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/NCT06002191</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY22070044</org_study_id>
      <secondary_id>K23MH131759</secondary_id>
      <nct_id>NCT06002191</nct_id>
    </id_info>
    <brief_title>Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents</brief_title>
    <official_title>Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pittsburgh</source>
    <oversight_info>
      <has_dmc>Yes</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 objective of this study is to test the feasibility and preliminary efficacy of Flourish&#xD;
        (formerly referred to as imHere4U), a digital suicide prevention intervention for&#xD;
        cyberbullied adolescents.&#xD;
  &#xD;
        The specific aims are to:&#xD;
  &#xD;
        Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs.&#xD;
        Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, &gt;35%&#xD;
        underserved youth).&#xD;
  &#xD;
        H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates &gt; 80% and&#xD;
        imHere4U engagement &gt; 70%.&#xD;
  &#xD;
        H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved&#xD;
        problem-solving capacity, distress tolerance, and motivation and reduced distress and&#xD;
        suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up&#xD;
        period.&#xD;
  &#xD;
        Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from&#xD;
        machine learning algorithms. All youth assigned to Flourish may optionally provide their&#xD;
        social media data to receive feedback from machine learning algorithms. H3a. Feedback from&#xD;
        algorithms will have high acceptability (identified via qualitative themes and &gt;70%&#xD;
        acceptance rates) and usability, defined by mean scores on Post-Study System and Usability&#xD;
        Questionnaire (PSSUQ) &gt; 6.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Assessment Visits:&#xD;
  &#xD;
        As part of this study, adolescents will participate in four assessment visits at baseline and&#xD;
        4, 12, and 24 weeks following onboarding to the study intervention. Assessments cover a range&#xD;
        of topics including mood, anxiety, suicidal thoughts and behaviors, and social media use and&#xD;
        experience. At the time of the baseline visit, youth will be selected to receive either&#xD;
        Flourish+Questionnaires (intervention condition) or Questionnaires Alone (control condition).&#xD;
        Selection will occur through randomization, referring essentially to asking a computer to&#xD;
        &quot;flip a coin&quot; to decide which group the participant will be assigned to.&#xD;
  &#xD;
        Control Condition: Questionnaires Alone Youth in the control condition will be onboarded to a&#xD;
        chatbot by a study clinician. A chatbot refers to an automated intervention that leverages&#xD;
        chat-based conversations to communicate intervention content. This chatbot is designed solely&#xD;
        to send structured brief questionnaires about online interactions via text messaging.&#xD;
        Questionnaires assess the presence of negative/bullying interactions and positive/supportive&#xD;
        interactions, once every 3 days. Mirroring the intervention condition, youth will receive&#xD;
        this simplified chatbot for 4 weeks. If youth endorse negative/bullying interactions, they&#xD;
        will be provided with information for crisis contacts (e.g., crisis hotline information).&#xD;
  &#xD;
        Intervention Condition: Flourish Flourish is a chatbot that will aim to improve adolescents'&#xD;
        capacity to cope following cyberbullying and reduce their suicidal risk. The duration of&#xD;
        Flourish is 4 weeks. Flourish is designed to be self-paced with branching logic, aiming to&#xD;
        provide the right type of support at the right time youth need it. Therefore, the frequency&#xD;
        with which youth interact with Flourish will differ from person to person. However,&#xD;
        participants are expected to interact with Flourish approximately 2-3 times per week.&#xD;
  &#xD;
        Onboarding to Flourish. Prior to initiating Flourish, adolescents and their caregivers will&#xD;
        participate in a session of approximately 30 minutes with a study clinician in which they&#xD;
        will onboard to Flourish. During onboarding, the clinician will orient the adolescent to&#xD;
        Flourish and load information onto Flourish that will be available to the adolescent&#xD;
        throughout their use of the intervention. This will include personal crisis contacts, such as&#xD;
        trusted adults and crisis hotlines they could contact in the event of a crisis, as well as&#xD;
        contacts for people they could reach out to for support or distraction outside of a crisis&#xD;
        situation, such as a close friend or a family member. Adolescents will additionally enter&#xD;
        information to personalize their experience with Flourish, such as entering preferences for&#xD;
        coping skills that work best for them. During the onboarding process, caregivers will be&#xD;
        provided with resources to respond to cyberbullying as well as information on their child's&#xD;
        personal crisis resources.&#xD;
  &#xD;
        Questionnaires through Flourish. Youth in the intervention group will receive questionnaires&#xD;
