Expired Study
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Seattle, Washington 98105


Purpose:

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.


Criteria:

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


NCT ID:

NCT02268240


Primary Contact:

Principal Investigator
Frederick P Rivara, MD, MPH
Seattle Childrens Hospital


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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