<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/NCT03039894</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#16-001059</org_study_id>
    <nct_id>NCT03039894</nct_id>
  </id_info>
  <brief_title>Grade Book Game Evaluation Among 6th Grade Students</brief_title>
  <acronym>GG</acronym>
  <official_title>Improving School Engagement Among Early Adolescents: Evaluation of a Team-based Social Network Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      School engagement is associated with children's long-term health and success. Students who&#xD;
      are engaged in school have better academic outcomes and lower rates of risky health&#xD;
      behaviors. The investigators partnered with Alliance College-Ready Middle Academy 12&#xD;
      (Alliance 12), a charter school in Los Angeles, to develop the &quot;gradebook game&quot;, an&#xD;
      intervention that aims to improve academic achievement, peer support, and school engagement.&#xD;
      The game involves frequent feedback on students' school performance, team-based competition&#xD;
      aligned with the school mission, and peer mentorship by team captains. For the 2016-2017&#xD;
      academic year, the investigators will assist Alliance 12 in implementing the gradebook game&#xD;
      in two of its five 6th grade homerooms. The investigators plan to evaluate whether the game,&#xD;
      as hypothesized, is effective in increasing school engagement, including academic performance&#xD;
      and positive behavior.&#xD;
&#xD;
      In order to conduct this evaluation, the investigators plan to enroll 6th grade students by&#xD;
      obtaining parental consent and student assent at the beginning of the school year. Students&#xD;
      will be enrolled for the entire 2016-2017 academic year. All study procedures except for&#xD;
      parental recruitment will occur during the school day. Participation in the study involves&#xD;
      completing 2 student surveys and permitting the collection and analysis of student data from&#xD;
      the online gradebook and behavior system. The investigators plan to use an interrupted time&#xD;
      series design that will analyze student gradebook and behavior data at multiple time points&#xD;
      before and after the game starts. The surveys will be completed at the beginning and end of&#xD;
      the study period. Surveys will include measures of self-reported school engagement, age,&#xD;
      gender, race/ethnicity, primary language at home, social and emotional well-being, social&#xD;
      status, and peer support. Surveys will be administered via iPad.&#xD;
&#xD;
      If the pilot study demonstrates that the gradebook game is effective in promoting school&#xD;
      engagement and academic achievement, it is anticipated that it could be widely adopted and&#xD;
      more rigorously evaluated in a larger study. Because the gradebook game is a low-resource&#xD;
      intervention, it could easily and sustainably be replicated, providing a much-needed tool for&#xD;
      schools with low engagement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      School engagement is critical to students' long-term success and appears to be strongly&#xD;
      influenced by peer relationships. School engagement results from the interaction of the&#xD;
      individual with the school context and is a multi-dimensional concept involving behavioral,&#xD;
      emotional, and cognitive components. These include attendance, conduct, effort,&#xD;
      participation, emotions towards school, identification with school, interest, and&#xD;
      psychological investment in learning. Children who are engaged in school have higher levels&#xD;
      of academic achievement and increased likelihood of occupational success as adults, even&#xD;
      beyond that predicted by achievement. Children who are successful in school are also&#xD;
      healthier adults, which is due in part to health risk behaviors that begin in adolescence.&#xD;
      School engagement appears to protect against substance use and delinquency. Factors that have&#xD;
      been associated with low levels of engagement (or disengagement) include trauma, stress,&#xD;
      discrimination, and bullying, whereas supportive relationships with parents, peers, and&#xD;
      teachers promote school engagement. Because school engagement is modifiable, it is an obvious&#xD;
      target for school-based intervention.&#xD;
&#xD;
      Prior studies have documented interventions that improve school engagement, but effect sizes&#xD;
      are generally small and they are resource-intensive and therefore difficult to implement&#xD;
      widely. As far as the investigators know, none have used a social network or team-based&#xD;
      behavioral economics approach. A partnership between UCLA and Alliance College-Ready Middle&#xD;
      Academy #12 (Alliance 12), a charter middle school in Los Angeles led to the development of&#xD;
      the novel Gradebook Game. This intervention aims to induce supportive social pressure aligned&#xD;
      with a school's mission in order to promote school engagement and achievement. Sixth grade&#xD;
      students are organized into teams by Advisory period and mentored by 8th grade team captains.&#xD;
      Throughout the regular school day, students are assigned points for effort, achievement, and&#xD;
