<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/NCT04489485</url>
  </required_header>
  <id_info>
    <org_study_id>R44MH116751</org_study_id>
    <secondary_id>1R44MH116751-01A1</secondary_id>
    <nct_id>NCT04489485</nct_id>
  </id_info>
  <brief_title>Online System for Identifying and Addressing Teen Depression in Primary Care</brief_title>
  <acronym>Depression</acronym>
  <official_title>Online System for Identifying and Addressing Teen Depression in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Total Child Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foresight Logic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Total Child Health, Inc.</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>
      A novel web-based module (Teen Depression Module or TDM)has been created for assisting&#xD;
      primary care providers (PCPs) in screening for and addressing and referring teens with&#xD;
      depression. This is a cluster randomized Quality Improvement study to determine if use of the&#xD;
      TDM that includes collecting information on strengths and goals as part of well child care&#xD;
      will improve detection of depression, referral success, and teen's use of alternative helping&#xD;
      strategies with resulting improvement in depression symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase II Summary for finalizing and testing the CHADIS Teen Depression Module (TDM) These&#xD;
      aims are unchanged except that health screening visits may be in-person or conducted via&#xD;
      telehealth.&#xD;
&#xD;
      II-1. Revise programming and training materials: TDM- an addition for primary care screening&#xD;
      and care for teen depression as part of the Comprehensive Health and Decision Information&#xD;
      System (CHADIS) online questionnaire delivery system with decision support including&#xD;
      &quot;motivational interviewing teleprompters&quot;, care coordination functionality for referrals, and&#xD;
      text chats- will be revised and programmed as needed to adjust for Phase 1 feedback and&#xD;
      training materials created.&#xD;
&#xD;
      II-2 Recruit 20 study PCP's, set up care coordination with MH specialists and assess:&#xD;
      Investigators will recruit 20 primary care providers (PCPs), assuring representative&#xD;
      Medicaid-insured teens, and randomize to intervention or control. Intervention PCPs will&#xD;
      identify their local Mental Health (MH) resources to recruit for referrals and use of care&#xD;
      coordination functionality. 2 Therapists, 2 PCPs, and 2 Psychiatrists (Psy) using the care&#xD;
      coordination will give feedback on functionality, acceptability and likelihood of continued&#xD;
      use as well as use of a text messaging robot messaging about referrals after the baseline.&#xD;
      Investigators will document current PCP access to MH services.&#xD;
&#xD;
      II-3 Baseline (3 mo.), refine implementation strategies using QI Maintenance of Certification&#xD;
      (MOC-4) sessions:&#xD;
&#xD;
      All 20 PCPs will use the Patient Health Questionnaire-9 (PHQ-9) for depression (without&#xD;
      follow-up questions) for a baseline, and have implementation issues addressed using Quality&#xD;
      Improvement (QI) methods. Data will be collected from teens and parents before in person or&#xD;
      telehealth Health Supervision Visits (HSV) using CHADIS. Data on rates of depression&#xD;
      screening using CHADIS and billing data will be shared with PCPs as part of Maintenance of&#xD;
      Certification Part 4 (MOC-4) sessions for intervention and controls. Teens (&lt;=480) will be&#xD;
      sent a text survey post visit of any strength- or emotion- supporting care received.&#xD;
&#xD;
      II-4 Create child psychiatry version of TDM: Denver team will modify TDM for Psy including&#xD;
      care plans.&#xD;
&#xD;
      II-5 Obtain MOC-4 approval for child psychiatry by American Board of Medical Specialties&#xD;
      (covering American Board of Psychiatry and Neurology) for Child Psychiatrists for use of the&#xD;
      TDM created in II-4 and MOC-4 will be offered to participating Child Psychiatrists.&#xD;
&#xD;
      II-6 Intervention trial: (See Figure) Primary Question 1 (PQ1). For teens PHQ positive, does&#xD;
      TDM use result in lower Short Mood &amp; Feelings Questionnaire (SMFQ) scores at 3-, 6-and&#xD;
      11.5-months vs at start of intervention? Primary Question 2. For teens PHQ positive, does TDM&#xD;
      use result in lower teen and parent SMFQ scores at 3-, 6-and 11.5-months vs controls?&#xD;
      Secondary Question 1 (SQ1): Of teens PHQ positive, does TDM use result in higher rates of&#xD;
      accessing treatment at 3-, 6-and 11.5 months vs controls? Secondary Question 2. Does QI&#xD;
      method increase rates of teens screened? Secondary Question 3. Does QI method increase rates&#xD;
      of Ask Suicide Questions (ASQ) screening? Design: A cluster randomized trial with a 2-group&#xD;
      pretest-posttest design clustered at the PCP level will determine pre-post differences within&#xD;
      patients and intervention vs control group differences.&#xD;
&#xD;
      Sample size estimates consider the design effect and use an Intent to Treat model. Sample&#xD;
