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/NCT06017050</url>
    </required_header>
    <id_info>
      <org_study_id>R21HD104369</org_study_id>
      <nct_id>NCT06017050</nct_id>
    </id_info>
    <brief_title>BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth</brief_title>
    <official_title>Developing a Bullying Prevention Program That Transcends Physical Boundaries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Center for Innovative Public Health Research</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Center for Innovative Public Health Research</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>
        Given the limited impact of existing school-based interventions and the time associated with&#xD;
        implementing them during school time, more efficient and effective intervention methods are&#xD;
        needed. Programs that can be delivered to middle school youth irrespective of whether they&#xD;
        are attending school physically or virtually may be especially relevant as school boundaries&#xD;
        become more fluid. BullyDown addresses this critical need by providing a scalable program&#xD;
        that could be quickly and cost-effectively disseminated nationally.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <intervention_model_description>Youth will be randomized to either the intervention or control group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of the intervention</measure>
      <time_frame>Through study completion, anticipated to be 1 year</time_frame>
      <description>Recruitment and enrollment rates</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>Intervention end, 8 weeks after program enrollment</time_frame>
      <description>Positive program appraisal</description>
    </primary_outcome>
    <other_outcome>
      <measure>Relatively lower rates of bullying perpetration in the intervention versus control group</measure>
      <time_frame>In the past 30 days at 3-months post-randomzied controlled trial (RCT) end</time_frame>
      <description>Bullying other youth the same age</description>
    </other_outcome>
    <other_outcome>
      <measure>Relatively lower rates of aggressive behavior in the intervention versus control group</measure>
      <time_frame>In the past 30 days at 3-months post-RCT end</time_frame>
      <description>Youth who report aggressive acts that do not meet the definition of bullying</description>
    </other_outcome>
    <other_outcome>
      <measure>Relatively higher rates of bystanding behavior in the intervention versus control group</measure>
      <time_frame>In the past 30 days at 3-months post-RCT end</time_frame>
      <description>Intervening when a youth sees others being bullied as measured by the University of Illinois Willingness to Intervene scale</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Bullying</condition>
    <arm_group>
      <arm_group_label>BullyDown intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy lifestyle control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>BullyDown</intervention_name>
      <description>BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.</description>
      <arm_group_label>BullyDown intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Attention-matched control</intervention_name>
      <description>The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.</description>
      <arm_group_label>Healthy lifestyle control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  7th or 8th grade&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Own their own cell phone&#xD;
  &#xD;
            -  Home internet&#xD;
  &#xD;
            -  Provide informed assent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speakers&#xD;
  &#xD;
            -  Unable to read the screener&#xD;
  &#xD;
            -  Know someone else in the RCT&#xD;
  &#xD;
            -  Know they are not on an unlimited text messaging plan&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Center for Innovative Public Health Research</name>
        <address>
          <city>San Clemente</city>
          <state>California</state>
          <zip>92672-6745</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michele L Ybarra, MPH PhD</last_name>
        <phone>877-302-6858</phone>
        <phone_ext>801</phone_ext>
        <email>Michele@InnovativePublicHealth.org</email>
      </contact>
      <investigator>
        <last_name>Michele L Ybarra, MPH PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599-2100</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bullying</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 5, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT06017050/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06017050
  org study id: R21HD104369
  nct id: NCT06017050
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Given the limited impact of existing school-based interventions and the time associated with
        implementing them during school time, more efficient and effective intervention methods are
        needed. Programs that can be delivered to middle school youth irrespective of whether they
        are attending school physically or virtually may be especially relevant as school boundaries
        become more fluid. BullyDown addresses this critical need by providing a scalable program
        that could be quickly and cost-effectively disseminated nationally.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Youth will be randomized to either the intervention or control group.
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).
  measure: Feasibility of the intervention
  time frame: Through study completion, anticipated to be 1 year
  description: Recruitment and enrollment rates
  measure: Acceptability of the intervention
  time frame: Intervention end, 8 weeks after program enrollment
  description: Positive program appraisal
  measure: Relatively lower rates of bullying perpetration in the intervention versus control group
  time frame: In the past 30 days at 3-months post-randomzied controlled trial (RCT) end
  description: Bullying other youth the same age
  measure: Relatively lower rates of aggressive behavior in the intervention versus control group
  time frame: In the past 30 days at 3-months post-RCT end
  description: Youth who report aggressive acts that do not meet the definition of bullying
  measure: Relatively higher rates of bystanding behavior in the intervention versus control group
  time frame: In the past 30 days at 3-months post-RCT end
  description: Intervening when a youth sees others being bullied as measured by the University of Illinois Willingness to Intervene scale
  arm group label: BullyDown intervention
  arm group type: Experimental
  arm group label: Healthy lifestyle control
  arm group type: Placebo Comparator
  intervention type: Behavioral
  intervention name: BullyDown
  description: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.
  arm group label: BullyDown intervention
  intervention type: Behavioral
  intervention name: Attention-matched control
  description: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.
  arm group label: Healthy lifestyle control
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Completed
  country: United States
  responsible party type: Sponsor
  mesh term: Bullying
  provided document: 