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/NCT06001554</url>
    </required_header>
    <id_info>
      <org_study_id>ICC-T CRCT Pakistan</org_study_id>
      <nct_id>NCT06001554</nct_id>
    </id_info>
    <brief_title>Preventing Physical and Emotional Violence by Teachers in Public Schools in Pakistan</brief_title>
    <acronym>ICC-T_Pak</acronym>
    <official_title>Improving Adolescent Student Mental Health and Quality of Life Through a Reduction in Physical and Emotional Violence by Teachers in Pakistan: A Cluster Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bielefeld University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shifa Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shifa International Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mclean Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Konstanz</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Bielefeld University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Violence has severe and long-lasting negative consequences for children and adolescents'&#xD;
        well-being and psychosocial functioning, thereby also hampering communities and societies'&#xD;
        economic growth. Studies show high prevalence rates of violence by teachers against children&#xD;
        in Pakistan. In addition to legal and structural factors (e. g. stressful working conditions&#xD;
        for teachers), attitudes favoring violence against children as an effective and acceptable&#xD;
        discipline method and the lack of access to alternative non-violent strategies are likely to&#xD;
        contribute to teachers' ongoing use of violence against children.&#xD;
  &#xD;
        Notwithstanding, there are currently very few school-level interventions to reduce violence&#xD;
        by teachers that a) have been scientifically evaluated and b) that focus both on changing&#xD;
        attitudes towards violence and on equipping teachers with non-violent discipline strategies.&#xD;
  &#xD;
        Thus, the present study tests the effectiveness of the preventative intervention Interaction&#xD;
        Competencies with Children - for Teachers (ICC-T) in secondary schools in Pakistan. Previous&#xD;
        studies have provided initial evidence on the feasibility to implement teacher violence&#xD;
        interventions in secondary schools in Pakistan. This study aims to provide first evidence for&#xD;
        the effectiveness of ICC-T to reduce violence and to improve children's functioning (i.e.&#xD;
        mental health, well-being, academic performance) in Pakistan.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a multi-site cluster randomized controlled trial with schools (clusters) as&#xD;
        level of randomization. Three districts in each site of the four sites (Khyber Pakhtunkhwa&#xD;
        province, Sindh province, the State of Azad Jammu &amp; Kashmir, and the federal capital&#xD;
        Islamabad+Punjab province) will be purposely selected to ensure diversity of schools in terms&#xD;
        of geographical, economical, social, and politically background. In each site, 12 public&#xD;
        schools will be randomly selected, resulting in a total number of 48 schools (12 per sites).&#xD;
        Schools will be stratified based on school type (girls or boys school). In each site, 6&#xD;
        schools (3 girls and 3 boys schools) will be randomly allocated to the intervention group&#xD;
        (that will receive the ICC-T intervention) and the control group (that will receive no&#xD;
        intervention).&#xD;
  &#xD;
        At each school, 30 students in the first year of secondary and all teachers (expected average&#xD;
        number: 15) will be recruited. Thus the final sample will comprise 1440 students and at least&#xD;
        720 teachers at baseline.&#xD;
  &#xD;
        The study will have three data assessment points: baseline assessment prior to the&#xD;
        intervention, the first follow-up assessment six months after the intervention and the second&#xD;
        follow-up assessment 18 months after the intervention. In addition, feasibility data will be&#xD;
        assessed in the intervention group at the beginning and the end of the intervention.&#xD;
  &#xD;
        Primary outcome measures are student- and teacher-reported physical and emotional violence by&#xD;
        teachers in the past week. Secondary outcome measures include children's emotional and&#xD;
        behavioral problems, quality of life, cognitive functioning, academic performance, and school&#xD;
        attendance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of students' exposure to emotional and physical violence by teachers</measure>
      <time_frame>The CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>The Conflict Tactics Scale (CTS) will be used to assess students' self-reported experiences of emotional and physical violence by teachers at school in the past week. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger reduction of exposure to violence in the intervention group compared to the control group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change of teachers' use of emotional and physical violence</measure>
