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/NCT06036147</url>
    </required_header>
    <id_info>
      <org_study_id>00004199</org_study_id>
      <secondary_id>R01HD090230</secondary_id>
      <nct_id>NCT06036147</nct_id>
    </id_info>
    <brief_title>Concussion Health Improvement Program</brief_title>
    <acronym>CHIP</acronym>
    <official_title>Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seattle Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        More than 1 million U.S. youth sustain a concussion each year, and up to 30% report&#xD;
        persistent post- concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with&#xD;
        normal adolescent development, resulting in issues with socioemotional dysfunction and even&#xD;
        school failure. Despite these concerns, few evidence based treatments are available for youth&#xD;
        with PPCS. We have conducted extensive work adapting a collaborative care framework for youth&#xD;
        with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills&#xD;
        training (PST) and care management (CM) to create wraparound treatment for youth with PPCS&#xD;
        that can be delivered either in- person or virtually. We completed an R01-funded randomized&#xD;
        controlled trial with this approach, finding effectiveness for youth with PPCS, with&#xD;
        improvements in concussive symptoms and quality of life at one year, and 60% of participants&#xD;
        completing the intervention entirely virtually. Of note, this intervention is unique in that&#xD;
        two of the components are focused on parents or parents and youth together (PST, CM), and&#xD;
        only one of the components (cf-CBT) is solely youth focused. We now propose to optimize and&#xD;
        refine this approach, conducting a high efficiency MOST (multiphase optimization strategy)&#xD;
        trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to&#xD;
        effectiveness, thereby allowing us to streamline the intervention to only include active&#xD;
        components. The analysis will be factorial, with three intervention components and two levels&#xD;
        of each (present or absent), resulting in 8 possible treatment combinations. The benefit of&#xD;
        the MOST approach is that it combines all youth who receive a component, allowing us to&#xD;
        assess all treatment components with only a modest sample size. We will recruit 374 youth&#xD;
        with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend&#xD;
        treatment sessions via video conferencing software over three months, and complete surveys&#xD;
        regarding primary outcomes (concussive symptoms and health-related quality of life) and&#xD;
        secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3/ 6 /12 months.&#xD;
        We will also assess potential mediators and moderators to allow for future tailoring and&#xD;
        refinement. At the completion of this study, we will have a completely optimized and refined&#xD;
        intervention for youth with PPCS ready for large scale implementation and dissemination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Concussion is common among adolescents, affecting up to 1.9 million U.S. youth per year.&#xD;
        Although many youth recover quickly, up to 30% experience difficulty concentrating, headache,&#xD;
        sleep disruption and other symptoms extending one month or longer, characterized as&#xD;
        persistent post-concussive symptoms (PPCS). Youth with PPCS can have symptoms for months,&#xD;
        leading to declines in academic function and quality of life, as well as excessive healthcare&#xD;
        costs. Research indicates mental health comorbidity is linked to greater likelihood of&#xD;
        prolonged concussive symptoms, however evidence regarding mental health interventions for&#xD;
        PPCS is still developing and mental health approaches are not included in the standard of&#xD;
        care. Our team successfully adapted and tested a mental health intervention for youth with&#xD;
        PPCS involving collaborative care (CC) delivery of youth concussion-focused&#xD;
        cognitive-behavioral therapy (cf-CBT), parenting skills training (PST) and care management&#xD;
        (CM), with medication guidance as needed. We completed an R01 level randomized controlled&#xD;
        trial of the CC approach for youth with PPCS, finding evidence for long-term gains; those&#xD;
        receiving CC had improvements at 12 months in concussion symptoms (Cohen's d=0.32) and&#xD;
        health-related quality of life (HRQoL) (Cohen's d=0.29) compared to usual care. Perhaps most&#xD;
        importantly, more than half of families (60%) completed the intervention entirely virtually,&#xD;
        expanding accessibility. While our multicomponent CC approach was effective, research&#xD;
        suggests duration and complexity of evidence-based mental health interventions affect the&#xD;
        likelihood of successful implementation and dissemination.&#xD;
  &#xD;
        We are now striving to optimize the CC approach by assessing the contribution of each&#xD;
        component in order to increase efficiency and scalability while maximizing effectiveness. We&#xD;
        have chosen to view the CC intervention treatment effects using the frame of the&#xD;
        Socioecological Model,16 postulating that cf-CBT targets the individual level, PST targets&#xD;
        the interpersonal level (i.e., relationships with parents) and CM targets the organizational&#xD;
        level (i.e., linkages to medical, school, and other services). We have also worked to amplify&#xD;
        each component, noting in previous trials that concussive symptoms, sleep and HRQoL improved&#xD;
        significantly in the intervention group compared to usual care, without a concomitant&#xD;
        improvement in headache.14 In response, we increased the focus on skills for managing&#xD;
        headache in the cf-CBT and PST components, with the guidance of a pain psychologist. We also&#xD;
        increased the rigor and structure of all components with greater oversight regarding delivery&#xD;
        and duration. Our next step is to assess the separate contribution of each different leveled&#xD;
        component (cf-CBT, PST and CM) to determine their impact on youth and parent outcomes.&#xD;
  &#xD;
        We propose to conduct an optimization trial with the CC approach for youth with PPCS,&#xD;
        utilizing a highly efficient analytic approach, the multiphase optimization strategy&#xD;
        (MOST).The design will be factorial, with three components (cf-CBT, PST and CM) each with two&#xD;
        levels (present or absent). We will recruit adolescents aged 11-18 with PPCS lasting at least&#xD;
        1 month from outpatient clinics, randomizing families to one of 8 groups to assess all&#xD;
        combinations of treatment components. Families will participate in sessions virtually and&#xD;
        complete surveys at 3, 6 and 12 months to measure proximal and distal outcomes. We will&#xD;
        examine potential mechanisms of action for each component and explore differential&#xD;
        effectiveness across baseline factors via moderation. We will sample youth from two distinct&#xD;
        geographic regions to enhance diversity and improve generalizability.&#xD;
  &#xD;
        Aim 1. Determine which components of the CC approach (cf-CBT, PST and CM) contribute&#xD;
        significantly to improvements in distal outcomes, particularly concussive symptoms and youth&#xD;
        HRQoL, among a diverse sample of youth with PPCS.&#xD;
  &#xD;
        1a. Examine the effect of intervention components on proximal outcomes including youth&#xD;
        headache, mood and sleep, and parental distress regarding their child's illness.&#xD;
  &#xD;
        Aim 2. Assess potential mediation of intervention component effects by postulated mechanistic&#xD;
        factors including improvements in a) youth self-efficacy, b) positive parenting behavior and&#xD;
        c) parental self-efficacy regarding navigating their child's concussion care.&#xD;
  &#xD;
        Aim 3. Explore moderation of intervention component effects by demographic (parental&#xD;
        education level, youth race/ethnicity, youth sex) and clinical factors (youth depression and&#xD;
        level of parent emotional distress).&#xD;
  &#xD;
        The proposed study will advance concussion research by continuing to refine an evidence-based&#xD;
        intervention for youth with PPCS that addresses mental health, while engaging both parents&#xD;
        and youth. It will also elucidate our understanding of how the intervention works, and for&#xD;
        whom. The end product of this research will be a PPCS intervention optimized for&#xD;
        effectiveness and efficiency that will form the basis for a future hybrid implementation&#xD;
        effectiveness trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>Factorial Assignment</intervention_model>
      <intervention_model_description>Youth are randomized into one of 8 pathways which are all combinations of three intervention approaches.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Outcomes are all assessed via self-report so masking of research team is not necessary.&#xD;
  Participants and interventionists cannot be masked as to what intervention the participants receiving.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Health Behavior Inventory (HBI)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>A 20-item questionnaire that assesses concussive symptoms on a 4-point scale, ranging from &quot;never&quot; to &quot;often,&quot; and yields total scores in cognitive and somatic domains. The scale includes youth-report and parent-report versions with established reliability and validity in youth with sports-injury.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>A 23-item questionnaire that assesses physical, emotional, social and school functioning. The scale includes youth-report and parent-report versions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder-7 item (GAD-7)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>A 7-item measure of youth anxiety symptoms during the prior two weeks on a 4-point scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 item (PHQ-9)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>A 9-item questionnaire that measures severity of depressive symptoms. Reliability and validity of the PHQ-9 have been established in pediatric populations with injury.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adolescent Sleep Wake Scale-10 item (ASWS-10)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>A measure of sleep quality including domains of falling asleep, reinitiating sleep and returning to wakefulness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Inventory for Parents (PIP)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>15 item scale measuring parent distress regarding their child's illness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Headache daily diary</measure>
      <time_frame>Trajectory over one year (baseline, 3 months, 6 months, 1 year)</time_frame>
      <description>7 day diary measuring headache occurrence and severity (0-10) daily</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood daily diary</measure>
      <time_frame>Trajectory over one year (baseline, 3 months, 6 months, 1 year)</time_frame>
      <description>7 day diary measuring mood valence (0= very negative to 10= very positive) and energy level (0=very low energy to 10= very high energy level)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Parent-Patient Activation Measure (P-PAM)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>The 10-item P-PAM will be used to assess parenting self-efficacy in advocacy within the health care system (knowledge, skills, and confidence for managing their child's health care).22 The 4-point scale ranges from &quot;disagree strongly&quot; to &quot;agree strongly&quot; (e.g., &quot;I am confident I can tell a doctor concerns I have about my child's health&quot;). (Mediator for CM)</description>
    </other_outcome>
    <other_outcome>
      <measure>Generalized self-efficacy (GSE)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>This 10-item scale measures general self-efficacy on a scale of 1 (not at all true) to 4 (exactly true) on items such as &quot;I can usually handle whatever comes my way,&quot; with higher scores indicating greater self-efficacy23. Youth will provide self-report on this measure.(Mediator for cf-CBT)</description>
    </other_outcome>
    <other_outcome>
      <measure>Adult responses to child's symptoms (ARCS)</measure>
      <time_frame>Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)</time_frame>
      <description>Measure of protective parenting responses to child symptoms (Goal is decreased, Mediator for PST)</description>
    </other_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">374</enrollment>
    <condition>Concussion, Brain</condition>
    <condition>Brain Injury Traumatic Mild</condition>
    <arm_group>
      <arm_group_label>Pathway 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All interventions: cf-CBT, PST &amp; CM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>cf-CBT &amp; PST</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>cf-CBT &amp; CM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PST &amp; CM</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 5</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>cf-CBT only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 6</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PST only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 7</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CM only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pathway 8</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No interventions</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Concussion-focused cognitive behavioral therapy</intervention_name>
      <description>Youth randomized to receive this component will participate in six 30-minute sessions of cf-CBT. The intervention includes modular CBT targeting post-concussive, anxiety and depressive symptoms. In this CBT treatment, the adolescent can be taught coping skills, relaxation strategies, and cognitive strategies to manage their symptoms, while they are encouraged to increase appropriate activation, including pacing of activities. Six sessions from the CHIP Study Cognitive and Behavioral Skills for Concussion Recovery will be chosen by the interventionist based on the youth's goals in the Introduction Session.</description>
      <arm_group_label>Pathway 1</arm_group_label>
      <arm_group_label>Pathway 2</arm_group_label>
      <arm_group_label>Pathway 3</arm_group_label>
      <arm_group_label>Pathway 5</arm_group_label>
      <other_name>cf-CBT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent skills training</intervention_name>
      <description>The focus of the PST component is on the use of positive parenting skills as well as helping parents manage their own emotional distress. Parents are taught to set positive recovery expectations, and to use praise or attention to increase their teen's positive coping behaviors and decrease unhelpful coping behaviors. They are also taught positive communication skills to use with their teen, and guided to schedule pleasant events together in order to strengthen the relationship. In-vivo skills practice and feedback are provided to help parents generalize and use PST techniques. Parents randomized to receive this component will participate in six 30-minute sessions of PST, chosen from the CHIP Study Parent Support Skills Training for Concussion recovery based on the parent's goals in the Introduction Session.</description>
      <arm_group_label>Pathway 1</arm_group_label>
      <arm_group_label>Pathway 2</arm_group_label>
      <arm_group_label>Pathway 4</arm_group_label>
      <arm_group_label>Pathway 6</arm_group_label>
      <other_name>PST</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Care management</intervention_name>
      <description>In the CM component, parents are provided support regarding advocating for their child's needs across different contexts in the healthcare system, school and athletic departments (including guidance regarding medication referrals), using applied problem-solving together with the skills coach to address emergent needs. Adolescents can also be involved in CM, if developmentally appropriate based on their age, independence, and interest. Of note, while the CM component engages youth and parents, treatment effects are hypothesized to result from facilitating access to supportive services including medication referrals at the organizational level. Families randomized to receive this component will participate in six 30-minute sessions of CM, following the guidelines in the CHIP Care Management Manual.</description>
      <arm_group_label>Pathway 1</arm_group_label>
      <arm_group_label>Pathway 3</arm_group_label>
      <arm_group_label>Pathway 4</arm_group_label>
      <arm_group_label>Pathway 7</arm_group_label>
      <other_name>CM</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  11-18 years old&#xD;
  &#xD;
            -  Health care provider diagnosed concussion within 1-6 months ≥ 3 new onset or worsening&#xD;
               post-concussive symptoms (measured with the HBI)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization within&#xD;
               6 months&#xD;
  &#xD;
            -  Spinal cord injury or other severe injury that prevent participation&#xD;
  &#xD;
            -  Do not speak Spanish or English (youth and parent)&#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>Sara P Chrisman, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seattle Children's Research Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Carolyn A McCarty, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seattle Children's Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara P Chrisman, MD MPH</last_name>
      <phone>(206) 987-2028</phone>
      <email>chip@seattlechildrens.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carolyn McCarty, PhD</last_name>
    </overall_contact_backup>
    <link>
      <url>http://chipstudy.org</url>
      <description>Study website</description>
    </link>
    <reference>
      <citation>McCarty CA, Zatzick D, Stein E, Wang J, Hilt R, Rivara FP; Seattle Sports Concussion Research Collaborative. Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20160459. doi: 10.1542/peds.2016-0459. Epub 2016 Sep 13.</citation>
      <PMID>27624513</PMID>
    </reference>
    <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>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Concussion</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06036147
  org study id: 00004199
  secondary id: R01HD090230
  nct id: NCT06036147
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  More than 1 million U.S. youth sustain a concussion each year, and up to 30% report
        persistent post- concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with
        normal adolescent development, resulting in issues with socioemotional dysfunction and even
        school failure. Despite these concerns, few evidence based treatments are available for youth
        with PPCS. We have conducted extensive work adapting a collaborative care framework for youth
        with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills
        training (PST) and care management (CM) to create wraparound treatment for youth with PPCS
        that can be delivered either in- person or virtually. We completed an R01-funded randomized
        controlled trial with this approach, finding effectiveness for youth with PPCS, with
        improvements in concussive symptoms and quality of life at one year, and 60% of participants
        completing the intervention entirely virtually. Of note, this intervention is unique in that
        two of the components are focused on parents or parents and youth together (PST, CM), and
        only one of the components (cf-CBT) is solely youth focused. We now propose to optimize and
        refine this approach, conducting a high efficiency MOST (multiphase optimization strategy)
        trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to
        effectiveness, thereby allowing us to streamline the intervention to only include active
        components. The analysis will be factorial, with three intervention components and two levels
        of each (present or absent), resulting in 8 possible treatment combinations. The benefit of
        the MOST approach is that it combines all youth who receive a component, allowing us to
        assess all treatment components with only a modest sample size. We will recruit 374 youth
        with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend
        treatment sessions via video conferencing software over three months, and complete surveys
        regarding primary outcomes (concussive symptoms and health-related quality of life) and
        secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3/ 6 /12 months.
        We will also assess potential mediators and moderators to allow for future tailoring and
        refinement. At the completion of this study, we will have a completely optimized and refined
        intervention for youth with PPCS ready for large scale implementation and dissemination.
  Concussion is common among adolescents, affecting up to 1.9 million U.S. youth per year.
        Although many youth recover quickly, up to 30% experience difficulty concentrating, headache,
        sleep disruption and other symptoms extending one month or longer, characterized as
        persistent post-concussive symptoms (PPCS). Youth with PPCS can have symptoms for months,
        leading to declines in academic function and quality of life, as well as excessive healthcare
        costs. Research indicates mental health comorbidity is linked to greater likelihood of
        prolonged concussive symptoms, however evidence regarding mental health interventions for
        PPCS is still developing and mental health approaches are not included in the standard of
        care. Our team successfully adapted and tested a mental health intervention for youth with
        PPCS involving collaborative care (CC) delivery of youth concussion-focused
        cognitive-behavioral therapy (cf-CBT), parenting skills training (PST) and care management
        (CM), with medication guidance as needed. We completed an R01 level randomized controlled
        trial of the CC approach for youth with PPCS, finding evidence for long-term gains; those
        receiving CC had improvements at 12 months in concussion symptoms (Cohen's d=0.32) and
        health-related quality of life (HRQoL) (Cohen's d=0.29) compared to usual care. Perhaps most
        importantly, more than half of families (60%) completed the intervention entirely virtually,
        expanding accessibility. While our multicomponent CC approach was effective, research
        suggests duration and complexity of evidence-based mental health interventions affect the
        likelihood of successful implementation and dissemination.
  
        We are now striving to optimize the CC approach by assessing the contribution of each
        component in order to increase efficiency and scalability while maximizing effectiveness. We
        have chosen to view the CC intervention treatment effects using the frame of the
        Socioecological Model,16 postulating that cf-CBT targets the individual level, PST targets
        the interpersonal level (i.e., relationships with parents) and CM targets the organizational
        level (i.e., linkages to medical, school, and other services). We have also worked to amplify
        each component, noting in previous trials that concussive symptoms, sleep and HRQoL improved
        significantly in the intervention group compared to usual care, without a concomitant
        improvement in headache.14 In response, we increased the focus on skills for managing
        headache in the cf-CBT and PST components, with the guidance of a pain psychologist. We also
        increased the rigor and structure of all components with greater oversight regarding delivery
        and duration. Our next step is to assess the separate contribution of each different leveled
        component (cf-CBT, PST and CM) to determine their impact on youth and parent outcomes.
  
        We propose to conduct an optimization trial with the CC approach for youth with PPCS,
        utilizing a highly efficient analytic approach, the multiphase optimization strategy
        (MOST).The design will be factorial, with three components (cf-CBT, PST and CM) each with two
        levels (present or absent). We will recruit adolescents aged 11-18 with PPCS lasting at least
        1 month from outpatient clinics, randomizing families to one of 8 groups to assess all
        combinations of treatment components. Families will participate in sessions virtually and
        complete surveys at 3, 6 and 12 months to measure proximal and distal outcomes. We will
        examine potential mechanisms of action for each component and explore differential
        effectiveness across baseline factors via moderation. We will sample youth from two distinct
        geographic regions to enhance diversity and improve generalizability.