      sizes of 107/PCP in both intervention and control will achieve 89.5% power to detect a&#xD;
      difference between group means of &gt;=2; also sufficient power for Secondary Questions 1-3.&#xD;
      Procedure: Both groups: All teens before HSV will do: Visit Priorities, Teen Health &amp; Goals&#xD;
      comprehensive of standard guidelines, and PHQ-9 with follow up to SMFQ, if positive and get&#xD;
      health information chats with links to education/advice in their CHADIS Care Portal. All&#xD;
      parents will do Visit Priorities and Pediatric Symptom Checklist-17 (PSC) for behavior/mood&#xD;
      with follow-up parent SMFQ if the internalizing subscale is positive and can access&#xD;
      &quot;handouts&quot; in the parent Care Portal. All PCPs see questionnaire results and earn MOC-4.&#xD;
      Intervention group: Teens: will do: goals/strengths/values and ASQ. If PHQ-9 is &gt;=8 they will&#xD;
      get follow-up questions and SMFQ. Teens will get follow-up text message robot dialogues with&#xD;
      topic based on if a referral was accepted and other priorities. Chats may encourage strengths&#xD;
      and provide resources, goals, mindfulness apps, journaling or depression-Cognitive Behavior&#xD;
      Therapy dialogues for PHQ positive teens. Parents: get resources. PCPs: will use TDM results&#xD;
      and decision support to detect, educate on depression, and motivate for intervention. They&#xD;
      earn MOC.&#xD;
&#xD;
      Follow Up Measures: All teens and parents: get email/text reminders to do questionnaires 3, 6&#xD;
      and 11.5 months (pre next HSV) after initial HSV. Teens positive on initial PHQ-9 in both&#xD;
      groups will be paid (and called) to do a repeat PHQ-9 with follow-up about interval treatment&#xD;
      and parents will do SMFQ and provide impressions of PCP management and success of any&#xD;
      referrals. Rates for Ask Suicide Screening Questions (ASSQ) will be in the intervention group&#xD;
      only, as it is not usual care, but any PCP may use it. Evaluation will include: depression&#xD;
      screening rates, decision support use, proportions of positive teens referred via care&#xD;
      coordination and teen use of resources.&#xD;
&#xD;
      II.7 Analysis of Results of Intervention: Initial: Descriptive analyses. Primary Questions&#xD;
      1&amp;2: t-tests adjusted for design effect, categorical statistical tests of inference&#xD;
      appropriately matched to the underlying distributions of the measures used at T1 and T2,&#xD;
      adjusted for design. Secondary Question 2: Chi-Squared Test of Independence on two&#xD;
      cross-sectional samples tabulated at T0 and T1. Rates of ASQ use will be assessed for T2-T3.&#xD;
      Tests will be applied to 2 cross-sectional samples regardless of treatment arm. Multi-Level&#xD;
      Linear Regression models for Primary Questions 1-2 and Logistic Regression models for&#xD;
      Secondary Questions 1-3 will assess impact of patient characteristics and item responses, and&#xD;
      control for design effect of a cluster-randomized design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Short Moods and Feelings Questionnaire</measure>
    <time_frame>Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months</time_frame>
    <description>A brief screen of depressed mood completed by teen, 0-26 with 26 worst</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Short Moods and Feelings Questionnaire- Parent version</measure>
    <time_frame>Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months</time_frame>
    <description>A brief screen of depressed mood completed by parent, 0-26 with 26 worst</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self report of treatment access</measure>
    <time_frame>Day 1 well visit when there is a positive depression screen, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months</time_frame>
    <description>Teen report of depression treatment access, accessed or not accessed with accessed considered better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Entire study period of up to 3 years</time_frame>
    <description>Numbers of teens screened with PHQ-9 for depression. This outcome is not the score of the tool but numbers completing the tool with range 0-2600 with higher better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ask Suicide Screening Questions (ASSQ)</measure>
    <time_frame>Entire study period of up to 3 years</time_frame>
    <description>Numbers of teens screened with ASSQ for suicidal ideation, scores 0-8 with higher worst. This Outcome is number screened with range 0-2600 with higher better.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">580</enrollment>
  <condition>Major Depression</condition>
  <condition>Dysthymia</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Primary Care Providers (PCP)</arm_group_label>
    <description>20 PCP who provide well child care to teens 12-18. After randomization, 10 PCPs in the enhanced care group will use the Teen Depression Module for care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care teens</arm_group_label>
