Care for Post-Concussive Symptoms (CARE4PCS)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
49 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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