        evaluating online experiences mirroring those received by the control group. If adolescents&#xD;
        indicate negative interactions, Flourish will automatically launch providing supportive&#xD;
        resources including crisis resources. If adolescents indicate supportive interactions (or no&#xD;
        interactions), they will be given the option to launch Flourish to practice their coping&#xD;
        skills, so they are prepared to respond to future cyberbullying events.&#xD;
  &#xD;
        Resource Website for Flourish. Participants receiving Flourish will also have access to an&#xD;
        accompanying website. The website will not collect or store any private information from the&#xD;
        participant, and the participant will not interact with the website. It is a publicly&#xD;
        available website that provides a list of resources participants may use, if needed. For&#xD;
        example, this will include youth mental health organizations and organizations that provide&#xD;
        education, support, and advocacy for youth who have experienced cyberbullying.&#xD;
  &#xD;
        Social Media Data Collection and Feedback. Youth in both groups (Flourish+questionnaires and&#xD;
        Questionnaires Alone) will have the option to provide their social media archives as part of&#xD;
        the study. Software will strip identifiable information (e.g., names, dates of birth,&#xD;
        locations, etc.) to the extent possible from the archives. Archives will be analyzed using&#xD;
        software that detects presence of positive and negative social interactions. Those assigned&#xD;
        to Flourish+Questionnaires will receive feedback from their online interactions, which is&#xD;
        anticipated to help youth gain recognition and awareness of their online environment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</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>The study design is a randomized controlled trial.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rates of eligible participants</measure>
      <time_frame>Assessed upon recruitment to the study</time_frame>
      <description>Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rates of eligible participants</measure>
      <time_frame>Assessed upon completion of the Week 12 study visits</time_frame>
      <description>Feasibility will be measured through retention rates of eligible participants, using a cut-off score of 80% for desirable retention rates across the 12-week study period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of intervention usage</measure>
      <time_frame>Assessed upon completion of the 4-week intervention period</time_frame>
      <description>Usage of the intervention will be assessed by engagement with the text messaging intervention one or more times during the study period. A cut-off score of 70% of youth using the intervention one or more times will be used as a minimum requirement for acceptable usage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in psychological distress from baseline to 4 weeks</measure>
      <time_frame>Assessed at the baseline and Week 4 follow-up assessment visits</time_frame>
      <description>Psychological distress will be measured by the Kessler 6-item psychological distress scale (K6). Total scale scores range from 0 to 24 with higher values indicating higher levels of distress and lower values indicating lower distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in psychological distress from baseline to 12 weeks</measure>
      <time_frame>Assessed at the Week 12 follow-up assessment visits</time_frame>
      <description>Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in severity of suicidal ideation and behavior from baseline to 4 weeks</measure>
      <time_frame>Assessed at baseline and Week 4 follow-up assessment visits</time_frame>
      <description>Severity of suicidal ideation and behavior will be measured with the Columbia Suicide Severity Rating Scale (C-SSRS), an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in severity of suicidal ideation and behavior from baseline to 12 weeks</measure>
      <time_frame>Assessed at baseline and Week 12 follow-up assessment visits</time_frame>
      <description>Severity of suicidal ideation and behavior will be measured with the C-SSRS, an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in suicidal ideation from baseline to 4 weeks</measure>
      <time_frame>Assessed at the baseline and Week 4 assessment visits</time_frame>
      <description>Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire (SIQ). The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in suicidal ideation from baseline to 12 weeks</measure>
      <time_frame>Assessed at the baseline and Week 12 Follow-up assessment visits</time_frame>
      <description>Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire. The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in distress tolerance from baseline to 4 weeks</measure>
      <time_frame>Assessed at the baseline and Week 4 assessment visits</time_frame>
      <description>Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in distress tolerance from baseline to 12 weeks</measure>
      <time_frame>Assessed at the baseline and Week 12 assessment visit</time_frame>