      citizenship (as captured by the online gradebook and behavior tracker), which then get&#xD;
      repackaged into weekly team scorecards for the Game. Teams compete against each other for&#xD;
      total points in bi-weekly match-ups, and wins are rewarded with incentives tailored to the&#xD;
      school's needs. This intervention is unique in bringing a team-based behavioral economics&#xD;
      approach to impact school engagement. It is grounded in principles from two successful&#xD;
      interventions: the Good Behavior Game and Peer Connection. The Gradebook Game Intervention&#xD;
      has been piloted for feasibility in one Advisory group of 6th grade students at Alliance 12&#xD;
      during the Spring of 2016. If effective, it could feasibly be implemented widely and has the&#xD;
      potential to transform social norms and school culture, providing a much-needed tool among&#xD;
      schools with low student engagement.&#xD;
&#xD;
      The investigators plan to study the effectiveness of the Gradebook Game in promoting school&#xD;
      engagement and achievement. This study would likely be the first to evaluate an intervention&#xD;
      that utilizes team competition to generate social pressure and peer support around behaviors&#xD;
      that promote success in school. This study has the potential to inform whether the Gradebook&#xD;
      Game intervention should be adopted by other schools struggling with low student engagement;&#xD;
      and depending on the results, it could lead to a larger, more rigorous study that would&#xD;
      evaluate whether the Gradebook Game is effective in promoting school engagement and&#xD;
      achievement among a diverse study population, which could be beneficial to schools and&#xD;
      families across the nation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Academic and Behavior Information</measure>
    <time_frame>up to 20 times during 6 month period</time_frame>
    <description>collect school grade book and behavior information weekly for 8 to 10 time points before and after the intervention is implemented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social Emotional well being, social status and peer support</measure>
    <time_frame>baseline and at 6 months</time_frame>
    <description>Survey data will be collected via iPad using a study ID during non-content periods at school (Advisory and Enrichment). Surveys will include measures of self-reported school engagement, social-emotional well-being, and peer support.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Adolescent Behaviors</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>The middle school selected 2 advisory classrooms to participate in the Gradebook game during 6th grade. Students in these 2 classrooms were block randomized to teams by baseline grade book and student engagement scores. These small student teams stay together for an entire year and meet once or twice a week. Teams are led by 8th grade student team captains, picked by school staff for their positive leadership skills. Every 2 weeks throughout the year, teams are randomly matched in head-to-head competition. In each 2-week-long game (i.e. Gradebook Game), individual team members accrue points from teachers and administrators for academic performance, effort, and school behavior. Team wins are announced and public scoreboards are updated frequently. The investigators will collect student survey data at baseline and after the intervention, approximately 5-6 months apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>The middle school has chosen three 6th grade classrooms that will not play the Gradebook game. The investigators will collect school gradebook and behavior information weekly for 8 to 10 time points before and after the intervention is implemented. Students will complete a survey at baseline and after the intervention, approximately 5-6 months apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gradebook Game</intervention_name>
    <description>Students in the intervention group will spend time meeting as teams to review their scorecards, and do team-building activities, all of which will occur during non-content periods at school (Advisory and Enrichment).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants must be 6th grade students at Alliance College-Ready Middle Academy. They need&#xD;
        to assent and have signed parental consent to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Student must be attending 6th grade at Alliance College-Ready Middle Academy.&#xD;
&#xD;
          -  Must assent and have signed parental consent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Students whose parents are not able to provide informed consent in English or Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mitchell D Wong, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>October 26, 2017</last_update_submitted>
  <last_update_submitted_qc>October 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Mitchell Wong, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine; Faculty Mentor</investigator_title>
  </responsible_party>
  <keyword>school-based, evaluation, interrupted time series</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participants have been assigned a study ID number to link their name, address, phone number, grade book and behavior data, and survey responses. This ID will be used for all survey data collection and to identify all grade book and behavior data.&#xD;