  
        Aim 1. Determine which components of the CC approach (cf-CBT, PST and CM) contribute
        significantly to improvements in distal outcomes, particularly concussive symptoms and youth
        HRQoL, among a diverse sample of youth with PPCS.
  
        1a. Examine the effect of intervention components on proximal outcomes including youth
        headache, mood and sleep, and parental distress regarding their child's illness.
  
        Aim 2. Assess potential mediation of intervention component effects by postulated mechanistic
        factors including improvements in a) youth self-efficacy, b) positive parenting behavior and
        c) parental self-efficacy regarding navigating their child's concussion care.
  
        Aim 3. Explore moderation of intervention component effects by demographic (parental
        education level, youth race/ethnicity, youth sex) and clinical factors (youth depression and
        level of parent emotional distress).
  
        The proposed study will advance concussion research by continuing to refine an evidence-based
        intervention for youth with PPCS that addresses mental health, while engaging both parents
        and youth. It will also elucidate our understanding of how the intervention works, and for
        whom. The end product of this research will be a PPCS intervention optimized for
        effectiveness and efficiency that will form the basis for a future hybrid implementation
        effectiveness trial.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Youth are randomized into one of 8 pathways which are all combinations of three intervention approaches.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Outcomes are all assessed via self-report so masking of research team is not necessary.
  Participants and interventionists cannot be masked as to what intervention the participants receiving.
  measure: Health Behavior Inventory (HBI)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: A 20-item questionnaire that assesses concussive symptoms on a 4-point scale, ranging from "never" to "often," and yields total scores in cognitive and somatic domains. The scale includes youth-report and parent-report versions with established reliability and validity in youth with sports-injury.
  measure: Pediatric Quality of Life Inventory (PedsQL)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: A 23-item questionnaire that assesses physical, emotional, social and school functioning. The scale includes youth-report and parent-report versions.
  measure: Generalized Anxiety Disorder-7 item (GAD-7)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: A 7-item measure of youth anxiety symptoms during the prior two weeks on a 4-point scale.
  measure: Patient Health Questionnaire-9 item (PHQ-9)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: A 9-item questionnaire that measures severity of depressive symptoms. Reliability and validity of the PHQ-9 have been established in pediatric populations with injury.
  measure: Adolescent Sleep Wake Scale-10 item (ASWS-10)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: A measure of sleep quality including domains of falling asleep, reinitiating sleep and returning to wakefulness.
  measure: Pediatric Inventory for Parents (PIP)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: 15 item scale measuring parent distress regarding their child's illness.
  measure: Headache daily diary
  time frame: Trajectory over one year (baseline, 3 months, 6 months, 1 year)
  description: 7 day diary measuring headache occurrence and severity (0-10) daily
  measure: Mood daily diary
  time frame: Trajectory over one year (baseline, 3 months, 6 months, 1 year)
  description: 7 day diary measuring mood valence (0= very negative to 10= very positive) and energy level (0=very low energy to 10= very high energy level)
  measure: Parent-Patient Activation Measure (P-PAM)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: The 10-item P-PAM will be used to assess parenting self-efficacy in advocacy within the health care system (knowledge, skills, and confidence for managing their child's health care).22 The 4-point scale ranges from "disagree strongly" to "agree strongly" (e.g., "I am confident I can tell a doctor concerns I have about my child's health"). (Mediator for CM)
  measure: Generalized self-efficacy (GSE)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: This 10-item scale measures general self-efficacy on a scale of 1 (not at all true) to 4 (exactly true) on items such as "I can usually handle whatever comes my way," with higher scores indicating greater self-efficacy23. Youth will provide self-report on this measure.(Mediator for cf-CBT)
  measure: Adult responses to child's symptoms (ARCS)
