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/NCT06002347</url>
    </required_header>
    <id_info>
      <org_study_id>101-SB21-051</org_study_id>
      <secondary_id>5U54GM104944</secondary_id>
      <nct_id>NCT06002347</nct_id>
    </id_info>
    <brief_title>Middle School Parent Module for a Brief Bullying Intervention Program</brief_title>
    <official_title>Development, Acceptability, and Short-Term Outcomes of a Parent 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>National Institute of General Medical Sciences (NIGMS)</agency>
        <agency_class>NIH</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 parent training designed as&#xD;
        a companion module to a bullying bystander intervention (STAC) for middle school students in&#xD;
        rural communities. The aim of this project is to provide a brief, low-cost intervention that&#xD;
        can be easily disseminated as part of a school-based bullying prevention program to address&#xD;
        this important public health problem.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 5, 2022</start_date>
    <completion_date type="Actual">April 16, 2022</completion_date>
    <primary_completion_date type="Actual">April 16, 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>Modified version of Teacher-Advocates Pre- and Post-Scale (TAPPS) Knowledge and confidence to support defenders was measured using a modified version of 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>Modified version of Teacher's Attitudes about Bullying Questionnaire Confidence about managing bullying was measured using a modified version of 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 Parent comfort with managing bullying was measured using items from the National Education Association Bullying Survey. Parents 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 and definitions (a) Physical (hitting, pushing, or kicking), (b) Verbal (general teasing or name calling), (c) Relational (rumor spreading or excluding someone from a group), (d) Cyberbullying (sending or posting harmful material or engaging in other forms of social aggression using the Internet or other digital devices, such as mobile phones), and (e) Sexting (sending or forwarding sexually explicit photos, videos or messages from a mobile phone or other electronic device). 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.&#xD;
  The Provictim scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parental Role</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>National Education Association Bullying Survey Parental role in handling bullying situations was measured by four items from the National Education Association Bullying Survey. Items are rated on a 4-point Likert Scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and are summed to create the scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bullying Self-Efficacy</measure>
      <time_frame>pre-training; immediate post training</time_frame>
      <description>Bullying Self-Efficacy Parents' perceptions of ability to help the participants' child respond to bullying were measured using a 6-item scale. Items are rated on a 4-point Likert Scale ranging from 1 (Not at All) to 4 (A Lot) and are summed to create the scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Communication Self-Efficacy</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>Communication Self-Efficacy Parents' self-efficacy to talk with the participants' child about bullying was assessed using a 5-item scale. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to create the scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attitudes about Bullying</measure>
      <time_frame>pre-training; immediate post-training</time_frame>
      <description>Provictim Scale Attitudes about bullying were measured using the Provictim Scale, including 6 items that reflect anti-bullying attitudes. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to create the scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intention to Use Parent STAC Strategies</measure>
      <time_frame>immediate post-training</time_frame>
      <description>Use of STAC Strategies The intention to use Parent STAC strategies was measured using an adapted version of the Use of STAC Strategies for students and teachers. The 4-item measure asks parents &quot;How likely is the participant to use these strategies to support the participants' adolescent to intervene in bullying in the future? a) Stealing the Show - support adolescents to use humor or distraction to get the attention away from the bullying situation, b) Turning it Over - support adolescents who tell the partcipant about bullying or support adolescents to report to an adult at school, c) Accompanying Others - support adolescents who reach out to a student who was a target of bullying, and d) Coaching Compassion - support adolescents 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 of the Parent STAC Training</measure>
      <time_frame>immediate post-training</time_frame>
      <description>Acceptability of the Parent STAC Training Program acceptability was assessed using a social validity survey composed of 7 items. Items were ranked on a 4-point scale from 1 (Strongly Disagree) to 4 (Strongly Agree).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interest in Receiving Bullying Prevention</measure>
      <time_frame>immediate post-training</time_frame>
      <description>Interest in Receiving Bullying Prevention Participants were asked how interested the participant would be in receiving bullying prevention programming on a 5-point response scale with anchors ranging from 1 (Not at all Interested) to 5 (Extremely Interested).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Features of a Technology-Based Program</measure>
      <time_frame>immediate post-training</time_frame>
      <description>Features of A Technology-Based Program Participants were asked a series of questions regarding features of a technology-based program. Items were rated on a 5-point scale from 1 (Not at All Important) to 4 (Extremely Important).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">23</enrollment>
    <condition>Bullying</condition>
    <arm_group>
      <arm_group_label>STAC Parent Module</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STAC Parent Module for Middle School</intervention_name>
      <description>The STAC Parent Module is a 30-minute pre-recorded online presentation that includes normative feedback, didactic information, a review of the student STAC strategies and corresponding strategies parents can use to support students who act as defenders, and information about &quot;perceptions vs. facts&quot; about bullying.</description>
      <arm_group_label>STAC Parent Module</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Being a parent of an adolescent enrolled in grades 6, 7, or 8 in a participating&#xD;
               middle school in Idaho.&#xD;
  &#xD;
            2. Speaks and reads English.&#xD;
  &#xD;
            3. Consents to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Speaks and reads only a language other than English.&#xD;
  &#xD;
            2. 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 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>
    <pending_results>
      <submitted>August 21, 2023</submitted>
      <returned>September 15, 2023</returned>
    </pending_results>
    <!-- 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/NCT06002347
  org study id: 101-SB21-051
  secondary id: 5U54GM104944
  nct id: NCT06002347
  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 parent 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: Modified version of Teacher-Advocates Pre- and Post-Scale (TAPPS) Knowledge and confidence to support defenders was measured using a modified version of 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: Modified version of Teacher's Attitudes about Bullying Questionnaire Confidence about managing bullying was measured using a modified version of 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 Parent comfort with managing bullying was measured using items from the National Education Association Bullying Survey. Parents were asked "How comfortable would the participant feel intervening when the participant sees the following bullying behaviors?" followed by five types of bullying and definitions (a) Physical (hitting, pushing, or kicking), (b) Verbal (general teasing or name calling), (c) Relational (rumor spreading or excluding someone from a group), (d) Cyberbullying (sending or posting harmful material or engaging in other forms of social aggression using the Internet or other digital devices, such as mobile phones), and (e) Sexting (sending or forwarding sexually explicit photos, videos or messages from a mobile phone or other electronic device). 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.
  The Provictim scale
  measure: Parental Role
  time frame: pre-training; immediate post-training
  description: National Education Association Bullying Survey Parental role in handling bullying situations was measured by four items from the National Education Association Bullying Survey. Items are rated on a 4-point Likert Scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and are summed to create the scale.
  measure: Bullying Self-Efficacy
  time frame: pre-training; immediate post training
  description: Bullying Self-Efficacy Parents' perceptions of ability to help the participants' child respond to bullying were measured using a 6-item scale. Items are rated on a 4-point Likert Scale ranging from 1 (Not at All) to 4 (A Lot) and are summed to create the scale.
  measure: Communication Self-Efficacy
  time frame: pre-training; immediate post-training
  description: Communication Self-Efficacy Parents' self-efficacy to talk with the participants' child about bullying was assessed using a 5-item scale. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to create the scale.
  measure: Attitudes about Bullying
  time frame: pre-training; immediate post-training
  description: Provictim Scale Attitudes about bullying were measured using the Provictim Scale, including 6 items that reflect anti-bullying attitudes. Items are rated on a 5-point Likert Scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and are summed to create the scale.
  measure: Intention to Use Parent STAC Strategies
  time frame: immediate post-training
  description: Use of STAC Strategies The intention to use Parent STAC strategies was measured using an adapted version of the Use of STAC Strategies for students and teachers. The 4-item measure asks parents "How likely is the participant to use these strategies to support the participants' adolescent to intervene in bullying in the future? a) Stealing the Show - support adolescents to use humor or distraction to get the attention away from the bullying situation, b) Turning it Over - support adolescents who tell the partcipant about bullying or support adolescents to report to an adult at school, c) Accompanying Others - support adolescents who reach out to a student who was a target of bullying, and d) Coaching Compassion - support adolescents 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 of the Parent STAC Training
  time frame: immediate post-training
  description: Acceptability of the Parent STAC Training Program acceptability was assessed using a social validity survey composed of 7 items. Items were ranked on a 4-point scale from 1 (Strongly Disagree) to 4 (Strongly Agree).
  measure: Interest in Receiving Bullying Prevention
  time frame: immediate post-training
  description: Interest in Receiving Bullying Prevention Participants were asked how interested the participant would be in receiving bullying prevention programming on a 5-point response scale with anchors ranging from 1 (Not at all Interested) to 5 (Extremely Interested).
  measure: Features of a Technology-Based Program
  time frame: immediate post-training
  description: Features of A Technology-Based Program Participants were asked a series of questions regarding features of a technology-based program. Items were rated on a 5-point scale from 1 (Not at All Important) to 4 (Extremely Important).
  arm group label: STAC Parent Module
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: STAC Parent Module for Middle School
  description: The STAC Parent Module is a 30-minute pre-recorded online presentation that includes normative feedback, didactic information, a review of the student STAC strategies and corresponding strategies parents can use to support students who act as defenders, and information about "perceptions vs. facts" about bullying.
  arm group label: STAC Parent 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
  submitted: August 21, 2023
  returned: September 15, 2023