Clinical trial NCT02268240: Care for Post-Concussive Symptoms
Official title: Care for Post-Concussive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2014-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Concussion Symptoms
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Depressive Symptoms
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Anxiety Symptoms
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Quality of Life
timeFrame: At enrollment, 1 month, 3 months, and 6 months
Secondary outcomes:
measure: Change in School Functioning
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Family Functioning
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Parent Anxiety Symptoms
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in Parent Depressive Symptoms
timeFrame: At enrollment, 1 month, 3 months, and 6 months
measure: Change in ImPACT Assessment
timeFrame: At enrollment and 6 months
measure: NIH Toolbox - Dimensional Card Sort Test
timeFrame: At enrollment and 6 months
measure: Change in NIH Toolbox - Picture Memory Sequence Test
timeFrame: At enrollment and 6 months
measure: Change in King-Devick Test
timeFrame: at enrollment and 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Childrens Hospital
state: Washington
Study officials:
affiliation: Seattle Childrens Hospital
name: Frederick P Rivara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.