Care for Post-Concussive Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Change in Depressive Symptoms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental
Stepped Care
Intervention: Stepped Care (Behavioral)
Control
Usual Care
Outcomes
Primary Outcomes
Change in Depressive Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PHQ-9
Change in Concussion Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
Health Behavior Inventory Assessment
Change in Anxiety Symptoms
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PROMIS A-8
Change in Quality of Life
Time Frame: At enrollment, 1 month, 3 months, and 6 months
PedsQL
Secondary Outcomes
- Change in School Functioning(At enrollment, 1 month, 3 months, and 6 months)
- Change in Parent Depressive Symptoms(At enrollment, 1 month, 3 months, and 6 months)
- Change in Family Functioning(At enrollment, 1 month, 3 months, and 6 months)
- Change in Parent Anxiety Symptoms(At enrollment, 1 month, 3 months, and 6 months)
- Change in ImPACT Assessment(At enrollment and 6 months)
- Change in King-Devick Test(at enrollment and 6 months)
- NIH Toolbox - Dimensional Card Sort Test(At enrollment and 6 months)
- Change in NIH Toolbox - Picture Memory Sequence Test(At enrollment and 6 months)
Investigators
Fred Rivara
Seattle Children's Guild Endowed Chair in Pediatrics
Seattle Children's Hospital