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Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth

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ClinicalTrials.gov Identifier: NCT03034720
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Fred Rivara, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE January 11, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE March 9, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Post-concussive symptoms measured with the HBI [ Time Frame: During the12 months after enrollment. ]
    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.
  • Health related quality of life as measured with the PedsQL [ Time Frame: During the 12 months after enrollment ]
    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.
  • Depressive symptoms measured by the PHQ-9 [ Time Frame: During the12 months after enrollment. ]
    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.
  • Anxiety symptoms measured by the GAD-7 [ Time Frame: During the 12 months after enrollment ]
    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.
  • Anxiety symptoms measured by the RCADS [ Time Frame: During the 12 months after enrollment ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Post-concussive symptoms measured with the HBI [ Time Frame: During the12 months after enrollment. ]
    Our 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.
  • Health related quality of life as measured with the PedsQL [ Time Frame: During the 12 months after enrollment ]
    Our 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.
  • Depressive symptoms measured by the PHQ-9 [ Time Frame: During the12 months after enrollment. ]
    Our 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.
  • Anxiety symptoms measured by the GAD-7 [ Time Frame: During the 12 months after enrollment ]
    Our 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.
  • Anxiety symptoms measured by the RCADS [ Time Frame: During the 12 months after enrollment ]
    Our 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.
Change History Complete list of historical versions of study NCT03034720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • School performance as measured by GPA [ Time Frame: During the 12 months after enrollment ]
  • Return to full activities at school as measured by the CLASS [ Time Frame: During the 12 months after enrollment ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • School performance as measured by GPA [ Time Frame: During the 12 months after enrollment ]
  • Return to full activities at school as measured by the CLASS [ Time Frame: During the 12 months after enrollment ]
    Our 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
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2018)
Exploratory Outcome Measure [ Time Frame: During the 12 months after enrollment ]
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
Official Title  ICMJE Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Concussion, Brain
  • TBI
  • Depression
  • Anxiety
Intervention  ICMJE Behavioral: Collaborative Care
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.
Study Arms  ICMJE
  • Experimental: Intervention
    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.
    Intervention: Behavioral: Collaborative Care
  • No Intervention: Control
    Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking male and female sports-injured adolescents
  • ages 11-18
  • health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured or worsened for at least 1-month but less than 9 months since injury will be included in the investigation.

Exclusion Criteria:

  • Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be excluded.
  • Adolescents whose parents report that their child has ever had a diagnosis of schizophrenia or psychosis will be excluded from the study.
  • Adolescents whose parents report concerns about their child's ability to communicate may be excluded from the study (pending consult with PIs).
  • Adolescents who have suffered spinal cord or other severe injuries that prevent participation will be excluded from the study.

    • Adults unable to consent are not included in this research
    • Adolescents and parents who do not read and speak English will not be included
    • Wards of the state are not included in this research
    • Pregnant women are not included in this research
    • Prisoners are not included in this research
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frederick P Rivara, MD 206-884-1587 FPR@UW.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034720
Other Study ID Numbers  ICMJE STUDY00000437
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Rivara, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederick P Rivara, MD Seattle Children's Research Institute
PRS Account Seattle Children's Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP