xml: <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/NCT06040437</url>
    </required_header>
    <id_info>
      <org_study_id>105246</org_study_id>
      <nct_id>NCT06040437</nct_id>
    </id_info>
    <brief_title>Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.</brief_title>
    <acronym>Be-Prox</acronym>
    <official_title>Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NORCE Norwegian Research Centre AS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Tromso</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bjørnafjorden municipality</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Narvik municipality</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NORCE Norwegian Research Centre AS</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian&#xD;
        children in accordance with the Kindergarten Act §§41-43, the objectives of the current&#xD;
        project are:&#xD;
  &#xD;
        To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and&#xD;
        bullying among peers in Norwegian kindergartens.&#xD;
  &#xD;
        To examine implementation factors that promote and inhibit the effectiveness of Be-Prox&#xD;
        Norway in Norwegian kindergartens.&#xD;
  &#xD;
        To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian&#xD;
        kindergartens.&#xD;
  &#xD;
        To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented&#xD;
        in Norwegian kindergartens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        January 1st, 2021, new additions to the Kindergarten Act came into force in Norway&#xD;
        introducing the right for all children to a safe and sound kindergarten environment.&#xD;
        According to this act, Norwegian kindergartens shall systematically work to preventing&#xD;
        bullying and social exclusion, including adopting a zero-tolerance for violations such as&#xD;
        exclusion, bullying, violence, discrimination, and harassment. While relatively little is&#xD;
        known about bullying at this age, a growing body of research suggests that bullying occurs&#xD;
        also between kindergarten peers and that experiencing bullying at early age is associated&#xD;
        with negative consequences.&#xD;
  &#xD;
        Currently there are few evidence-based interventions directly targeting bullying among&#xD;
        kindergarten peers. Be-Prox, developed for Swiss kindergartens to prevent, uncover and handle&#xD;
        negative behavior and bullying in kindergartens have been translated and adjusted to a&#xD;
        Norwegian context in a previous pilot study.&#xD;
  &#xD;
        The current project is a close collaboration between two Norwegian municipalities, regional&#xD;
        centres for child and youth mental health and welfare, and research and educational&#xD;
        institutions.&#xD;
  &#xD;
        The project aims to evaluate the effectiveness of the Be-Prox Norway in a cluster randomized&#xD;
        controlled trial, including process and implementation evaluation and cost-effectiveness&#xD;
        analyses. Hence the project complies with the current call through introducing research on&#xD;
        tools, systems and models that promote evidence-based practices in Norwegian kindergartens in&#xD;
        general, and to prevent negative acts and bullying between kindergarten peers in particular.&#xD;
  &#xD;
        If proven effective, Be-Prox Norway can be offered to kindergartens nationwide as&#xD;
        evidence-based practice to prevent, uncover and handle negative behavior and bullying among&#xD;
        Norwegian kindergarten peers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2024</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>
      <intervention_model_description>Cluster-randomized controlled trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in number of children exposing other children to negative behavior</measure>
      <time_frame>Pre- to post-intervention, 9 months</time_frame>
      <description>Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where &quot;exposing others&quot; is defined as exposing others to one of the negative acts &quot;more than once a week&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in number of children exposed by other children to negative behavior</measure>
      <time_frame>Pre- to post-intervention, 9 months</time_frame>
      <description>Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score &quot;being exposed&quot; is defined as being exposing by others to one of the negative acts &quot;more than once a week&quot;.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in number of children exposing other children to negative behavior 1 and 2 years after the intervention</measure>
      <time_frame>1 and 2 year post intervention</time_frame>
      <description>Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where &quot;exposing others&quot; is defined as exposing others to one of the negative acts &quot;more than once a week&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in number of children exposed by other children to negative behavior 1 and 2 years after the intervention</measure>
      <time_frame>1 and 2 year post intervention</time_frame>
      <description>Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score &quot;being exposed&quot; is defined as being exposing by others to one of the negative acts &quot;more than once a week&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in child prosocial bystander behavior</measure>
      <time_frame>Pre- to post-intervention, 9 months and 1 and 2 years post intervention</time_frame>
      <description>12 item questionnaire, Alsaker 2004</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Authoritative climate</measure>
      <time_frame>Pre- to post-intervention, 12 months and then 1 and 2 years following</time_frame>
      <description>10 item scale, adjusted from Ertesvåg, 2011</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in personnel self-efficacy beliefs</measure>
      <time_frame>Pre- to post-intervention, 12 months and then 1 and 2 years following</time_frame>
      <description>5 item scale, adjusted from Fischer, 2019</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in personnel understanding of bullying among children in kindergartens</measure>
      <time_frame>Pre- to post-intervention, 12 months and then 1 and 2 years following</time_frame>
      <description>8 items questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2500</enrollment>
    <condition>Bullying of Child</condition>
    <arm_group>
      <arm_group_label>Be-Prox intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Training in the 6 Be-Prox module</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Be-Prox</intervention_name>
      <description>Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.</description>
      <arm_group_label>Be-Prox intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children born 2018-2020 in kindergartens enrolled to the Be-Prox project and with&#xD;
               parental consent to participate.&#xD;
  &#xD;
            -  Personnel i Norwegian kindergartens enrolled in the Be-Prox project and who consent to&#xD;
               participate.&#xD;
  &#xD;
            -  Parents of children in kindergartens enrolled to the Be-prox project&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  children born 2021-2023&#xD;
  &#xD;
            -  children with no parental consent to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ingrid Kvestad, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>NORCE Norwegian Research Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ingrid Kvestad, Dr</last_name>
      <phone>+4799400431</phone>
      <email>inkv@norceresearch.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Merete Aasheim, Dr.</last_name>
      <phone>+47 99 26 46 30</phone>
      <email>merete.aasheim@uit.no</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NORCE Norwegian Research Center</name>
        <address>
          <city>Bergen</city>
          <zip>5008</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ingrid Kvestad, dr</last_name>
        <phone>+4799400431</phone>
        <email>inkv@norceresearch.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Narvik municipality</name>
        <address>
          <city>Narvik</city>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gro Hoseth, MA</last_name>
        <email>gro.hoseth@narvik.kommune.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bjørnafjorden municipality</name>
        <address>
          <city>Os</city>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Irene K Foer, MA</last_name>
        <email>irfo@bjornafjorden.kommune.no</email>
      </contact>
      <contact_backup>
        <last_name>Lena E Sløgedal, MA</last_name>
        <email>lenslo@bjornafjorden.kommune.no</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of Tromsø</name>
        <address>
          <city>Tromsø</city>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Merete Aasheim, Dr</last_name>
        <email>merete.aasheim@uit.no</email>
      </contact>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Early Childhood and Educational Care</keyword>
    <keyword>Norway</keyword>
    <keyword>Bullying intervention</keyword>
    <keyword>Randomized controlled trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bullying</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040437
  org study id: 105246
  nct id: NCT06040437
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian
        children in accordance with the Kindergarten Act §§41-43, the objectives of the current
        project are:
  
