Care for Post-Concussive Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Care for Post-Concussive Symptoms

Conditions
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Concussion

Intervention / Treatment
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* Behavioral: Stepped Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages 11 and 18 Have sustained a head impact during sports participation Have incurred an onset or increase of at least three post-concussive symptoms following head impact Have increased post-concussive symptoms following head impact have continued for at least 4 weeks Live with their parents or legal guardians Live within commuting distance of Seattle Children's Hospital Willing to participate in assessment and treatment Have at least one parent/caregiver willing to participate in assessment and treatment Exclusion Criteria: Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder Active suicidality Substance dependence

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Stepped Care | Behavioral: Stepped Care<br>* 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.<br>|
| No Intervention: Control<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |