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| Name | Class |
|---|---|
| University of Washington | OTHER |
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The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Stepped Care |
|
| Control | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care | Behavioral | Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Concussion Symptoms | Health Behavior Inventory Assessment | At enrollment, 1 month, 3 months, and 6 months |
| Change in Depressive Symptoms | PHQ-9 | At enrollment, 1 month, 3 months, and 6 months |
| Change in Anxiety Symptoms | PROMIS A-8 | At enrollment, 1 month, 3 months, and 6 months |
| Change in Quality of Life | PedsQL | At enrollment, 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in School Functioning | Attendance and Grades | At enrollment, 1 month, 3 months, and 6 months |
| Change in Family Functioning | FAD-GF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick P Rivara, MD, MPH | Seattle Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Childrens Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27624513 | Derived | 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. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| At enrollment, 1 month, 3 months, and 6 months |
| Change in Parent Anxiety Symptoms | PROMIS A-8 | At enrollment, 1 month, 3 months, and 6 months |
| Change in Parent Depressive Symptoms | PHQ-9 | At enrollment, 1 month, 3 months, and 6 months |
| Change in ImPACT Assessment | ImPACT test scores | At enrollment and 6 months |
| NIH Toolbox - Dimensional Card Sort Test | Dimensional Card Sort Test scores | At enrollment and 6 months |
| Change in NIH Toolbox - Picture Memory Sequence Test | Picture Memory Sequence test scores | At enrollment and 6 months |
| Change in King-Devick Test | King-Devick Test scores | at enrollment and 6 months |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |