<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/NCT03783767</url>
  </required_header>
  <id_info>
    <org_study_id>H18-00141</org_study_id>
    <nct_id>NCT03783767</nct_id>
  </id_info>
  <brief_title>Peer Leadership for Physical Literacy</brief_title>
  <acronym>PLPL</acronym>
  <official_title>Peer Leadership for Physical Literacy: A Randomized Controlled Trial for Elementary School Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Social Sciences and Humanities Research Council of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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>
      The purpose of the proposed research is to develop, implement, and test the efficacy of a&#xD;
      theory-driven evidence-based peer leadership program for elementary school students (Grade&#xD;
      6/7; age 11/12 years) in relation to (a) their own leadership skills and their leadership&#xD;
      self-efficacy (i.e., confidence to lead), as well as (b) the physical literacy of younger&#xD;
      (Grade 3/4; age 8/9) students with whom they are partnered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Teacher's rating of their student's transformational leadership using the Transformational Teaching Questionnaire</measure>
    <time_frame>Change from Baseline Transformational Leadership at 6 months (Post Intervention)</time_frame>
    <description>Transformational leadership by Grade 6/7 peer leaders will be assessed by teachers using an adaption version of the Transformational Teaching Questionnaire (Beauchamp et al., 2010). This abbreviated measures has been used in our previous studies which demonstrated sound reliability (cronbach alpha &gt; 0.89).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-Rated Leadership Self-Efficacy using a ten-item questionnaire</measure>
    <time_frame>Change from Baseline Leadership Self-Efficacy at 6 months (Post Intervention)</time_frame>
    <description>Leadership Self-Efficacy by Grade 6/7 peer leaders will be assessed using a ten-item leadership self-efficacy measure using Bandura's (2006) recommended procedures for assessing self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade 3/4 student self reported intrinsic motivation using the Intrinsic motivation measure by Sebire and colleagues (2013)</measure>
    <time_frame>Change from Baseline Intrinsic Motivation at 6 months (Post Intervention)</time_frame>
    <description>Intrinsic motivation among Grade 3/4 students will be assessed using the Intrinsic Motivation measure developed by Sebire and colleagues (2013) for specific use with young children in school physical education settings. This measure displays sound reliability (cronbach alpha = 0.77), as well as factorial validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade 3/4 self-reported Perceived Competence using the Perceived Competence measure developed by Sebire and colleagues (2013)</measure>
    <time_frame>Change from Baseline Intrinsic Motivation at 6 months (Post Intervention)</time_frame>
    <description>Grade 3/4 Perceived Competence will be measured by a questionnaire developed by Sebire and colleagues (2013) for specific use in school physical education settings with young children. This measure has been shown to display sound reliability (cronbach alpha = 0.72).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Self Description Questionnaire (Marsh et al., 2010) will assess Grade 3/4 self-reported self-concept</measure>
    <time_frame>Change from Baseline Self-Concept at 6 months (Post Intervention)</time_frame>
    <description>The Physical Self Description Questionnaire is a self-report measure for Grade 3/4 students that has sound reliability and factorial validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fundamental Movement Skills Competence assessed via the Test of Gross Motor Development (3rd edition) and product scores (throw/kick speed, successful number of catches)</measure>
    <time_frame>Change from Baseline Fundamental Movement Skills at 6 months (Post Intervention)</time_frame>
    <description>The kick, throw and a combination throwing/catching test will be performed. Skills will be videoed so that raters can assess the process of each movement and score according to predefined criteria of the Test of Gross Motor Development 3rd edition (Ulrich and Webster, 2017). Our assessment will also enable us to assess maximal kicking and throwing speed. The combination throwing/catching test will be performed for two trials of 30 seconds each, with scores assigned based on the number of successful catches each participant completes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Day Physical Activity will be assessed in Grade 3/4 students using hip worn GT3X+ accelerometers</measure>
    <time_frame>Change from Baseline School Day Physical Activity at 6 Months (Post Intervention)</time_frame>
    <description>A subsample of Grade 3/4 students will be randomly selected to wear an accelerometer for one school week (5 days) during the school day only.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">359</enrollment>
  <condition>Leadership</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Leadership Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teachers in the intervention group will receive a half day workshop from a member of the research team. These teachers will then provide a four week training program to Grade 6/7 students, who will then deliver a 10-week fundamental movement skill (FMS) training program to Grade 3/4 students.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of students and teachers will act as a waitlist control group. Therefore, during the same time that the other group is receiving the intervention, this group will proceed with their normal practices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Leadership Intervention</intervention_name>
    <description>Grade 6/7 teachers will take part in a workshop on developing transformational leadership among their Grade 6/7 students, and provide teachers with a 4-week training program. Teachers will implement a 4-week leadership development component to their Grade 6/7 students. Grade 6/7 students will then deliver a 10-week peer-led FMS program to Grade 3/4 students. The Grade 6/7 peer leaders will lead 2 x 30 min sessions per week during physical education classes, recess, or lunch times. In weeks two and three, peer leaders will be observed by members of the research team and provided with feedback using a structured checklist regarding their delivery in the session. Mid-way through the 10-week program teachers will deliver a booster leadership training component to the Grade 6/7 peer-leaders.</description>
    <arm_group_label>Leadership Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be teachers (Grade 6/7) and students (Grade 3,4, 6 or 7) in&#xD;
             elementary schools in the Lower Mainland of British Columbia.&#xD;
&#xD;
          -  Students must have a basic working knowledge of English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria that would exclude anyone who otherwise meets the&#xD;
             inclusion criteria specified above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark R Beauchamp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychology of Exercise, Health, and Physical Activity Laboratory</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Nathan N, Sutherland R, Beauchamp MR, Cohen K, Hulteen RM, Babic M, Wolfenden L, Lubans DR. Feasibility and efficacy of the Great Leaders Active StudentS (GLASS) program on children's physical activity and object control skill competency: A non-randomised trial. J Sci Med Sport. 2017 Dec;20(12):1081-1086. doi: 10.1016/j.jsams.2017.04.016. Epub 2017 Apr 21.</citation>
    <PMID>28487140</PMID>
  </reference>
  <reference>
    <citation>Beauchamp MR, Barling J, Li Z, Morton KL, Keith SE, Zumbo BD. Development and psychometric properties of the transformational teaching questionnaire. J Health Psychol. 2010 Nov;15(8):1123-34. doi: 10.1177/1359105310364175. Epub 2010 Jun 3.</citation>
    <PMID>20522503</PMID>
  </reference>
  <reference>
    <citation>Sebire SJ, Jago R, Fox KR, Edwards MJ, Thompson JL. Testing a self-determination theory model of children's physical activity motivation: a cross-sectional study. Int J Behav Nutr Phys Act. 2013 Sep 26;10:111. doi: 10.1186/1479-5868-10-111.</citation>
    <PMID>24067078</PMID>
  </reference>
  <reference>
    <citation>Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.</citation>
    <PMID>20733208</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Mark Beauchamp</investigator_full_name>
    <investigator_title>Professor of Kinesiology</investigator_title>
  </responsible_party>
  <keyword>school</keyword>
  <keyword>intervention</keyword>
  <keyword>physical literacy</keyword>
  <keyword>peer mentor</keyword>
  <keyword>leadership</keyword>
  <keyword>motor skills</keyword>
  <keyword>physical activity</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03783767/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03783767
org study id: H18-00141
nct id: NCT03783767
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed research is to develop, implement, and test the efficacy of a
      theory-driven evidence-based peer leadership program for elementary school students (Grade
      6/7; age 11/12 years) in relation to (a) their own leadership skills and their leadership
      self-efficacy (i.e., confidence to lead), as well as (b) the physical literacy of younger
      (Grade 3/4; age 8/9) students with whom they are partnered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Teacher's rating of their student's transformational leadership using the Transformational Teaching Questionnaire
time frame: Change from Baseline Transformational Leadership at 6 months (Post Intervention)
description: Transformational leadership by Grade 6/7 peer leaders will be assessed by teachers using an adaption version of the Transformational Teaching Questionnaire (Beauchamp et al., 2010). This abbreviated measures has been used in our previous studies which demonstrated sound reliability (cronbach alpha > 0.89).
measure: Self-Rated Leadership Self-Efficacy using a ten-item questionnaire
time frame: Change from Baseline Leadership Self-Efficacy at 6 months (Post Intervention)
description: Leadership Self-Efficacy by Grade 6/7 peer leaders will be assessed using a ten-item leadership self-efficacy measure using Bandura's (2006) recommended procedures for assessing self-efficacy.
measure: Grade 3/4 student self reported intrinsic motivation using the Intrinsic motivation measure by Sebire and colleagues (2013)
time frame: Change from Baseline Intrinsic Motivation at 6 months (Post Intervention)
description: Intrinsic motivation among Grade 3/4 students will be assessed using the Intrinsic Motivation measure developed by Sebire and colleagues (2013) for specific use with young children in school physical education settings. This measure displays sound reliability (cronbach alpha = 0.77), as well as factorial validity.
measure: Grade 3/4 self-reported Perceived Competence using the Perceived Competence measure developed by Sebire and colleagues (2013)
time frame: Change from Baseline Intrinsic Motivation at 6 months (Post Intervention)
description: Grade 3/4 Perceived Competence will be measured by a questionnaire developed by Sebire and colleagues (2013) for specific use in school physical education settings with young children. This measure has been shown to display sound reliability (cronbach alpha = 0.72).
measure: Physical Self Description Questionnaire (Marsh et al., 2010) will assess Grade 3/4 self-reported self-concept
time frame: Change from Baseline Self-Concept at 6 months (Post Intervention)
description: The Physical Self Description Questionnaire is a self-report measure for Grade 3/4 students that has sound reliability and factorial validity.
measure: Fundamental Movement Skills Competence assessed via the Test of Gross Motor Development (3rd edition) and product scores (throw/kick speed, successful number of catches)
time frame: Change from Baseline Fundamental Movement Skills at 6 months (Post Intervention)
description: The kick, throw and a combination throwing/catching test will be performed. Skills will be videoed so that raters can assess the process of each movement and score according to predefined criteria of the Test of Gross Motor Development 3rd edition (Ulrich and Webster, 2017). Our assessment will also enable us to assess maximal kicking and throwing speed. The combination throwing/catching test will be performed for two trials of 30 seconds each, with scores assigned based on the number of successful catches each participant completes.
measure: School Day Physical Activity will be assessed in Grade 3/4 students using hip worn GT3X+ accelerometers
time frame: Change from Baseline School Day Physical Activity at 6 Months (Post Intervention)
description: A subsample of Grade 3/4 students will be randomly selected to wear an accelerometer for one school week (5 days) during the school day only.
arm group label: Leadership Intervention Group
arm group type: Experimental
description: Teachers in the intervention group will receive a half day workshop from a member of the research team. These teachers will then provide a four week training program to Grade 6/7 students, who will then deliver a 10-week fundamental movement skill (FMS) training program to Grade 3/4 students.
arm group label: Waitlist Control
arm group type: No Intervention
description: This group of students and teachers will act as a waitlist control group. Therefore, during the same time that the other group is receiving the intervention, this group will proceed with their normal practices.
intervention type: Behavioral
intervention name: Leadership Intervention
description: Grade 6/7 teachers will take part in a workshop on developing transformational leadership among their Grade 6/7 students, and provide teachers with a 4-week training program. Teachers will implement a 4-week leadership development component to their Grade 6/7 students. Grade 6/7 students will then deliver a 10-week peer-led FMS program to Grade 3/4 students. The Grade 6/7 peer leaders will lead 2 x 30 min sessions per week during physical education classes, recess, or lunch times. In weeks two and three, peer leaders will be observed by members of the research team and provided with feedback using a structured checklist regarding their delivery in the session. Mid-way through the 10-week program teachers will deliver a booster leadership training component to the Grade 6/7 peer-leaders.
arm group label: Leadership Intervention Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark R Beauchamp, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
citation: Nathan N, Sutherland R, Beauchamp MR, Cohen K, Hulteen RM, Babic M, Wolfenden L, Lubans DR. Feasibility and efficacy of the Great Leaders Active StudentS (GLASS) program on children's physical activity and object control skill competency: A non-randomised trial. J Sci Med Sport. 2017 Dec;20(12):1081-1086. doi: 10.1016/j.jsams.2017.04.016. Epub 2017 Apr 21.
PMID: 28487140
citation: Beauchamp MR, Barling J, Li Z, Morton KL, Keith SE, Zumbo BD. Development and psychometric properties of the transformational teaching questionnaire. J Health Psychol. 2010 Nov;15(8):1123-34. doi: 10.1177/1359105310364175. Epub 2010 Jun 3.
PMID: 20522503
citation: Sebire SJ, Jago R, Fox KR, Edwards MJ, Thompson JL. Testing a self-determination theory model of children's physical activity motivation: a cross-sectional study. Int J Behav Nutr Phys Act. 2013 Sep 26;10:111. doi: 10.1186/1479-5868-10-111.
PMID: 24067078
citation: Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.
PMID: 20733208
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Mark Beauchamp
investigator title: Professor of Kinesiology
sharing ipd: Undecided
provided document: 