The computer file linking the personal identifiers and the study ID number will be kept separate from the survey, grade book, and behavior data. Personally identifying information pertaining to individual participants will not be shared or made available to other researchers. Any data request will be made to the Faculty Sponsor (Mitchell Wong, MD PhD) or to the principle investigator (Ashley Lewis-Hunter, MD) and any data shared will be encrypted and will not include any personal identifying information.</ipd_description>
  </patient_data>
  <!-- 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/NCT03039894
org study id: IRB#16-001059
nct id: NCT03039894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
School engagement is associated with children's long-term health and success. Students who
      are engaged in school have better academic outcomes and lower rates of risky health
      behaviors. The investigators partnered with Alliance College-Ready Middle Academy 12
      (Alliance 12), a charter school in Los Angeles, to develop the "gradebook game", an
      intervention that aims to improve academic achievement, peer support, and school engagement.
      The game involves frequent feedback on students' school performance, team-based competition
      aligned with the school mission, and peer mentorship by team captains. For the 2016-2017
      academic year, the investigators will assist Alliance 12 in implementing the gradebook game
      in two of its five 6th grade homerooms. The investigators plan to evaluate whether the game,
      as hypothesized, is effective in increasing school engagement, including academic performance
      and positive behavior.

      In order to conduct this evaluation, the investigators plan to enroll 6th grade students by
      obtaining parental consent and student assent at the beginning of the school year. Students
      will be enrolled for the entire 2016-2017 academic year. All study procedures except for
      parental recruitment will occur during the school day. Participation in the study involves
      completing 2 student surveys and permitting the collection and analysis of student data from
      the online gradebook and behavior system. The investigators plan to use an interrupted time
      series design that will analyze student gradebook and behavior data at multiple time points
      before and after the game starts. The surveys will be completed at the beginning and end of
      the study period. Surveys will include measures of self-reported school engagement, age,
      gender, race/ethnicity, primary language at home, social and emotional well-being, social
      status, and peer support. Surveys will be administered via iPad.

      If the pilot study demonstrates that the gradebook game is effective in promoting school
      engagement and academic achievement, it is anticipated that it could be widely adopted and
      more rigorously evaluated in a larger study. Because the gradebook game is a low-resource
      intervention, it could easily and sustainably be replicated, providing a much-needed tool for
      schools with low engagement.
School engagement is critical to students' long-term success and appears to be strongly
      influenced by peer relationships. School engagement results from the interaction of the
      individual with the school context and is a multi-dimensional concept involving behavioral,
      emotional, and cognitive components. These include attendance, conduct, effort,
      participation, emotions towards school, identification with school, interest, and
      psychological investment in learning. Children who are engaged in school have higher levels
      of academic achievement and increased likelihood of occupational success as adults, even
      beyond that predicted by achievement. Children who are successful in school are also
      healthier adults, which is due in part to health risk behaviors that begin in adolescence.
      School engagement appears to protect against substance use and delinquency. Factors that have
      been associated with low levels of engagement (or disengagement) include trauma, stress,
      discrimination, and bullying, whereas supportive relationships with parents, peers, and
      teachers promote school engagement. Because school engagement is modifiable, it is an obvious
      target for school-based intervention.

      Prior studies have documented interventions that improve school engagement, but effect sizes
      are generally small and they are resource-intensive and therefore difficult to implement
      widely. As far as the investigators know, none have used a social network or team-based
      behavioral economics approach. A partnership between UCLA and Alliance College-Ready Middle
      Academy #12 (Alliance 12), a charter middle school in Los Angeles led to the development of
      the novel Gradebook Game. This intervention aims to induce supportive social pressure aligned
      with a school's mission in order to promote school engagement and achievement. Sixth grade
      students are organized into teams by Advisory period and mentored by 8th grade team captains.
