<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/NCT01678846</url>
  </required_header>
  <id_info>
    <org_study_id>LSHTM_6183</org_study_id>
    <nct_id>NCT01678846</nct_id>
  </id_info>
  <brief_title>Good Schools Study</brief_title>
  <acronym>GSS</acronym>
  <official_title>The Good Schools Study: Cluster Randomised Controlled Trial of a Program to Prevent Violence Against Children in Schools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Raising Voices</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Education, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether use of the Good Schools Toolkit is&#xD;
      effective in reducing violence against children in primary schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Violence against children has profound effects on both children's health and their ability to&#xD;
      do well at school. Fear, anxiety and injuries caused by violence may play a large role in&#xD;
      both children's absenteeism and low educational achievement, and there is increasing interest&#xD;
      from large bilateral donors in investigating this link in low income countries. The Good&#xD;
      School Toolkit has been developed and refined for 6 years in Uganda by Raising Voices. The&#xD;
      toolkit takes a systemic approach, involving an entire school in a process of change to&#xD;
      reduce violence and improve teaching techniques. The Toolkit draws on the Transtheoretical&#xD;
      Model and incorporates standard behaviour change techniques such as setting a goal and making&#xD;
      an action plan, which are effective in modifying behaviour. This study aims to determine&#xD;
      whether use of the Good School Toolkit reduces children's experience of violence by school&#xD;
      staff. The investigators will also examine the effects of the Toolkit on children's&#xD;
      educational outcomes, mental health and well-being.&#xD;
&#xD;
      The investigators will conduct a cluster randomised controlled trial in 40 primary schools in&#xD;
      Luwero District, Uganda. More than 3500 children in Primary 5, 6 and 7 will be surveyed (aged&#xD;
      about 11-16 years). Half of the schools will receive the Toolkit, and other half will be put&#xD;
      on a waiting list to receive the Toolkit at the end of the study. The results from this&#xD;
      evaluation will be used to brief policy-makers within the Ministry of Education and Sports&#xD;
      involved in developing country-wide policy and practice around violence against children in&#xD;
      schools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Physical Violence From School Staff</measure>
    <time_frame>2-year follow-up</time_frame>
    <description>past week experience of any physical violence from school staff</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Mental Health</measure>
    <time_frame>2-year follow-up</time_frame>
    <description>score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educational Achievement: Word Recognition in English</measure>
    <time_frame>2-year follow-up</time_frame>
    <description>Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Well-being at School</measure>
    <time_frame>At 2 year follow-up</time_frame>
    <description>Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:&#xD;
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3820</enrollment>
  <condition>Physical Violence</condition>
  <condition>Educational Achievement</condition>
  <condition>Mental Health</condition>
  <condition>Sexual Violence</condition>
  <condition>Violence Against Children</condition>
  <arm_group>
    <arm_group_label>Good School Toolkit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Good School Toolkit</intervention_name>
    <description>The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
    <arm_group_label>Good School Toolkit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
               -  Schools&#xD;
&#xD;
                    -  in Luwero District, Uganda&#xD;
&#xD;
                    -  more than 40 students registered in Primary 5&#xD;
&#xD;
               -  Participants&#xD;
&#xD;
                    -  registered as a Primary 5, 6 or 7 pupil&#xD;
&#xD;
                    -  any school staff member&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               -  Schools&#xD;
&#xD;
                  -- existing program related to prevention of violence against children or school&#xD;
                  governance&#xD;
&#xD;
               -  Participants -- not able to understand consent and study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen M Devries, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LSHTM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>District-wide</name>
      <address>
        <city>Multiple</city>
        <state>Luwero District</state>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>October 8, 2015</results_first_submitted>
  <results_first_submitted_qc>December 17, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 26, 2016</results_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corporal punishment</keyword>
  <keyword>violence</keyword>
  <keyword>education</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>conduct disorder</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Cross-sectional baseline and endline surveys were conducted in 42 schools in June/July 2012 and June/July 2014. A simple random sample of up to 130 P5, 6 and 7 students were invited for individual interviews. If there were fewer than 130 P5-7 students in a school, all were invited for interview.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Good School Toolkit</title>
          <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1921">Whole school implementation. Started and completed shows number of students in the end-line survey.</participants>
                <participants group_id="P2" count="1899"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1921"/>
                <participants group_id="P2" count="1899"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline survey total participants is shown here (whereas the number in the participant flow is the number of participants at endline, in both the &quot;started and &quot;completed&quot;)</population>
      <group_list>
        <group group_id="B1">
          <title>Good School Toolkit</title>
          <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1824"/>
            <count group_id="B2" value="1882"/>
            <count group_id="B3" value="3706"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="1.5"/>
                    <measurement group_id="B2" value="13.0" spread="1.5"/>
                    <measurement group_id="B3" value="13.0" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="927"/>
                    <measurement group_id="B2" value="1010"/>
                    <measurement group_id="B3" value="1937"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="897"/>
                    <measurement group_id="B2" value="872"/>
                    <measurement group_id="B3" value="1769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physical Violence From School Staff</title>
        <description>past week experience of any physical violence from school staff</description>
        <time_frame>2-year follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Good School Toolkit</title>
            <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Violence From School Staff</title>
          <description>past week experience of any physical violence from school staff</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1921"/>
                <count group_id="O2" value="1899"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="595"/>
                    <measurement group_id="O2" value="924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
            <estimate_desc>An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Mental Health</title>
        <description>score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).</description>
        <time_frame>2-year follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Good School Toolkit</title>
            <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Mental Health</title>
          <description>score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1921"/>
                <count group_id="O2" value="1899"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="0.26"/>
                    <measurement group_id="O2" value="0.44" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Educational Achievement: Word Recognition in English</title>
        <description>Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).</description>
        <time_frame>2-year follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Good School Toolkit</title>
            <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Educational Achievement: Word Recognition in English</title>
          <description>Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).</description>
          <units>words per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1921"/>
                <count group_id="O2" value="1899"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6" spread="27.7"/>
                    <measurement group_id="O2" value="49.7" spread="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Well-being at School</title>
        <description>Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:&#xD;
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school.</description>
        <time_frame>At 2 year follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Good School Toolkit</title>
            <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Well-being at School</title>
          <description>Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:&#xD;
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1921"/>
                <count group_id="O2" value="1899"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="2.4"/>
                    <measurement group_id="O2" value="11.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Good School Toolkit</title>
          <description>Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.&#xD;
Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1921"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1899"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1921"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1899"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Karen Devries</name_or_title>
      <organization>London School of Hygiene and Tropical Medicine</organization>
      <phone>0207958 8164 ext 8164</phone>
      <email>Karen.Devries@lshtm.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01678846
org study id: LSHTM_6183
nct id: NCT01678846
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether use of the Good Schools Toolkit is
      effective in reducing violence against children in primary schools.
Violence against children has profound effects on both children's health and their ability to
      do well at school. Fear, anxiety and injuries caused by violence may play a large role in
      both children's absenteeism and low educational achievement, and there is increasing interest
      from large bilateral donors in investigating this link in low income countries. The Good
      School Toolkit has been developed and refined for 6 years in Uganda by Raising Voices. The
      toolkit takes a systemic approach, involving an entire school in a process of change to
      reduce violence and improve teaching techniques. The Toolkit draws on the Transtheoretical
      Model and incorporates standard behaviour change techniques such as setting a goal and making
      an action plan, which are effective in modifying behaviour. This study aims to determine
      whether use of the Good School Toolkit reduces children's experience of violence by school
      staff. The investigators will also examine the effects of the Toolkit on children's
      educational outcomes, mental health and well-being.

      The investigators will conduct a cluster randomised controlled trial in 40 primary schools in
      Luwero District, Uganda. More than 3500 children in Primary 5, 6 and 7 will be surveyed (aged
      about 11-16 years). Half of the schools will receive the Toolkit, and other half will be put
      on a waiting list to receive the Toolkit at the end of the study. The results from this
      evaluation will be used to brief policy-makers within the Ministry of Education and Sports
      involved in developing country-wide policy and practice around violence against children in
      schools.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical Violence From School Staff
time frame: 2-year follow-up
description: past week experience of any physical violence from school staff
measure: Child Mental Health
time frame: 2-year follow-up
description: score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).
measure: Educational Achievement: Word Recognition in English
time frame: 2-year follow-up
description: Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).
measure: Safety and Well-being at School
time frame: At 2 year follow-up
description: Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school.
arm group label: Good School Toolkit
arm group type: Experimental
description: Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.
arm group label: Control
arm group type: No Intervention
description: Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
intervention type: Behavioral
intervention name: Good School Toolkit
description: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).
arm group label: Good School Toolkit
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Karen M Devries, PhD
role: Principal Investigator
affiliation: LSHTM
facility: 
country: Uganda
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 