  time frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
  description: Measure of protective parenting responses to child symptoms (Goal is decreased, Mediator for PST)
  arm group label: Pathway 1
  arm group type: Experimental
  description: All interventions: cf-CBT, PST & CM
  arm group label: Pathway 2
  arm group type: Experimental
  description: cf-CBT & PST
  arm group label: Pathway 3
  arm group type: Experimental
  description: cf-CBT & CM
  arm group label: Pathway 4
  arm group type: Experimental
  description: PST & CM
  arm group label: Pathway 5
  arm group type: Experimental
  description: cf-CBT only
  arm group label: Pathway 6
  arm group type: Experimental
  description: PST only
  arm group label: Pathway 7
  arm group type: Experimental
  description: CM only
  arm group label: Pathway 8
  arm group type: No Intervention
  description: No interventions
  intervention type: Behavioral
  intervention name: Concussion-focused cognitive behavioral therapy
  description: Youth randomized to receive this component will participate in six 30-minute sessions of cf-CBT. The intervention includes modular CBT targeting post-concussive, anxiety and depressive symptoms. In this CBT treatment, the adolescent can be taught coping skills, relaxation strategies, and cognitive strategies to manage their symptoms, while they are encouraged to increase appropriate activation, including pacing of activities. Six sessions from the CHIP Study Cognitive and Behavioral Skills for Concussion Recovery will be chosen by the interventionist based on the youth's goals in the Introduction Session.
  arm group label: Pathway 1
  arm group label: Pathway 2
  arm group label: Pathway 3
  arm group label: Pathway 5
  other name: cf-CBT
  intervention type: Behavioral
  intervention name: Parent skills training
  description: The focus of the PST component is on the use of positive parenting skills as well as helping parents manage their own emotional distress. Parents are taught to set positive recovery expectations, and to use praise or attention to increase their teen's positive coping behaviors and decrease unhelpful coping behaviors. They are also taught positive communication skills to use with their teen, and guided to schedule pleasant events together in order to strengthen the relationship. In-vivo skills practice and feedback are provided to help parents generalize and use PST techniques. Parents randomized to receive this component will participate in six 30-minute sessions of PST, chosen from the CHIP Study Parent Support Skills Training for Concussion recovery based on the parent's goals in the Introduction Session.
  arm group label: Pathway 1
  arm group label: Pathway 2
  arm group label: Pathway 4
  arm group label: Pathway 6
  other name: PST
  intervention type: Behavioral
  intervention name: Care management
  description: In the CM component, parents are provided support regarding advocating for their child's needs across different contexts in the healthcare system, school and athletic departments (including guidance regarding medication referrals), using applied problem-solving together with the skills coach to address emergent needs. Adolescents can also be involved in CM, if developmentally appropriate based on their age, independence, and interest. Of note, while the CM component engages youth and parents, treatment effects are hypothesized to result from facilitating access to supportive services including medication referrals at the organizational level. Families randomized to receive this component will participate in six 30-minute sessions of CM, following the guidelines in the CHIP Care Management Manual.
  arm group label: Pathway 1
  arm group label: Pathway 3
  arm group label: Pathway 4
  arm group label: Pathway 7
  other name: CM
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Sara P Chrisman, MD MPH
  role: Principal Investigator
  affiliation: Seattle Children's Research Institute
  last name: Carolyn A McCarty, PhD
  role: Principal Investigator
  affiliation: Seattle Children's Research Institute
  last name: Sara P Chrisman, MD MPH
  phone: (206) 987-2028
  email: chip@seattlechildrens.org
  last name: Carolyn McCarty, PhD
  url: http://chipstudy.org
  description: Study website
  citation: McCarty CA, Zatzick D, Stein E, Wang J, Hilt R, Rivara FP; Seattle Sports Concussion Research Collaborative. Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20160459. doi: 10.1542/peds.2016-0459. Epub 2016 Sep 13.
  PMID: 27624513
  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: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Concussion
  mesh term: Brain Injuries, Traumatic
  mesh term: Wounds and Injuries
  sharing ipd: No