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/NCT06004414</url>
    </required_header>
    <id_info>
      <org_study_id>23-00257</org_study_id>
      <nct_id>NCT06004414</nct_id>
    </id_info>
    <brief_title>SilverCloud as a School-Based Intervention for Vulnerable Youth</brief_title>
    <official_title>Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</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>NYU Langone Health</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to test the efficacy and feasibility of a clinician-guided,&#xD;
        app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental&#xD;
        health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to&#xD;
        determine preliminary efficacy in this sample and inform program refinements by collecting&#xD;
        outcome self-report assessments and conducting interviews on feasibility and acceptability.&#xD;
        After the program and its implementation strategy are refined, we will conduct an randomized&#xD;
        controlled trial. Adolescents who screen positive for significant mental health symptoms and&#xD;
        who are enrolled in their school-based health center (SBHC) will be randomized to receive&#xD;
        SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome&#xD;
        self-reports. Feasibility and acceptability feedback will again be collected from&#xD;
        participants, SBHC staff, and community members.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Patient Health Questionnaire-9 (PHQ-9) Score</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in General Anxiety Disorder-7 (GAD-7) Score</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>The RCADS-25 is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. Each item is rated as 0 (never), 1 (sometimes), 2 (often), or 3 (always). The raw score is the sum of responses and is converted to a T-score where: below 65 = normal range; between 65-69 = borderline clinical range; and 70 above = clinical range.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>This is an 8-item questionnaire assessing pediatric peer relationships. Each item is rated on a scale from 1 (never) to 5 (almost always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger peer relationships.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>This is an 8-item questionnaire assessing pediatric family relationships. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger family relationships.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>This is an 8-item questionnaire assessing pediatric sleep disturbance. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more prevalent sleep disturbance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in School Engagement Scale Score</measure>
      <time_frame>Baseline, Week 8</time_frame>
      <description>23-item questionnaire assessing engagement in school. Each item is rated on a 6-point scale ranging from 1-5. The total score is the sum of responses and ranges from 23 to 115. Higher scores indicate greater school engagement.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>SilverCloud</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive SilverCloud.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive psychotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>App-based Cognitive Behavioral Therapy (CBT)</intervention_name>
      <description>SilverCloud is organized into eight core modules that follow evidence-based principles of CBT, along with six additional modules that can be prescribed by the clinician to address a participant's specific needs.</description>
      <arm_group_label>SilverCloud</arm_group_label>
      <other_name>SilverCloud</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychotherapy</intervention_name>
      <description>Psychotherapy with a licensed clinician in the school-based health center.</description>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in the phase I open trial of this study, an&#xD;
          individual must meet all of the following criteria:&#xD;
  &#xD;
            -  Enrolled in the SBHC at the high school&#xD;
  &#xD;
            -  Score of 10+ on GAD-7 or PHQ-9&#xD;
  &#xD;
            -  Speak/read English. The current investigational version of SilverCloud that will be&#xD;
               used in this study is only available in English.&#xD;
  &#xD;
          In order to be eligible to participate in the RCT of this study, an individual must meet&#xD;
          all of the following criteria:&#xD;
  &#xD;
            -  Enrolled in 9th through 11th grades.&#xD;
  &#xD;
            -  Score of 10+ on GAD-7 or PHQ-9&#xD;
  &#xD;
            -  Enrolled in the SBHC at the high school&#xD;
  &#xD;
            -  Speak/read English. The current investigational version of SilverCloud that will be&#xD;
               used in this study is only available in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in the phase I open trial of this study:&#xD;
  &#xD;
            -  Current (within 1 month of enrollment) mental health treatment at the SBHC&#xD;
  &#xD;
            -  Does not use a smartphone&#xD;
  &#xD;
            -  Mental health concerns for which intensive treatment is indicated. Because SilverCloud&#xD;
               has not been evaluated in people with serious mental illness, participants who exhibit&#xD;
               symptoms of mania or psychosis will be referred to a higher level of care.&#xD;
  &#xD;
            -  Current suicidal ideation with intent. Participants who have a suicide plan and intent&#xD;
               to act on it will be referred to the SBHC suicide risk protocol and will not be&#xD;
               eligible until their suicidal thoughts have abated.&#xD;
  &#xD;
          An individual who meets any of the following criteria will be excluded from participation&#xD;
          in the RCT of this study:&#xD;
  &#xD;
            -  Current (within 1 month of enrollment) mental health treatment at the SBHC&#xD;
  &#xD;
            -  Does not use a smartphone&#xD;
  &#xD;
            -  Mental health concerns for which intensive treatment is indicated. Because SilverCloud&#xD;
               has not been evaluated in people with serious mental illness, participants who exhibit&#xD;