      <time_frame>The CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>The Conflict Tactics Scale (CTS) will be used to assess teachers' use of emotional and physical violent discipline measures against students in the past week. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger reduction of the use of violence in the intervention group compared to the control group.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of teachers' positive attitudes towards emotional and physical violence</measure>
      <time_frame>The adapted version of CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after the intervention)</time_frame>
      <description>Teacher's attitudes towards emotional and physical violence will be assessed with an adapted version of the Conflict Tactic Scale (CTS). Higher scores indicate higher levels of positive attitudes towards violence. We hypothesize a stronger decrease of positive attitudes towards violence in the intervention group compared to the control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of student's mental health</measure>
      <time_frame>The PSC-Y will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>The Pediatric Symptom Checklist - Youth Report (PSC-Y) will assess students' emotional and behavioral problems.&#xD;
  Higher scores indicate higher levels of students' mental health problems. We hypothesize a stronger reduction of mental health problems in the intervention group compared to the control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of students' quality of life</measure>
      <time_frame>The KIDSCREEN-10 will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>The KIDSCREEN-10 will assess students' quality of life. Higher scores indicate higher levels of students' quality of life.&#xD;
  We hypothesize an overall improvement of in the quality of life in the intervention group compared to the control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of students' cognitive functioning</measure>
      <time_frame>The app-based tasks will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>Five tasks from the tablet application Inquisit will be used to assess children's cognitive abilities including selective attention (Letter Cancellation Task), working memory (Corsi Block Tapping Backwards), response inhibition (Arrow Flanker Task), planning and problem solving (Tower of London) and cognitive flexibility (Wisconsin Card Sorting Test). The test results in each test will be z-standardized and then combined to one compound score. Higher scores indicate higher levels of students' cognitive abilities. We hypothesize higher levels of cognitive functioning in the intervention group compared to the control group.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change of students' academic performance</measure>
      <time_frame>Students' grades will be collected at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention).</time_frame>
      <description>Students' grades in the previous term's exams will be obtained from the school administration. An improvement in academic performance in the intervention group is hypothesized.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change of peer violence</measure>
      <time_frame>he Multidimensional Peer Victimization Scale will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)</time_frame>
      <description>The Multidimensional Peer Victimization Scale will be used assess students' experiences of violence by peers. Higher scores indicate higher levels of students' experiences of peer violence. We hypothesize a stronger decrease of peer violence in the intervention group compared to the control group.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2100</enrollment>
    <condition>Violence</condition>
    <arm_group>
      <arm_group_label>ICC-T</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 days with 8 hours of training for teachers. Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting</description>
    </arm_group>
    <arm_group>
      <arm_group_label>monitoring condition</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Interaction Competencies with Children - for Teachers (ICC-T)</intervention_name>
      <description>Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting</description>
      <arm_group_label>ICC-T</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          General:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          All: Written informed consent (if underaged by parents (written) &amp; minors themselves&#xD;
          (written) Students: Enrollment in selected secondary school Teachers: All teachers employed&#xD;
          at the selected schools&#xD;
  &#xD;
          Schools:&#xD;
  &#xD;
          Public secondary schools Day schools At least 30 students in selected class/stream&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          Students and teachers:&#xD;
  &#xD;
          Acute drug or alcohol intoxication Acute psychotic disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>62 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alaptagin Khan, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>McLean Hopstial</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tobias Hecker, PhD</last_name>
      <phone>+49 521 106 3105</phone>
      <email>tobias.hecker@uni-bielefeld.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alaptagin Khan, MBBS</last_name>
      <phone>+1 617 855 2096</phone>
      <email>AKHAN@MCLEAN.HARVARD.EDU</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shifa International Hospitals</name>
        <address>
          <city>Islamabad</city>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Abdul Wahab Yousafzai, MBBS</last_name>
