<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/NCT03034720</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000437</org_study_id>
    <nct_id>NCT03034720</nct_id>
  </id_info>
  <brief_title>Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth</brief_title>
  <official_title>Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seattle Children's Hospital</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>
      SPECIFIC AIMS&#xD;
&#xD;
      While post-concussive symptoms following sports-related concussion are typically transient&#xD;
      and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who&#xD;
      sustain concussion experience significant morbidity that can persist well beyond the normal&#xD;
      disease course.Furthermore, post-concussive symptoms commonly co-occur with affective&#xD;
      symptoms including depression and anxiety which when present can prolong recovery from&#xD;
      primary post-concussive symptoms. Together, persistent physical and psychological symptoms&#xD;
      confer protracted functional impairment and create a significant burden for affected youth,&#xD;
      their family, and school. Currently, there are no evidence-based guidelines to inform&#xD;
      treatment of persistent post-concussive symptoms in youth and adolescents.&#xD;
&#xD;
      In response to the dearth of evidence-based treatment approaches for youth with persistent&#xD;
      post-concussive symptoms, the investigators developed a novel collaborative care treatment&#xD;
      model that simultaneously targets post-concussive symptoms and co-occurring depression and&#xD;
      anxiety. Athletes and their family members receive patient navigator care management services&#xD;
      that bridge post-injury care across acute care, specialist and primary care health service&#xD;
      delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain&#xD;
      symptomatic after initial treatment efforts receive stepped-up care that may include&#xD;
      psychopharmacologic consultation. The Investigators have demonstrated feasibility of the&#xD;
      intervention model through a pilot randomized-control trial of 49 adolescents with persistent&#xD;
      post-concussive symptoms recruited from a regional children's hospital. Participants assigned&#xD;
      to the intervention condition demonstrated significant and clinically-meaningful reductions&#xD;
      in post-concussive and depressive symptoms as well as health-related quality of life as&#xD;
      compared to adolescents in the usual care arm of the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will expand upon the pilot trial in order to further develop, implement,&#xD;
      and test the impact of an innovative collaborative care approach tailored to the needs of a&#xD;
      patient population who currently have no evidence-based options. The investigators propose a&#xD;
      broad reach intervention strategy that is designed to be readily implemented in acute,&#xD;
      specialty and primary care medical settings, as well as over the telephone. The investigators&#xD;
      will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,&#xD;
      suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related&#xD;
      injury. Athletes will be randomized to collaborative care (intervention) or post-sports&#xD;
      injury care as usual (control group) conditions. The study is designed with the following&#xD;
      aims:&#xD;
&#xD;
      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in&#xD;
      reducing post-concussive and co-occurring psychological symptoms in youth with persistent&#xD;
      post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative&#xD;
      care intervention will demonstrate clinically and statistically significant reductions in&#xD;
      post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month&#xD;
      study, compared to usual care control group athletes Aim 2. To examine the effectiveness of&#xD;
      the intervention in improving function and health-related quality of life amongst youth with&#xD;
      persistent symptoms after sports-related concussion H2: Adolescents who receive a&#xD;
      collaborative care intervention will exhibit a clinically meaningful improvement in function&#xD;
      and health-related quality life Exploratory Aim 3. To explore differences in school&#xD;
      performance between groups H3: Adolescents who receive the collaborative care intervention&#xD;
      will receive individualized treatment and community resource linkages which will improve&#xD;
      their school performance as compared to adolescents receiving treatment as usual Aim 4. To&#xD;
      explore the heterogeneity of treatment effects in the primary and secondary outcomes by&#xD;
      examining the interaction of the treatment effect with group membership in distinct subgroups&#xD;
      of the population. H4: Three distinct subgroups are expected to emerge from the study&#xD;
      population: adolescents who recover from symptoms, adolescents with chronic psychosocial&#xD;
      problems, and adolescents whose symptoms wax and wane over time. A greater proportion of&#xD;
      adolescents who recover from symptoms will emerge in the treatment group, compared to&#xD;
      controls.&#xD;
&#xD;
      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological&#xD;
      symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral&#xD;
      health providers, the collaborative care health services intervention could accelerate the&#xD;
      rate of recovery from persistent post-concussive symptoms and attenuate the degree and&#xD;
      duration of disability during adolescence, a critical period for healthy development.&#xD;
      Validation of this treatment through a scaled up clinical trial will serve as a foundation&#xD;
      for broader dissemination of this collaborative care treatment model. The multidisciplinary&#xD;
      sports concussion research team will simultaneously work nationally and internationally to&#xD;
      ensure study results are expediently translated into effective policy for youth athletes&#xD;
      suffering from enduring symptoms and functional impairments in the wake of sports-related&#xD;
      concussions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">May 29, 2020</completion_date>
  <primary_completion_date type="Actual">May 29, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-concussive symptoms measured with the HBI</measure>
    <time_frame>During the12 months after enrollment.</time_frame>
    <description>The central hypothesis is that the two groups will have different patterns of HBI scores over time, with the intervention group showing significant. reductions when compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life as measured with the PedsQL</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
    <description>The hypothesis is that the two groups will have different patterns of PEDSQL scores over time, with the intervention group showing significant reductions when compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms measured by the PHQ-9</measure>
    <time_frame>During the12 months after enrollment.</time_frame>
    <description>The hypothesis is that the two groups will have different patterns of PHQ-9 scores over time, with the intervention group showing significant. reductions when compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms measured by the GAD-7</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
    <description>The hypothesis is that the two groups will have different patterns of GAD-7 scores over time, with the intervention group showing significant reductions when compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety symptoms measured by the RCADS</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
    <description>The hypothesis is that the two groups will have different patterns of RCADS scores over time, with the intervention group showing significant reductions when compared to controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>School performance as measured by GPA</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to full activities at school as measured by the CLASS</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
    <description>The secondary hypothesis is that the two groups will have different patterns on the CLASS over time, with the intervention group showing significant reductions when compared to controls</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Outcome Measure</measure>
    <time_frame>During the 12 months after enrollment</time_frame>
    <description>Exploratory outcome measures: Heterogeneity of treatment effects in the primary and secondary outcomes by examining interaction between treatment group and membership in distinct subgroups of the study population representing youth who recover from symptoms, youth with chronic psychosocial problems, and youth whose symptoms wax and wane over follow up.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Concussion, Brain</condition>
  <condition>TBI</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Collaborative Care</intervention_name>
    <description>Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking male and female sports-injured adolescents&#xD;
&#xD;
          -  ages 11-18&#xD;
&#xD;
          -  health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured&#xD;
             or worsened for at least 1-month but less than 9 months since injury will be included&#xD;
             in the investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be&#xD;
             excluded.&#xD;
&#xD;
          -  Adolescents whose parents report that their child has ever had a diagnosis of&#xD;
             schizophrenia or psychosis will be excluded from the study.&#xD;
&#xD;
          -  Adolescents whose parents report concerns about their child's ability to communicate&#xD;
             may be excluded from the study (pending consult with PIs).&#xD;
&#xD;
          -  Adolescents who have suffered spinal cord or other severe injuries that prevent&#xD;
             participation will be excluded from the study.&#xD;
&#xD;
               -  Adults unable to consent are not included in this research&#xD;
&#xD;
               -  Adolescents and parents who do not read and speak English will not be included&#xD;
&#xD;
               -  Wards of the state are not included in this research&#xD;
&#xD;
               -  Pregnant women are not included in this research&#xD;
&#xD;
               -  Prisoners are not included in this research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick P Rivara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Childrens Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Payne KM, Prentice ET, Marcynyszyn LA, McCarty CA. Goals for Persistent Postconcussive Symptom Treatment From Adolescent and Parent Perspectives. JAMA Pediatr. 2020 Dec 1;174(12):1210-1211. doi: 10.1001/jamapediatrics.2020.0898.</citation>
    <PMID>32391873</PMID>
  </reference>
  <reference>
    <citation>Marcynyszyn LA, McCarty CA, Rivara FP, Johnson AM, Wang J, Zatzick DF. Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms. J Pediatr Psychol. 2021 Jun 3;46(5):547-556. doi: 10.1093/jpepsy/jsaa128.</citation>
    <PMID>33411915</PMID>
  </reference>
  <reference>
    <citation>McCarty CA, Zatzick D, Hoopes T, Payne K, Parrish R, Rivara FP. Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial. Trials. 2019 Sep 18;20(1):567. doi: 10.1186/s13063-019-3662-3.</citation>