      <description>Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in motivation for help-seeking from baseline to 4 weeks</measure>
      <time_frame>Assessed at the baseline and Week 4 assessment visits</time_frame>
      <description>Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in motivation for help-seeking from baseline to 12 weeks</measure>
      <time_frame>Assessed at the baseline and Week 12 follow-up assessment visits</time_frame>
      <description>Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in social problem-solving from baseline to 4 weeks</measure>
      <time_frame>Assessed at baseline and Week 4 assessment visits</time_frame>
      <description>Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in social problem-solving from baseline to 12 weeks</measure>
      <time_frame>Assessed at the baseline and Week 12 assessment visits</time_frame>
      <description>Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Psychological Distress</condition>
    <condition>Suicidal Ideation</condition>
    <arm_group>
      <arm_group_label>Flourish + Questionnaires</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be onboarded to Flourish by a research study clinician, following which they will receive a text messaging program for 4 weeks as well as an accompanying resources website. As part of the text messaging program, participants will receive brief questionnaires evaluating their online experiences once every 3 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Questionnaires Alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be onboarded to a text message program that solely will send participants brief questionnaires evaluating their online experiences once every 3 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Flourish</intervention_name>
      <description>Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.</description>
      <arm_group_label>Flourish + Questionnaires</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Questionnaires of Online Experiences</intervention_name>
      <description>Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.</description>
      <arm_group_label>Flourish + Questionnaires</arm_group_label>
      <arm_group_label>Questionnaires Alone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
            -  access to a phone or device capable of text messaging&#xD;
  &#xD;
            -  past 3-month history of cyberbullying assessed by the cybervictimization subscale of&#xD;
               the Traditional Bullying and Cyberbullying Victimization and Perpetration Scale and/or&#xD;
               presence of online discrimination measured by a modified version of a discrimination&#xD;
               measured developed as part of the Adolescent Brain and Cognitive Development (ABCD)&#xD;
               study&#xD;
  &#xD;
            -  past 3-month history of suicidal risk, including: psychological distress (&gt;13 on the&#xD;
               6-item Kessler Psychological Distress Scale) and/or suicidal ideation or behavior (via&#xD;
               the Columbia Suicide Severity Rating Scale)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  intellectual challenges, low literacy levels, or other conditions that might inhibit&#xD;
               adolescents' ability to effectively engage with Flourish (reported by parents and, if&#xD;
               needed, confirmed through the age-appropriate Wechsler Intelligence scale)&#xD;
  &#xD;
            -  acuity levels suggesting need for a higher level of care (e.g., inpatient&#xD;
               hospitalization) or referral for emergency services&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Candice L Biernesser, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Candice L Biernesser, PhD</last_name>
      <phone>412-586-9064</phone>
      <email>lubbertcl@upmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Pittsburgh Medical Center</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</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 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 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 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Candice Biernesser</investigator_full_name>
      <investigator_title>Assistant Professor of Psychiatry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Suicidal Ideation</mesh_term>
      <mesh_term>Suicide Prevention</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data from enrolled participants may be shared with investigators within and outside of the University of Pittsburgh and University of Pittsburgh Medical Center for the purpose of studying cyberbullying or suicide risk among adolescents. Data sharing will be consistent with International Committee of Medical Journal Editors (ICMJE) requirements.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>These data will be released following acceptance of the project's main outcomes manuscript.</ipd_time_frame>
      <ipd_access_criteria>Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.</ipd_access_criteria>
    </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/NCT06002191
  org study id: STUDY22070044
  secondary id: K23MH131759
  nct id: NCT06002191
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to test the feasibility and preliminary efficacy of Flourish
        (formerly referred to as imHere4U), a digital suicide prevention intervention for
        cyberbullied adolescents.
  
        The specific aims are to:
  
        Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs.
        Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, >35%
        underserved youth).
  
        H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates > 80% and
        imHere4U engagement > 70%.
  
        H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved
        problem-solving capacity, distress tolerance, and motivation and reduced distress and
        suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up
        period.
  
        Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from
        machine learning algorithms. All youth assigned to Flourish may optionally provide their
        social media data to receive feedback from machine learning algorithms. H3a. Feedback from
        algorithms will have high acceptability (identified via qualitative themes and >70%
        acceptance rates) and usability, defined by mean scores on Post-Study System and Usability
        Questionnaire (PSSUQ) > 6.
  Assessment Visits:
  
        As part of this study, adolescents will participate in four assessment visits at baseline and
        4, 12, and 24 weeks following onboarding to the study intervention. Assessments cover a range
        of topics including mood, anxiety, suicidal thoughts and behaviors, and social media use and
        experience. At the time of the baseline visit, youth will be selected to receive either
        Flourish+Questionnaires (intervention condition) or Questionnaires Alone (control condition).
        Selection will occur through randomization, referring essentially to asking a computer to
        "flip a coin" to decide which group the participant will be assigned to.
  
        Control Condition: Questionnaires Alone Youth in the control condition will be onboarded to a
        chatbot by a study clinician. A chatbot refers to an automated intervention that leverages
        chat-based conversations to communicate intervention content. This chatbot is designed solely
        to send structured brief questionnaires about online interactions via text messaging.
        Questionnaires assess the presence of negative/bullying interactions and positive/supportive
        interactions, once every 3 days. Mirroring the intervention condition, youth will receive
        this simplified chatbot for 4 weeks. If youth endorse negative/bullying interactions, they
        will be provided with information for crisis contacts (e.g., crisis hotline information).
  
        Intervention Condition: Flourish Flourish is a chatbot that will aim to improve adolescents'
        capacity to cope following cyberbullying and reduce their suicidal risk. The duration of
        Flourish is 4 weeks. Flourish is designed to be self-paced with branching logic, aiming to
        provide the right type of support at the right time youth need it. Therefore, the frequency
        with which youth interact with Flourish will differ from person to person. However,
        participants are expected to interact with Flourish approximately 2-3 times per week.
  
        Onboarding to Flourish. Prior to initiating Flourish, adolescents and their caregivers will
        participate in a session of approximately 30 minutes with a study clinician in which they
        will onboard to Flourish. During onboarding, the clinician will orient the adolescent to
        Flourish and load information onto Flourish that will be available to the adolescent
        throughout their use of the intervention. This will include personal crisis contacts, such as
        trusted adults and crisis hotlines they could contact in the event of a crisis, as well as
        contacts for people they could reach out to for support or distraction outside of a crisis
        situation, such as a close friend or a family member. Adolescents will additionally enter
        information to personalize their experience with Flourish, such as entering preferences for
        coping skills that work best for them. During the onboarding process, caregivers will be
        provided with resources to respond to cyberbullying as well as information on their child's
        personal crisis resources.
  
        Questionnaires through Flourish. Youth in the intervention group will receive questionnaires
        evaluating online experiences mirroring those received by the control group. If adolescents
        indicate negative interactions, Flourish will automatically launch providing supportive
        resources including crisis resources. If adolescents indicate supportive interactions (or no
        interactions), they will be given the option to launch Flourish to practice their coping
        skills, so they are prepared to respond to future cyberbullying events.
  
        Resource Website for Flourish. Participants receiving Flourish will also have access to an
        accompanying website. The website will not collect or store any private information from the
        participant, and the participant will not interact with the website. It is a publicly
        available website that provides a list of resources participants may use, if needed. For
        example, this will include youth mental health organizations and organizations that provide
        education, support, and advocacy for youth who have experienced cyberbullying.
  