      Throughout the regular school day, students are assigned points for effort, achievement, and
      citizenship (as captured by the online gradebook and behavior tracker), which then get
      repackaged into weekly team scorecards for the Game. Teams compete against each other for
      total points in bi-weekly match-ups, and wins are rewarded with incentives tailored to the
      school's needs. This intervention is unique in bringing a team-based behavioral economics
      approach to impact school engagement. It is grounded in principles from two successful
      interventions: the Good Behavior Game and Peer Connection. The Gradebook Game Intervention
      has been piloted for feasibility in one Advisory group of 6th grade students at Alliance 12
      during the Spring of 2016. If effective, it could feasibly be implemented widely and has the
      potential to transform social norms and school culture, providing a much-needed tool among
      schools with low student engagement.

      The investigators plan to study the effectiveness of the Gradebook Game in promoting school
      engagement and achievement. This study would likely be the first to evaluate an intervention
      that utilizes team competition to generate social pressure and peer support around behaviors
      that promote success in school. This study has the potential to inform whether the Gradebook
      Game intervention should be adopted by other schools struggling with low student engagement;
      and depending on the results, it could lead to a larger, more rigorous study that would
      evaluate whether the Gradebook Game is effective in promoting school engagement and
      achievement among a diverse study population, which could be beneficial to schools and
      families across the nation.
observational model: Case-Control
time perspective: Prospective
measure: Academic and Behavior Information
time frame: up to 20 times during 6 month period
description: collect school grade book and behavior information weekly for 8 to 10 time points before and after the intervention is implemented.
measure: Social Emotional well being, social status and peer support
time frame: baseline and at 6 months
description: Survey data will be collected via iPad using a study ID during non-content periods at school (Advisory and Enrichment). Surveys will include measures of self-reported school engagement, social-emotional well-being, and peer support.
arm group label: Intervention
description: The middle school selected 2 advisory classrooms to participate in the Gradebook game during 6th grade. Students in these 2 classrooms were block randomized to teams by baseline grade book and student engagement scores. These small student teams stay together for an entire year and meet once or twice a week. Teams are led by 8th grade student team captains, picked by school staff for their positive leadership skills. Every 2 weeks throughout the year, teams are randomly matched in head-to-head competition. In each 2-week-long game (i.e. Gradebook Game), individual team members accrue points from teachers and administrators for academic performance, effort, and school behavior. Team wins are announced and public scoreboards are updated frequently. The investigators will collect student survey data at baseline and after the intervention, approximately 5-6 months apart.
arm group label: Control
description: The middle school has chosen three 6th grade classrooms that will not play the Gradebook game. The investigators will collect school gradebook and behavior information weekly for 8 to 10 time points before and after the intervention is implemented. Students will complete a survey at baseline and after the intervention, approximately 5-6 months apart.
intervention type: Other
intervention name: Gradebook Game
description: Students in the intervention group will spend time meeting as teams to review their scorecards, and do team-building activities, all of which will occur during non-content periods at school (Advisory and Enrichment).
arm group label: Intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
last name: Mitchell D Wong, MD, PhD
role: Study Chair
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Mitchell Wong, MD, PhD
investigator title: Professor of Medicine; Faculty Mentor
sharing ipd: No
ipd description: Participants have been assigned a study ID number to link their name, address, phone number, grade book and behavior data, and survey responses. This ID will be used for all survey data collection and to identify all grade book and behavior data.
The computer file linking the personal identifiers and the study ID number will be kept separate from the survey, grade book, and behavior data. Personally identifying information pertaining to individual participants will not be shared or made available to other researchers. Any data request will be made to the Faculty Sponsor (Mitchell Wong, MD PhD) or to the principle investigator (Ashley Lewis-Hunter, MD) and any data shared will be encrypted and will not include any personal identifying information.