        To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and
        bullying among peers in Norwegian kindergartens.
  
        To examine implementation factors that promote and inhibit the effectiveness of Be-Prox
        Norway in Norwegian kindergartens.
  
        To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian
        kindergartens.
  
        To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented
        in Norwegian kindergartens.
  January 1st, 2021, new additions to the Kindergarten Act came into force in Norway
        introducing the right for all children to a safe and sound kindergarten environment.
        According to this act, Norwegian kindergartens shall systematically work to preventing
        bullying and social exclusion, including adopting a zero-tolerance for violations such as
        exclusion, bullying, violence, discrimination, and harassment. While relatively little is
        known about bullying at this age, a growing body of research suggests that bullying occurs
        also between kindergarten peers and that experiencing bullying at early age is associated
        with negative consequences.
  
        Currently there are few evidence-based interventions directly targeting bullying among
        kindergarten peers. Be-Prox, developed for Swiss kindergartens to prevent, uncover and handle
        negative behavior and bullying in kindergartens have been translated and adjusted to a
        Norwegian context in a previous pilot study.
  
        The current project is a close collaboration between two Norwegian municipalities, regional
        centres for child and youth mental health and welfare, and research and educational
        institutions.
  
        The project aims to evaluate the effectiveness of the Be-Prox Norway in a cluster randomized
        controlled trial, including process and implementation evaluation and cost-effectiveness
        analyses. Hence the project complies with the current call through introducing research on
        tools, systems and models that promote evidence-based practices in Norwegian kindergartens in
        general, and to prevent negative acts and bullying between kindergarten peers in particular.
  
        If proven effective, Be-Prox Norway can be offered to kindergartens nationwide as
        evidence-based practice to prevent, uncover and handle negative behavior and bullying among
        Norwegian kindergarten peers.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Cluster-randomized controlled trial
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in number of children exposing other children to negative behavior
  time frame: Pre- to post-intervention, 9 months
  description: Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where "exposing others" is defined as exposing others to one of the negative acts "more than once a week".
  measure: Change in number of children exposed by other children to negative behavior
  time frame: Pre- to post-intervention, 9 months
  description: Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score "being exposed" is defined as being exposing by others to one of the negative acts "more than once a week".
  measure: Change in number of children exposing other children to negative behavior 1 and 2 years after the intervention
  time frame: 1 and 2 year post intervention
  description: Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where "exposing others" is defined as exposing others to one of the negative acts "more than once a week".
  measure: Change in number of children exposed by other children to negative behavior 1 and 2 years after the intervention
  time frame: 1 and 2 year post intervention
  description: Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score "being exposed" is defined as being exposing by others to one of the negative acts "more than once a week".
  measure: Change in child prosocial bystander behavior
  time frame: Pre- to post-intervention, 9 months and 1 and 2 years post intervention
  description: 12 item questionnaire, Alsaker 2004
  measure: Change in Authoritative climate
  time frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
  description: 10 item scale, adjusted from Ertesvåg, 2011
  measure: Change in personnel self-efficacy beliefs
  time frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
  description: 5 item scale, adjusted from Fischer, 2019
  measure: Change in personnel understanding of bullying among children in kindergartens
  time frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
  description: 8 items questionnaire
  arm group label: Be-Prox intervention
  arm group type: Experimental
  description: Training in the 6 Be-Prox module
  arm group label: Control
  arm group type: No Intervention
  description: Standard care
  intervention type: Behavioral
  intervention name: Be-Prox
  description: Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.
  arm group label: Be-Prox intervention
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ingrid Kvestad, Dr
  role: Principal Investigator
  affiliation: NORCE Norwegian Research Center
  last name: Ingrid Kvestad, Dr
  phone: +4799400431
  email: inkv@norceresearch.no
  last name: Merete Aasheim, Dr.
  phone: +47 99 26 46 30
  email: merete.aasheim@uit.no
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  country: Norway
  responsible party type: Sponsor
  mesh term: Bullying