    <description>All teens coming for routine well child care to the control group PCPs will have routine depression screening and Youth Health Questionnaire without goals to inform treatment as usual. They will be offered a goals text messaging conversation. Suicide screening will be at the discretion of the PCP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced care teens</arm_group_label>
    <description>All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, as well as Youth Health Questionnaire with goals and then they will receive treatment guided by the Teen Depression Module and offered a depression text messaging conversation. Suicide screening will be conducted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care- caregivers</arm_group_label>
    <description>All caregivers of teens &lt;18 years old coming for routine well child care to the control group PCPs will complete a Pediatric Symptom Checklist and Short Moods and Feelings Questionnaire, plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced care- caregivers</arm_group_label>
    <description>All caregivers of teens &lt;18 years old coming for routine well child care to the enhanced group PCPs will complete a Pediatric Symptom Checklist plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Teen Depression Module used for care</intervention_name>
    <description>All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, and treatment using the Teen Depression Module and offered a depression chabot. Suicide screening will be conducted.</description>
    <arm_group_label>Enhanced care teens</arm_group_label>
    <arm_group_label>Primary Care Providers (PCP)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All teens coming to participating PCPs for well child visits during the study period and&#xD;
        their adult caregivers for those under 18&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking teens&#xD;
&#xD;
          -  English speaking caregivers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non English speaking teens&#xD;
&#xD;
          -  Non English speaking caregivers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara J Howard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Total Child Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raymond A Sturner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Promotion of Child Development</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marianne Wamboldt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>U Colorado Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barbara Howard, MD</last_name>
    <phone>4436189104</phone>
    <email>bhoward@chadis.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kerry A Bet, MPH</last_name>
    <phone>8884242347</phone>
    <email>kbet@chadis.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Total Child Health</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara J Howard, MD</last_name>
      <phone>443-618-9104</phone>
      <email>bhoward@chadis.com</email>
    </contact>
    <contact_backup>
      <last_name>Kerry A Bet, MPH</last_name>
      <phone>8884242347</phone>
      <email>kbet@chadis.com</email>
    </contact_backup>
    <investigator>
      <last_name>Paul Bergmann</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Genevive Vullo, MHS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kerry Bet, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dawn Lewis, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aimee Sullivan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Cypress, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Melissa Batt, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amy Lopez</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yidan Cao, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 20, 2022</last_update_submitted>
  <last_update_submitted_qc>March 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Total Child Health, Inc.</investigator_affiliation>
    <investigator_full_name>Barbara Howard, MD</investigator_full_name>
    <investigator_title>President of Total Child Health</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Dysthymic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of results de-identified data may be available to qualified researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 6 months after results are published.</ipd_time_frame>
    <ipd_access_criteria>Qualified medical or mental health researchers.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT04489485/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04489485
org study id: R44MH116751
secondary id: 1R44MH116751-01A1
nct id: NCT04489485
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A novel web-based module (Teen Depression Module or TDM)has been created for assisting
      primary care providers (PCPs) in screening for and addressing and referring teens with
      depression. This is a cluster randomized Quality Improvement study to determine if use of the
      TDM that includes collecting information on strengths and goals as part of well child care
      will improve detection of depression, referral success, and teen's use of alternative helping
      strategies with resulting improvement in depression symptoms.
Phase II Summary for finalizing and testing the CHADIS Teen Depression Module (TDM) These
      aims are unchanged except that health screening visits may be in-person or conducted via
      telehealth.