        <email>wahab.yousafzai@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>school violence</keyword>
    <keyword>teacher violence</keyword>
    <keyword>teachers</keyword>
    <keyword>intervention</keyword>
    <keyword>students</keyword>
    <keyword>public schools</keyword>
    <keyword>secondary schools</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The ICC-T intervention is being tested in various other countries including Haiti, Ghana, Tanzania and Uganda. We will share anonymized data with project partners from the different countries for combined and/or comparative analyses. In addition, we will share anonymized data with other researchers working on prevention of violence against children in school settings for the purpose of conducting synthesizing analyses such as meta-analyses.&#xD;
  Finally, the anonymized data collected in the study will be made publicly available in a data repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The anonymized data will be made publicly available after completion of the project in 2027</ipd_time_frame>
      <ipd_access_criteria>During the project, anonymized data will be shared only with partners working in other ICC-T projects and other researchers working in prevention of violence against children upon request. After the completion of the project, the anonymized data will be available to the public.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06001554
  org study id: ICC-T CRCT Pakistan
  nct id: NCT06001554
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Violence has severe and long-lasting negative consequences for children and adolescents'
        well-being and psychosocial functioning, thereby also hampering communities and societies'
        economic growth. Studies show high prevalence rates of violence by teachers against children
        in Pakistan. In addition to legal and structural factors (e. g. stressful working conditions
        for teachers), attitudes favoring violence against children as an effective and acceptable
        discipline method and the lack of access to alternative non-violent strategies are likely to
        contribute to teachers' ongoing use of violence against children.
  
        Notwithstanding, there are currently very few school-level interventions to reduce violence
        by teachers that a) have been scientifically evaluated and b) that focus both on changing
        attitudes towards violence and on equipping teachers with non-violent discipline strategies.
  
        Thus, the present study tests the effectiveness of the preventative intervention Interaction
        Competencies with Children - for Teachers (ICC-T) in secondary schools in Pakistan. Previous
        studies have provided initial evidence on the feasibility to implement teacher violence
        interventions in secondary schools in Pakistan. This study aims to provide first evidence for
        the effectiveness of ICC-T to reduce violence and to improve children's functioning (i.e.
        mental health, well-being, academic performance) in Pakistan.
  The study is a multi-site cluster randomized controlled trial with schools (clusters) as
        level of randomization. Three districts in each site of the four sites (Khyber Pakhtunkhwa
        province, Sindh province, the State of Azad Jammu & Kashmir, and the federal capital
        Islamabad+Punjab province) will be purposely selected to ensure diversity of schools in terms
        of geographical, economical, social, and politically background. In each site, 12 public
        schools will be randomly selected, resulting in a total number of 48 schools (12 per sites).
        Schools will be stratified based on school type (girls or boys school). In each site, 6
        schools (3 girls and 3 boys schools) will be randomly allocated to the intervention group
        (that will receive the ICC-T intervention) and the control group (that will receive no
        intervention).
  
        At each school, 30 students in the first year of secondary and all teachers (expected average
        number: 15) will be recruited. Thus the final sample will comprise 1440 students and at least
        720 teachers at baseline.
  
        The study will have three data assessment points: baseline assessment prior to the
        intervention, the first follow-up assessment six months after the intervention and the second
        follow-up assessment 18 months after the intervention. In addition, feasibility data will be
        assessed in the intervention group at the beginning and the end of the intervention.
  
        Primary outcome measures are student- and teacher-reported physical and emotional violence by
        teachers in the past week. Secondary outcome measures include children's emotional and
        behavioral problems, quality of life, cognitive functioning, academic performance, and school
        attendance.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Change of students' exposure to emotional and physical violence by teachers
  time frame: The CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: The Conflict Tactics Scale (CTS) will be used to assess students' self-reported experiences of emotional and physical violence by teachers at school in the past week. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger reduction of exposure to violence in the intervention group compared to the control group.
