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/NCT06017752</url>
    </required_header>
    <id_info>
      <org_study_id>101-SB20-174</org_study_id>
      <nct_id>NCT06017752</nct_id>
    </id_info>
    <brief_title>Middle School Teacher Module for a Brief Bullying Intervention Program</brief_title>
    <official_title>Development, Acceptability, and Short-Term Outcomes of a Teacher Module for a Brief, Bullying Bystander Intervention for Middle School Students in Rural, Low-Income Communities</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boise State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mental Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boise State University</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>
        This study evaluates the feasibility and short-term outcomes of a teacher training designed&#xD;
        as a companion module to a bullying bystander intervention (STAC) for middle school students&#xD;
        in rural communities. The aim of this project is to provide a brief, low-cost intervention&#xD;
        that can be easily disseminated as part of a school-based bullying prevention program to&#xD;
        address this important public health problem.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 21, 2022</start_date>
    <completion_date type="Actual">January 24, 2022</completion_date>
    <primary_completion_date type="Actual">January 24, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knowledge and Confidence to Support Defenders</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>Teacher-Advocates Pre- and Post-Scale (TAPPS) Knowledge and confidence to support defenders was measured using the TAPPS. The TAPPS is an 11 item survey that measures knowledge of buying behaviors, knowledge of how to support students using the STAC strategies, and confidence supporting students who intervene in bullying situations. Items are rated on a 4-point Likert Scale ranging from 1 (Totally Disagree) to 4 (Totally Agree) and were summed to compute a total scale score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Confidence Managing Bullying</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>Teacher's Attitudes about Bullying Questionnaire Confidence about managing bullying was measured using the Teacher's Attitudes about Bullying Questionnaire. This questionnaire is a 22 item survey. The 3-item Confidence in Managing Bullying Subscale was used. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to compute a total scale score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comfort Managing Bullying</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>National Education Association Bullying Survey Comfort with managing bullying was measured using items from the National Education Association Bullying Survey. Participants were asked &quot;How comfortable would the participant feel intervening when the participant sees the following bullying behaviors?&quot; followed by five types of bullying (a) Physical, (b) Verbal, (c) Relational, (d) Cyberbullying , and (e) Sexting. Items are rated on a 5-point Likert Scale ranging from 1 (Very Uncomfortable) to 5 (Very Comfortable) and are summed to compute a total scale score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bullying Self-Efficacy</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>Bullying Self-Efficacy Teachers' self-efficacy in handling bullying situations was measured by two items from the National Education Association Bullying Survey. The items are rated on a 4-point Likert Scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and are summed to compute a total scale score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intention to Use Parent STAC Strategies</measure>
      <time_frame>immediate post-training</time_frame>
      <description>The intention to use Teacher STAC strategies was measured using an adapted version of the Use of STAC Strategies for students. Items were adapted from the student version to be appropriate for teachers. The 4-item measures asks teachers &quot;How likely the participant is to support students using these strategies to intervene in bullying in the future?: a) Stealing the Show - support students using humor or distraction to get the attention away from the bullying situation, b) Turning it Over - support a student who reported bullying to the participant or supporting students to report to a principal or School Resource Officer (SRO), c) Accompanying Others - support students who reach out to the student who was the target of bullying, or d) Coaching Compassion - support students who help the student who bullied develop empathy for the target.&quot; Items are rated on a 5-point Likert Scale ranging from 1 (Very Unlikely) to 5 (Very Likely).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability and Relevance of the Teacher STAC Training</measure>
      <time_frame>immediate post-training</time_frame>
      <description>Acceptability and relevance of the STAC training was assessed using a social validity survey comprised of 8 items. Items were ranked on a 4-point scale from 1 (Strongly Disagree) to 4 (Strongly Agree).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Bullying</condition>
    <arm_group>
      <arm_group_label>STAC Teacher Module</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STAC Teacher Module</intervention_name>
      <description>The STAC Teacher Module is a 30-minute presentation that includes normative feedback, didactic information, a review of the student STAC strategies and corresponding strategies teachers can use to support students who act as defenders, and information about &quot;perceptions vs. facts&quot; about bullying.</description>