        Social Media Data Collection and Feedback. Youth in both groups (Flourish+questionnaires and
        Questionnaires Alone) will have the option to provide their social media archives as part of
        the study. Software will strip identifiable information (e.g., names, dates of birth,
        locations, etc.) to the extent possible from the archives. Archives will be analyzed using
        software that detects presence of positive and negative social interactions. Those assigned
        to Flourish+Questionnaires will receive feedback from their online interactions, which is
        anticipated to help youth gain recognition and awareness of their online environment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study design is a randomized controlled trial.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Recruitment rates of eligible participants
  time frame: Assessed upon recruitment to the study
  description: Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.
  measure: Retention rates of eligible participants
  time frame: Assessed upon completion of the Week 12 study visits
  description: Feasibility will be measured through retention rates of eligible participants, using a cut-off score of 80% for desirable retention rates across the 12-week study period.
  measure: Level of intervention usage
  time frame: Assessed upon completion of the 4-week intervention period
  description: Usage of the intervention will be assessed by engagement with the text messaging intervention one or more times during the study period. A cut-off score of 70% of youth using the intervention one or more times will be used as a minimum requirement for acceptable usage.
  measure: Change in psychological distress from baseline to 4 weeks
  time frame: Assessed at the baseline and Week 4 follow-up assessment visits
  description: Psychological distress will be measured by the Kessler 6-item psychological distress scale (K6). Total scale scores range from 0 to 24 with higher values indicating higher levels of distress and lower values indicating lower distress.
  measure: Change in psychological distress from baseline to 12 weeks
  time frame: Assessed at the Week 12 follow-up assessment visits
  description: Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.
  measure: Change in severity of suicidal ideation and behavior from baseline to 4 weeks
  time frame: Assessed at baseline and Week 4 follow-up assessment visits
  description: Severity of suicidal ideation and behavior will be measured with the Columbia Suicide Severity Rating Scale (C-SSRS), an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.
  measure: Change in severity of suicidal ideation and behavior from baseline to 12 weeks
  time frame: Assessed at baseline and Week 12 follow-up assessment visits
  description: Severity of suicidal ideation and behavior will be measured with the C-SSRS, an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.
  measure: Change in suicidal ideation from baseline to 4 weeks
  time frame: Assessed at the baseline and Week 4 assessment visits
  description: Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire (SIQ). The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.
  measure: Change in suicidal ideation from baseline to 12 weeks
  time frame: Assessed at the baseline and Week 12 Follow-up assessment visits
  description: Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire. The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.
  measure: Change in distress tolerance from baseline to 4 weeks
  time frame: Assessed at the baseline and Week 4 assessment visits
  description: Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.
  measure: Change in distress tolerance from baseline to 12 weeks
  time frame: Assessed at the baseline and Week 12 assessment visit
  description: Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.
  measure: Change in motivation for help-seeking from baseline to 4 weeks
  time frame: Assessed at the baseline and Week 4 assessment visits
  description: Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).
  measure: Change in motivation for help-seeking from baseline to 12 weeks
  time frame: Assessed at the baseline and Week 12 follow-up assessment visits
  description: Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).
  measure: Change in social problem-solving from baseline to 4 weeks
  time frame: Assessed at baseline and Week 4 assessment visits
  description: Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.
  measure: Change in social problem-solving from baseline to 12 weeks
  time frame: Assessed at the baseline and Week 12 assessment visits
  description: Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.
  arm group label: Flourish + Questionnaires
  arm group type: Experimental
  description: Participants will be onboarded to Flourish by a research study clinician, following which they will receive a text messaging program for 4 weeks as well as an accompanying resources website. As part of the text messaging program, participants will receive brief questionnaires evaluating their online experiences once every 3 days.
  arm group label: Questionnaires Alone
  arm group type: Active Comparator
  description: Participants will be onboarded to a text message program that solely will send participants brief questionnaires evaluating their online experiences once every 3 days.
  intervention type: Behavioral
  intervention name: Flourish
  description: Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
  arm group label: Flourish + Questionnaires
  intervention type: Behavioral
  intervention name: Questionnaires of Online Experiences
  description: Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.
  arm group label: Flourish + Questionnaires
  arm group label: Questionnaires Alone
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Candice L Biernesser, PhD
  role: Principal Investigator
  affiliation: University of Pittsburgh
  last name: Candice L Biernesser, PhD
  phone: 412-586-9064
  email: lubbertcl@upmc.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Candice Biernesser
  investigator title: Assistant Professor of Psychiatry
  mesh term: Suicide
  mesh term: Suicidal Ideation
  mesh term: Suicide Prevention
  sharing ipd: Yes
  ipd description: De-identified data from enrolled participants may be shared with investigators within and outside of the University of Pittsburgh and University of Pittsburgh Medical Center for the purpose of studying cyberbullying or suicide risk among adolescents. Data sharing will be consistent with International Committee of Medical Journal Editors (ICMJE) requirements.
  ipd info type: Study Protocol
  ipd time frame: These data will be released following acceptance of the project's main outcomes manuscript.
  ipd access criteria: Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.