  measure: Change of teachers' use of emotional and physical violence
  time frame: The CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: The Conflict Tactics Scale (CTS) will be used to assess teachers' use of emotional and physical violent discipline measures against students in the past week. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger reduction of the use of violence in the intervention group compared to the control group.
  measure: Change of teachers' positive attitudes towards emotional and physical violence
  time frame: The adapted version of CTS will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after the intervention)
  description: Teacher's attitudes towards emotional and physical violence will be assessed with an adapted version of the Conflict Tactic Scale (CTS). Higher scores indicate higher levels of positive attitudes towards violence. We hypothesize a stronger decrease of positive attitudes towards violence in the intervention group compared to the control group.
  measure: Change of student's mental health
  time frame: The PSC-Y will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: The Pediatric Symptom Checklist - Youth Report (PSC-Y) will assess students' emotional and behavioral problems.
  Higher scores indicate higher levels of students' mental health problems. We hypothesize a stronger reduction of mental health problems in the intervention group compared to the control group.
  measure: Change of students' quality of life
  time frame: The KIDSCREEN-10 will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: The KIDSCREEN-10 will assess students' quality of life. Higher scores indicate higher levels of students' quality of life.
  We hypothesize an overall improvement of in the quality of life in the intervention group compared to the control group.
  measure: Change of students' cognitive functioning
  time frame: The app-based tasks will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: Five tasks from the tablet application Inquisit will be used to assess children's cognitive abilities including selective attention (Letter Cancellation Task), working memory (Corsi Block Tapping Backwards), response inhibition (Arrow Flanker Task), planning and problem solving (Tower of London) and cognitive flexibility (Wisconsin Card Sorting Test). The test results in each test will be z-standardized and then combined to one compound score. Higher scores indicate higher levels of students' cognitive abilities. We hypothesize higher levels of cognitive functioning in the intervention group compared to the control group.
  measure: Change of students' academic performance
  time frame: Students' grades will be collected at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention).
  description: Students' grades in the previous term's exams will be obtained from the school administration. An improvement in academic performance in the intervention group is hypothesized.
  measure: Change of peer violence
  time frame: he Multidimensional Peer Victimization Scale will be used at T0 (baseline, prior to intervention), T1 (first follow-up, 6 months after intervention) and T2 (second follow-up, 18 months after intervention)
  description: The Multidimensional Peer Victimization Scale will be used assess students' experiences of violence by peers. Higher scores indicate higher levels of students' experiences of peer violence. We hypothesize a stronger decrease of peer violence in the intervention group compared to the control group.
  arm group label: ICC-T
  arm group type: Experimental
  description: 5 days with 8 hours of training for teachers. Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting
  arm group label: monitoring condition
  arm group type: No Intervention
  description: No intervention
  intervention type: Behavioral
  intervention name: Interaction Competencies with Children - for Teachers (ICC-T)
  description: Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting
  arm group label: ICC-T
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 62 Years
  healthy volunteers: No
  last name: Alaptagin Khan, MBBS
  role: Principal Investigator
  affiliation: McLean Hopstial
  last name: Tobias Hecker, PhD
  phone: +49 521 106 3105
  email: tobias.hecker@uni-bielefeld.de
  last name: Alaptagin Khan, MBBS
  phone: +1 617 855 2096
  email: AKHAN@MCLEAN.HARVARD.EDU
  facility: 
  contact: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: The ICC-T intervention is being tested in various other countries including Haiti, Ghana, Tanzania and Uganda. We will share anonymized data with project partners from the different countries for combined and/or comparative analyses. In addition, we will share anonymized data with other researchers working on prevention of violence against children in school settings for the purpose of conducting synthesizing analyses such as meta-analyses.
  Finally, the anonymized data collected in the study will be made publicly available in a data repository.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The anonymized data will be made publicly available after completion of the project in 2027
  ipd access criteria: During the project, anonymized data will be shared only with partners working in other ICC-T projects and other researchers working in prevention of violence against children upon request. After the completion of the project, the anonymized data will be available to the public.