      <arm_group_label>STAC Teacher Module</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a teacher of an adolescent enrolled in grades 6, 7, or 8 in a participating&#xD;
               middle school in Idaho.&#xD;
  &#xD;
            -  Speaks and reads English.&#xD;
  &#xD;
            -  Consents to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Speaks and reads only a language other than English.&#xD;
  &#xD;
            -  Does not consent for participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Boise State Univerity</name>
        <address>
          <city>Boise</city>
          <state>Idaho</state>
          <zip>83725</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Boise State University</investigator_affiliation>
      <investigator_full_name>Aida Midgett</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bullying</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06017752
  org study id: 101-SB20-174
  nct id: NCT06017752
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates the feasibility and short-term outcomes of a teacher training designed
        as a companion module to a bullying bystander intervention (STAC) for middle school students
        in rural communities. The aim of this project is to provide a brief, low-cost intervention
        that can be easily disseminated as part of a school-based bullying prevention program to
        address this important public health problem.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Knowledge and Confidence to Support Defenders
  time frame: pre-training; immediate post-training
  description: Teacher-Advocates Pre- and Post-Scale (TAPPS) Knowledge and confidence to support defenders was measured using the TAPPS. The TAPPS is an 11 item survey that measures knowledge of buying behaviors, knowledge of how to support students using the STAC strategies, and confidence supporting students who intervene in bullying situations. Items are rated on a 4-point Likert Scale ranging from 1 (Totally Disagree) to 4 (Totally Agree) and were summed to compute a total scale score.
  measure: Confidence Managing Bullying
  time frame: pre-training; immediate post-training
  description: Teacher's Attitudes about Bullying Questionnaire Confidence about managing bullying was measured using the Teacher's Attitudes about Bullying Questionnaire. This questionnaire is a 22 item survey. The 3-item Confidence in Managing Bullying Subscale was used. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to compute a total scale score.
  measure: Comfort Managing Bullying
  time frame: pre-training; immediate post-training
  description: National Education Association Bullying Survey Comfort with managing bullying was measured using items from the National Education Association Bullying Survey. Participants were asked "How comfortable would the participant feel intervening when the participant sees the following bullying behaviors?" followed by five types of bullying (a) Physical, (b) Verbal, (c) Relational, (d) Cyberbullying , and (e) Sexting. Items are rated on a 5-point Likert Scale ranging from 1 (Very Uncomfortable) to 5 (Very Comfortable) and are summed to compute a total scale score.
  measure: Bullying Self-Efficacy
  time frame: pre-training; immediate post-training
  description: Bullying Self-Efficacy Teachers' self-efficacy in handling bullying situations was measured by two items from the National Education Association Bullying Survey. The items are rated on a 4-point Likert Scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and are summed to compute a total scale score.
  measure: Intention to Use Parent STAC Strategies
  time frame: immediate post-training
  description: The intention to use Teacher STAC strategies was measured using an adapted version of the Use of STAC Strategies for students. Items were adapted from the student version to be appropriate for teachers. The 4-item measures asks teachers "How likely the participant is to support students using these strategies to intervene in bullying in the future?: a) Stealing the Show - support students using humor or distraction to get the attention away from the bullying situation, b) Turning it Over - support a student who reported bullying to the participant or supporting students to report to a principal or School Resource Officer (SRO), c) Accompanying Others - support students who reach out to the student who was the target of bullying, or d) Coaching Compassion - support students who help the student who bullied develop empathy for the target." Items are rated on a 5-point Likert Scale ranging from 1 (Very Unlikely) to 5 (Very Likely).
  measure: Acceptability and Relevance of the Teacher STAC Training
  time frame: immediate post-training
  description: Acceptability and relevance of the STAC training was assessed using a social validity survey comprised of 8 items. Items were ranked on a 4-point scale from 1 (Strongly Disagree) to 4 (Strongly Agree).
  arm group label: STAC Teacher Module
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: STAC Teacher Module
  description: The STAC Teacher Module is a 30-minute presentation that includes normative feedback, didactic information, a review of the student STAC strategies and corresponding strategies teachers can use to support students who act as defenders, and information about "perceptions vs. facts" about bullying.
  arm group label: STAC Teacher Module
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Boise State University
  investigator full name: Aida Midgett
  investigator title: Professor
  mesh term: Bullying
  sharing ipd: No