      II-1. Revise programming and training materials: TDM- an addition for primary care screening
      and care for teen depression as part of the Comprehensive Health and Decision Information
      System (CHADIS) online questionnaire delivery system with decision support including
      "motivational interviewing teleprompters", care coordination functionality for referrals, and
      text chats- will be revised and programmed as needed to adjust for Phase 1 feedback and
      training materials created.

      II-2 Recruit 20 study PCP's, set up care coordination with MH specialists and assess:
      Investigators will recruit 20 primary care providers (PCPs), assuring representative
      Medicaid-insured teens, and randomize to intervention or control. Intervention PCPs will
      identify their local Mental Health (MH) resources to recruit for referrals and use of care
      coordination functionality. 2 Therapists, 2 PCPs, and 2 Psychiatrists (Psy) using the care
      coordination will give feedback on functionality, acceptability and likelihood of continued
      use as well as use of a text messaging robot messaging about referrals after the baseline.
      Investigators will document current PCP access to MH services.

      II-3 Baseline (3 mo.), refine implementation strategies using QI Maintenance of Certification
      (MOC-4) sessions:

      All 20 PCPs will use the Patient Health Questionnaire-9 (PHQ-9) for depression (without
      follow-up questions) for a baseline, and have implementation issues addressed using Quality
      Improvement (QI) methods. Data will be collected from teens and parents before in person or
      telehealth Health Supervision Visits (HSV) using CHADIS. Data on rates of depression
      screening using CHADIS and billing data will be shared with PCPs as part of Maintenance of
      Certification Part 4 (MOC-4) sessions for intervention and controls. Teens (<=480) will be
      sent a text survey post visit of any strength- or emotion- supporting care received.

      II-4 Create child psychiatry version of TDM: Denver team will modify TDM for Psy including
      care plans.

      II-5 Obtain MOC-4 approval for child psychiatry by American Board of Medical Specialties
      (covering American Board of Psychiatry and Neurology) for Child Psychiatrists for use of the
      TDM created in II-4 and MOC-4 will be offered to participating Child Psychiatrists.

      II-6 Intervention trial: (See Figure) Primary Question 1 (PQ1). For teens PHQ positive, does
      TDM use result in lower Short Mood & Feelings Questionnaire (SMFQ) scores at 3-, 6-and
      11.5-months vs at start of intervention? Primary Question 2. For teens PHQ positive, does TDM
      use result in lower teen and parent SMFQ scores at 3-, 6-and 11.5-months vs controls?
      Secondary Question 1 (SQ1): Of teens PHQ positive, does TDM use result in higher rates of
      accessing treatment at 3-, 6-and 11.5 months vs controls? Secondary Question 2. Does QI
      method increase rates of teens screened? Secondary Question 3. Does QI method increase rates
      of Ask Suicide Questions (ASQ) screening? Design: A cluster randomized trial with a 2-group
      pretest-posttest design clustered at the PCP level will determine pre-post differences within
      patients and intervention vs control group differences.

      Sample size estimates consider the design effect and use an Intent to Treat model. Sample
      sizes of 107/PCP in both intervention and control will achieve 89.5% power to detect a
      difference between group means of >=2; also sufficient power for Secondary Questions 1-3.
      Procedure: Both groups: All teens before HSV will do: Visit Priorities, Teen Health & Goals
      comprehensive of standard guidelines, and PHQ-9 with follow up to SMFQ, if positive and get
      health information chats with links to education/advice in their CHADIS Care Portal. All
      parents will do Visit Priorities and Pediatric Symptom Checklist-17 (PSC) for behavior/mood
      with follow-up parent SMFQ if the internalizing subscale is positive and can access
      "handouts" in the parent Care Portal. All PCPs see questionnaire results and earn MOC-4.
      Intervention group: Teens: will do: goals/strengths/values and ASQ. If PHQ-9 is >=8 they will
      get follow-up questions and SMFQ. Teens will get follow-up text message robot dialogues with
      topic based on if a referral was accepted and other priorities. Chats may encourage strengths
      and provide resources, goals, mindfulness apps, journaling or depression-Cognitive Behavior
      Therapy dialogues for PHQ positive teens. Parents: get resources. PCPs: will use TDM results
      and decision support to detect, educate on depression, and motivate for intervention. They
      earn MOC.

