<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670591</url>
  </required_header>
  <id_info>
    <org_study_id>21-12050/2008</org_study_id>
    <nct_id>NCT01670591</nct_id>
  </id_info>
  <brief_title>Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the&#xD;
      universal prevention level, developed by Swedish researchers for the school years 4 -9. By&#xD;
      defining and teaching school rules to all teachers and students, and by consistently&#xD;
      acknowledging students when meeting behavioural expectations, the program aims to reduce&#xD;
      problem behaviours in school areas and to improve the classroom learning climate. Against&#xD;
      this background, the purpose of this study is to examine whether PS is more effective than&#xD;
      schools' ordinary practices in meeting these goals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Student problem behaviors</measure>
    <time_frame>24 months</time_frame>
    <description>Teacher-reported problem behaviors in school areas during last week&#xD;
Teacher-reported problem behaviors in classrooms during last week&#xD;
Student-reported problem behaviors in school areas during the school-year&#xD;
Student-reported problem behaviors in classrooms during the school-year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Classroom learning climate</measure>
    <time_frame>24 months</time_frame>
    <description>Teacher self-reports; Teacher Classroom Climate Scale&#xD;
Student self-reports; Student Classroom Climate Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3207</enrollment>
  <condition>Problem Behaviors Among Students</condition>
  <condition>Classroom Learning Environment</condition>
  <arm_group>
    <arm_group_label>PS - Prevention in School</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Business as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PS - Prevention in School</intervention_name>
    <arm_group_label>PS - Prevention in School</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schools situated in Stockholm county and in bordering counties within travelling&#xD;
             distance from Stockholm.&#xD;
&#xD;
          -  Comprising the grades 4-9 (10-15 years).&#xD;
&#xD;
          -  A minimum of 2 classes/50 students in each of the grades 5-7.&#xD;
&#xD;
          -  A majority (min.80%)of the staff is positive towards program participation.&#xD;
&#xD;
          -  School management willing to take active part in change/developmental work.&#xD;
&#xD;
          -  A willingness to submit to study conditions (randomization etc)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other ongoing research projects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Bodin</last_name>
    <role>Principal Investigator</role>
    <affiliation>STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <zip>10231</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Horner RH, Todd AW, Lewis-Palmer T, Irvin LK, Sugai G, &amp; 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.</citation>
  </reference>
  <reference>
    <citation>Sundell K, Koutakis N, Hellqvist A, Andrén J, Karlberg M, Forster M &amp; Hassler-Hallstedt M. Prevention i skolan. Forskningsbaserat preventionsprogram för grundskolans år 4-9. FoU-rapport 2007:6. Stockholms stadsledningskontor: FoU-enheten, 2007.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Maria Bodin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670591
org study id: 21-12050/2008
nct id: NCT01670591
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Student problem behaviors
time frame: 24 months
description: 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
measure: Classroom learning climate
time frame: 24 months
description: Teacher self-reports; Teacher Classroom Climate Scale
Student self-reports; Student Classroom Climate Scale
arm group label: PS - Prevention in School
arm group type: Experimental
description: 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.
arm group label: Business as usual
arm group type: No Intervention
intervention type: Behavioral
intervention name: PS - Prevention in School
arm group label: PS - Prevention in School
criteria: 
gender: All
minimum age: 10 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Bodin
role: Principal Investigator
affiliation: STAD, Stockholm Centre for Psychiatric Research and Education, Karolinska Institutet
facility: 
country: Sweden
citation: 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.
citation: 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.
citation: 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.
citation: 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.
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Maria Bodin
investigator title: Principal Investigator
mesh term: Problem Behavior