               symptoms of mania or psychosis will be referred to a higher level of care.&#xD;
  &#xD;
            -  Current suicidal ideation with intent. Participants who have a suicide plan and intent&#xD;
               to act on it will be referred to the SBHC suicide risk protocol and will not be&#xD;
               eligible until their suicidal thoughts have abated.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>22 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna Van Meter, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Erum Nadeem, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rutgers University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna Van Meter, PhD</last_name>
      <phone>646-754-5085</phone>
      <email>anna.vanmeter@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erum Nadeem, PhD</last_name>
      <email>Erum.nadeem@rutgers.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>depression</keyword>
    <keyword>anxiety</keyword>
    <keyword>behavioral therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the NIMH Data Archive. Data will be made available following article publication or as required by a condition of awards and agreements supporting the research. Data are available indefinitely through the NIMH Data Archive. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by the NIMH Data Archive will be shared to achieve aims in the approved proposal. Data are available indefinitely through the NIMH Data Archive.</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/NCT06004414
  org study id: 23-00257
  nct id: NCT06004414
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The goal of this study is to test the efficacy and feasibility of a clinician-guided,
        app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental
        health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to
        determine preliminary efficacy in this sample and inform program refinements by collecting
        outcome self-report assessments and conducting interviews on feasibility and acceptability.
        After the program and its implementation strategy are refined, we will conduct an randomized
        controlled trial. Adolescents who screen positive for significant mental health symptoms and
        who are enrolled in their school-based health center (SBHC) will be randomized to receive
        SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome
        self-reports. Feasibility and acceptability feedback will again be collected from
        participants, SBHC staff, and community members.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
  time frame: Baseline, Week 8
  description: The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.
  measure: Change in General Anxiety Disorder-7 (GAD-7) Score
  time frame: Baseline, Week 8
  description: The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.
  measure: Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score
  time frame: Baseline, Week 8
  description: The RCADS-25 is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. Each item is rated as 0 (never), 1 (sometimes), 2 (often), or 3 (always). The raw score is the sum of responses and is converted to a T-score where: below 65 = normal range; between 65-69 = borderline clinical range; and 70 above = clinical range.
  measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score
  time frame: Baseline, Week 8
  description: This is an 8-item questionnaire assessing pediatric peer relationships. Each item is rated on a scale from 1 (never) to 5 (almost always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger peer relationships.
  measure: Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a
  time frame: Baseline, Week 8
  description: This is an 8-item questionnaire assessing pediatric family relationships. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger family relationships.
  measure: Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a
  time frame: Baseline, Week 8
  description: This is an 8-item questionnaire assessing pediatric sleep disturbance. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more prevalent sleep disturbance.
  measure: Change in School Engagement Scale Score
  time frame: Baseline, Week 8
  description: 23-item questionnaire assessing engagement in school. Each item is rated on a 6-point scale ranging from 1-5. The total score is the sum of responses and ranges from 23 to 115. Higher scores indicate greater school engagement.
  arm group label: SilverCloud
  arm group type: Experimental
  description: Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive SilverCloud.
  arm group label: Treatment as Usual (TAU)
  arm group type: Active Comparator
  description: Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive psychotherapy.
  intervention type: Behavioral
  intervention name: App-based Cognitive Behavioral Therapy (CBT)
  description: SilverCloud is organized into eight core modules that follow evidence-based principles of CBT, along with six additional modules that can be prescribed by the clinician to address a participant's specific needs.
  arm group label: SilverCloud
  other name: SilverCloud
  intervention type: Behavioral
  intervention name: Psychotherapy
  description: Psychotherapy with a licensed clinician in the school-based health center.
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 22 Years
  healthy volunteers: No
  last name: Anna Van Meter, PhD
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Erum Nadeem, PhD
  role: Principal Investigator
  affiliation: Rutgers University
  last name: Anna Van Meter, PhD
  phone: 646-754-5085
  email: anna.vanmeter@nyulangone.org
  last name: Erum Nadeem, PhD
  email: Erum.nadeem@rutgers.edu
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the NIMH Data Archive. Data will be made available following article publication or as required by a condition of awards and agreements supporting the research. Data are available indefinitely through the NIMH Data Archive. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Immediately following publication. No end date.
  ipd access criteria: Investigators whose proposed use of the data has been approved by the NIMH Data Archive will be shared to achieve aims in the approved proposal. Data are available indefinitely through the NIMH Data Archive.