      Follow Up Measures: All teens and parents: get email/text reminders to do questionnaires 3, 6
      and 11.5 months (pre next HSV) after initial HSV. Teens positive on initial PHQ-9 in both
      groups will be paid (and called) to do a repeat PHQ-9 with follow-up about interval treatment
      and parents will do SMFQ and provide impressions of PCP management and success of any
      referrals. Rates for Ask Suicide Screening Questions (ASSQ) will be in the intervention group
      only, as it is not usual care, but any PCP may use it. Evaluation will include: depression
      screening rates, decision support use, proportions of positive teens referred via care
      coordination and teen use of resources.

      II.7 Analysis of Results of Intervention: Initial: Descriptive analyses. Primary Questions
      1&2: t-tests adjusted for design effect, categorical statistical tests of inference
      appropriately matched to the underlying distributions of the measures used at T1 and T2,
      adjusted for design. Secondary Question 2: Chi-Squared Test of Independence on two
      cross-sectional samples tabulated at T0 and T1. Rates of ASQ use will be assessed for T2-T3.
      Tests will be applied to 2 cross-sectional samples regardless of treatment arm. Multi-Level
      Linear Regression models for Primary Questions 1-2 and Logistic Regression models for
      Secondary Questions 1-3 will assess impact of patient characteristics and item responses, and
      control for design effect of a cluster-randomized design.
observational model: Case-Control
time perspective: Prospective
measure: Change in Short Moods and Feelings Questionnaire
time frame: Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
description: A brief screen of depressed mood completed by teen, 0-26 with 26 worst
measure: Change in Short Moods and Feelings Questionnaire- Parent version
time frame: Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
description: A brief screen of depressed mood completed by parent, 0-26 with 26 worst
measure: Change in Self report of treatment access
time frame: Day 1 well visit when there is a positive depression screen, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
description: Teen report of depression treatment access, accessed or not accessed with accessed considered better
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: Entire study period of up to 3 years
description: Numbers of teens screened with PHQ-9 for depression. This outcome is not the score of the tool but numbers completing the tool with range 0-2600 with higher better.
measure: Ask Suicide Screening Questions (ASSQ)
time frame: Entire study period of up to 3 years
description: Numbers of teens screened with ASSQ for suicidal ideation, scores 0-8 with higher worst. This Outcome is number screened with range 0-2600 with higher better.
arm group label: Primary Care Providers (PCP)
description: 20 PCP who provide well child care to teens 12-18. After randomization, 10 PCPs in the enhanced care group will use the Teen Depression Module for care.
arm group label: Standard care teens
description: All teens coming for routine well child care to the control group PCPs will have routine depression screening and Youth Health Questionnaire without goals to inform treatment as usual. They will be offered a goals text messaging conversation. Suicide screening will be at the discretion of the PCP.
arm group label: Enhanced care teens
description: All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, as well as Youth Health Questionnaire with goals and then they will receive treatment guided by the Teen Depression Module and offered a depression text messaging conversation. Suicide screening will be conducted.
arm group label: Standard care- caregivers
description: All caregivers of teens <18 years old coming for routine well child care to the control group PCPs will complete a Pediatric Symptom Checklist and Short Moods and Feelings Questionnaire, plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)
arm group label: Enhanced care- caregivers
description: All caregivers of teens <18 years old coming for routine well child care to the enhanced group PCPs will complete a Pediatric Symptom Checklist plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)
intervention type: Behavioral
intervention name: Teen Depression Module used for care
description: All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, and treatment using the Teen Depression Module and offered a depression chabot. Suicide screening will be conducted.
arm group label: Enhanced care teens
arm group label: Primary Care Providers (PCP)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara J Howard, MD
role: Principal Investigator
affiliation: Total Child Health
last name: Raymond A Sturner, MD
role: Principal Investigator
affiliation: Center for Promotion of Child Development
last name: Marianne Wamboldt, MD
role: Principal Investigator
affiliation: U Colorado Medical Center
last name: Barbara Howard, MD
phone: 4436189104
email: bhoward@chadis.com
last name: Kerry A Bet, MPH
phone: 8884242347
email: kbet@chadis.com
facility: 
status: Recruiting
contact: 
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country: United States
responsible party type: Principal Investigator
investigator affiliation: Total Child Health, Inc.
investigator full name: Barbara Howard, MD
investigator title: President of Total Child Health
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Dysthymic Disorder
sharing ipd: Yes
ipd description: After publication of results de-identified data may be available to qualified researchers.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 6 months after results are published.
ipd access criteria: Qualified medical or mental health researchers.
provided document: 