagogiske implikasjoner. [Behaviour problems in school: Main findings, explanations, and pedagogical implications].Hovedrapport fra forskningsprosjektet Skole- och samspillsvansker (Rapport 12a/98). Oslo: Norsk Institutt for forsknings om oppvekst, velferd og aldring, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level
- ClinicalTrials.gov ID
- NCT01670591
- Acronym / sponsor ID
- 21-12050/2008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,207 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Aug 2012 (estimated)
- 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.
Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. By defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. Against this background, the purpose of this study is to examine whether PS is more effective than schools' ordinary practices in meeting these goals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS - Prevention in School | Experimental | Behavioral: PS - Prevention in SchoolTeachers learn to use the core program components (defining and teaching school rules and the handling of rule breakings, principles of positive behavior support)with help from external consultants during approximately 1.5 years. |
| Business as usual | No intervention | – |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Schools situated in Stockholm county and in bordering counties within travelling distance from Stockholm.
- Comprising the grades 4-9 (10-15 years).
- A minimum of 2 classes/50 students in each of the grades 5-7.
- A majority (min.80%)of the staff is positive towards program participation.
- School management willing to take active part in change/developmental work.
Key exclusion criteria (1 listed)
- Participation in other ongoing research projects.
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 |
|---|---|---|
| PS - Prevention in School | Behavioural | PS - Prevention in School |
Primary outcome
Student problem behaviors
Time frame: 24 months
1. Teacher-reported problem behaviors in school areas during last week 2. Teacher-reported problem behaviors in classrooms during last week 3. Student-reported problem behaviors in school areas during the school-year 4. Student-reported problem behaviors in classrooms during the school-year
1 secondary outcome
Classroom learning climate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- BackgroundHorner RH, Todd AW, Lewis-Palmer T, Irvin LK, Sugai G, & Boland JB. The school-wide evaluation tool (SET): A research instrument for assessing school-wide positive behaviour support. Journal of Positive Behavior Interventions, 6, 3-12, 2004.
- BackgroundSundell K, Koutakis N, Hellqvist A, Andrén J, Karlberg M, Forster M & Hassler-Hallstedt M. Prevention i skolan. Forskningsbaserat preventionsprogram för grundskolans år 4-9. FoU-rapport 2007:6. Stockholms stadsledningskontor: FoU-enheten, 2007.
- BackgroundSørlie M-A, Ogden T. Immediate impacts of PALS: A school wide multi-level programme targeting behaviour problems in elementary school. Scandinavian Journal of Educational Research, 5: 471-492, 2007.
- BackgroundSørlie M-A, Nordahl, T. Problematferd i skolen: Hovedfunn, forklaringer og pedagogiske implikasjoner. [Behaviour problems in school: Main findings, explanations, and pedagogical implications].Hovedrapport fra forskningsprosjektet Skole- och samspillsvansker (Rapport 12a/98). Oslo: Norsk Institutt for forsknings om oppvekst, velferd og aldring, 1998.
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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.
Maria Bodin principal investigator
STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS - Prevention in School in people with Problem Behaviors Among Students and Classroom Learning Environment, run by Karolinska Institutet 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student problem behaviors (time frame: 24 months). 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 NCT01670591, which also lists 4 linked publications.
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 22 Aug 2012.