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

NCT03034720 | Completed DMC

• 1 other identifier: STUDY00000437
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; TBI; Depression; Anxiety

Keywords

Concussion; persistent post-concussive symptoms; CBT; collaborative care; Depression; Anxiety

Outcome Measures

Primary Outcomes (5)

• Post-concussive symptoms measured with the HBI

  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.

  During the12 months after enrollment.

• Health related quality of life as measured with the PedsQL

  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.

  During the 12 months after enrollment

• Depressive symptoms measured by the PHQ-9

  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.

  During the12 months after enrollment.

• Anxiety symptoms measured by the GAD-7

  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.

  During the 12 months after enrollment

• Anxiety symptoms measured by the RCADS

  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.

  During the 12 months after enrollment

Secondary Outcomes (2)

• School performance as measured by GPA

  During the 12 months after enrollment

• Return to full activities at school as measured by the CLASS

  During the 12 months after enrollment

Other Outcomes (1)

• Exploratory Outcome Measure

  During the 12 months after enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Collaborative Care

Control

NO INTERVENTION

Adolescent subjects in the control group will receive care as usual from their health care providers, a standard that is ethically acceptable.

Interventions

Collaborative Care BEHAVIORAL

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

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• Marcynyszyn LA, McCarty CA, Chrisman SPD, Zatzick DF, Johnson AM, Wang J, Hilt RJ, Rivara FP. Psychometric Properties and Validation of the General Anxiety Disorder 7-Item Scale Among Adolescents With Persistent Post-Concussive Symptoms. Neurotrauma Rep. 2023 Apr 27;4(1):276-283. doi: 10.1089/neur.2022.0075. eCollection 2023.

  PMID: 37139182 DERIVED

MeSH Terms

Conditions

Brain Concussion; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Frederick P Rivara, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 27, 2017
• Study Start: March 9, 2017
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)