    <PMID>31533799</PMID>
  </reference>
  <reference>
    <citation>Johnson AM, McCarty CA, Marcynyszyn LA, Zatzick DF, Chrisman SP, Rivara FP. Child- compared with parent-report ratings on psychosocial measures following a mild traumatic brain injury among youth with persistent post-concussion symptoms. Brain Inj. 2021 Apr 16;35(5):574-586. doi: 10.1080/02699052.2021.1889663. Epub 2021 Mar 18.</citation>
    <PMID>33733955</PMID>
  </reference>
  <results_reference>
    <citation>McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207.</citation>
    <PMID>33635325</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>April 5, 2021</last_update_submitted>
  <last_update_submitted_qc>April 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Fred Rivara</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Concussion</keyword>
  <keyword>persistent post-concussive symptoms</keyword>
  <keyword>CBT</keyword>
  <keyword>collaborative care</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT03034720
org study id: STUDY00000437
nct id: NCT03034720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
SPECIFIC AIMS

      While post-concussive symptoms following sports-related concussion are typically transient
      and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who
      sustain concussion experience significant morbidity that can persist well beyond the normal
      disease course.Furthermore, post-concussive symptoms commonly co-occur with affective
      symptoms including depression and anxiety which when present can prolong recovery from
      primary post-concussive symptoms. Together, persistent physical and psychological symptoms
      confer protracted functional impairment and create a significant burden for affected youth,
      their family, and school. Currently, there are no evidence-based guidelines to inform
      treatment of persistent post-concussive symptoms in youth and adolescents.

      In response to the dearth of evidence-based treatment approaches for youth with persistent
      post-concussive symptoms, the investigators developed a novel collaborative care treatment
      model that simultaneously targets post-concussive symptoms and co-occurring depression and
      anxiety. Athletes and their family members receive patient navigator care management services
      that bridge post-injury care across acute care, specialist and primary care health service
      delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain
      symptomatic after initial treatment efforts receive stepped-up care that may include
      psychopharmacologic consultation. The Investigators have demonstrated feasibility of the
      intervention model through a pilot randomized-control trial of 49 adolescents with persistent
      post-concussive symptoms recruited from a regional children's hospital. Participants assigned
      to the intervention condition demonstrated significant and clinically-meaningful reductions
      in post-concussive and depressive symptoms as well as health-related quality of life as
      compared to adolescents in the usual care arm of the trial.
The proposed study will expand upon the pilot trial in order to further develop, implement,
      and test the impact of an innovative collaborative care approach tailored to the needs of a
      patient population who currently have no evidence-based options. The investigators propose a
      broad reach intervention strategy that is designed to be readily implemented in acute,
      specialty and primary care medical settings, as well as over the telephone. The investigators
      will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,
      suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related
      injury. Athletes will be randomized to collaborative care (intervention) or post-sports
      injury care as usual (control group) conditions. The study is designed with the following
      aims:

      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in
      reducing post-concussive and co-occurring psychological symptoms in youth with persistent
      post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative
      care intervention will demonstrate clinically and statistically significant reductions in
      post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month
      study, compared to usual care control group athletes Aim 2. To examine the effectiveness of
      the intervention in improving function and health-related quality of life amongst youth with
      persistent symptoms after sports-related concussion H2: Adolescents who receive a
      collaborative care intervention will exhibit a clinically meaningful improvement in function
      and health-related quality life Exploratory Aim 3. To explore differences in school
      performance between groups H3: Adolescents who receive the collaborative care intervention
      will receive individualized treatment and community resource linkages which will improve
      their school performance as compared to adolescents receiving treatment as usual Aim 4. To
      explore the heterogeneity of treatment effects in the primary and secondary outcomes by
      examining the interaction of the treatment effect with group membership in distinct subgroups
      of the population. H4: Three distinct subgroups are expected to emerge from the study
      population: adolescents who recover from symptoms, adolescents with chronic psychosocial
      problems, and adolescents whose symptoms wax and wane over time. A greater proportion of
      adolescents who recover from symptoms will emerge in the treatment group, compared to
      controls.

      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological
      symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral
      health providers, the collaborative care health services intervention could accelerate the
      rate of recovery from persistent post-concussive symptoms and attenuate the degree and
      duration of disability during adolescence, a critical period for healthy development.
      Validation of this treatment through a scaled up clinical trial will serve as a foundation
      for broader dissemination of this collaborative care treatment model. The multidisciplinary
      sports concussion research team will simultaneously work nationally and internationally to
      ensure study results are expediently translated into effective policy for youth athletes
      suffering from enduring symptoms and functional impairments in the wake of sports-related
      concussions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Post-concussive symptoms measured with the HBI
time frame: During the12 months after enrollment.
description: The central hypothesis is that the two groups will have different patterns of HBI scores over time, with the intervention group showing significant. reductions when compared to controls.
measure: Health related quality of life as measured with the PedsQL
time frame: During the 12 months after enrollment
description: The hypothesis is that the two groups will have different patterns of PEDSQL scores over time, with the intervention group showing significant reductions when compared to controls.
measure: Depressive symptoms measured by the PHQ-9
time frame: During the12 months after enrollment.
description: The hypothesis is that the two groups will have different patterns of PHQ-9 scores over time, with the intervention group showing significant. reductions when compared to controls.
measure: Anxiety symptoms measured by the GAD-7
time frame: During the 12 months after enrollment
description: The hypothesis is that the two groups will have different patterns of GAD-7 scores over time, with the intervention group showing significant reductions when compared to controls.
measure: Anxiety symptoms measured by the RCADS
time frame: During the 12 months after enrollment
description: The hypothesis is that the two groups will have different patterns of RCADS scores over time, with the intervention group showing significant reductions when compared to controls.
measure: School performance as measured by GPA
time frame: During the 12 months after enrollment
measure: Return to full activities at school as measured by the CLASS
time frame: During the 12 months after enrollment
description: The secondary hypothesis is that the two groups will have different patterns on the CLASS over time, with the intervention group showing significant reductions when compared to controls
measure: Exploratory Outcome Measure
time frame: During the 12 months after enrollment
description: Exploratory outcome measures: Heterogeneity of treatment effects in the primary and secondary outcomes by examining interaction between treatment group and membership in distinct subgroups of the study population representing youth who recover from symptoms, youth with chronic psychosocial problems, and youth whose symptoms wax and wane over follow up.
arm group label: Intervention
arm group type: Experimental
description: Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.
arm group label: Control
arm group type: No Intervention
description: Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable.
intervention type: Behavioral
intervention name: Collaborative Care
description: Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.
arm group label: Intervention
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: No
last name: Frederick P Rivara, MD
role: Principal Investigator
affiliation: Seattle Children's Research Institute
facility: 
country: United States
citation: Payne KM, Prentice ET, Marcynyszyn LA, McCarty CA. Goals for Persistent Postconcussive Symptom Treatment From Adolescent and Parent Perspectives. JAMA Pediatr. 2020 Dec 1;174(12):1210-1211. doi: 10.1001/jamapediatrics.2020.0898.
PMID: 32391873
citation: Marcynyszyn LA, McCarty CA, Rivara FP, Johnson AM, Wang J, Zatzick DF. Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms. J Pediatr Psychol. 2021 Jun 3;46(5):547-556. doi: 10.1093/jpepsy/jsaa128.
PMID: 33411915
citation: McCarty CA, Zatzick D, Hoopes T, Payne K, Parrish R, Rivara FP. Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial. Trials. 2019 Sep 18;20(1):567. doi: 10.1186/s13063-019-3662-3.
PMID: 31533799
citation: Johnson AM, McCarty CA, Marcynyszyn LA, Zatzick DF, Chrisman SP, Rivara FP. Child- compared with parent-report ratings on psychosocial measures following a mild traumatic brain injury among youth with persistent post-concussion symptoms. Brain Inj. 2021 Apr 16;35(5):574-586. doi: 10.1080/02699052.2021.1889663. Epub 2021 Mar 18.
PMID: 33733955
citation: McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207.
PMID: 33635325
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Fred Rivara
investigator title: Investigator
mesh term: Brain Concussion
mesh term: Depression