Depression Clinical Trial
Official title:
Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
Verified date | April 2021 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 29, 2020 |
Est. primary completion date | May 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Childrens Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital |
United States,
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 Mar 18:1-13. doi: 10.1080/02699052.2021.1889663. [Epub ahead of print] — View 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 Postconcussive Symptoms. J Pediatr Psychol. 2021 Jan 7. pii: jsaa128. doi: 10.1093/jpepsy/jsaa128. [Epub ahead of print] — View 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. — View 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):e21020 — View Citation
Payne KM, Prentice ET, Marcynyszyn LA, McCarty CA. Goals for Persistent Postconcussive Symptom Treatment From Adolescent and Parent Perspectives. JAMA Pediatr. 2020 May 11. doi: 10.1001/jamapediatrics.2020.0898. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Outcome Measure | 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. | During the 12 months after enrollment | |
Primary | 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. | |
Primary | 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 | |
Primary | 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. | |
Primary | 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 | |
Primary | 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 | School performance as measured by GPA | During the 12 months after enrollment | ||
Secondary | Return to full activities at school as measured by the CLASS | 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 | During the 12 months after enrollment |
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