Care for Post-Concussive Symptoms
- Conditions
- Concussion
- Interventions
- Behavioral: Stepped Care
- Registration Number
- NCT02268240
- Lead Sponsor
- Seattle Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
- Active suicidality
- Substance dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Stepped Care Stepped Care
- Primary Outcome Measures
Name Time Method Change in Depressive Symptoms At enrollment, 1 month, 3 months, and 6 months PHQ-9
Change in Concussion Symptoms At enrollment, 1 month, 3 months, and 6 months Health Behavior Inventory Assessment
Change in Anxiety Symptoms At enrollment, 1 month, 3 months, and 6 months PROMIS A-8
Change in Quality of Life At enrollment, 1 month, 3 months, and 6 months PedsQL
- Secondary Outcome Measures
Name Time Method Change in School Functioning At enrollment, 1 month, 3 months, and 6 months Attendance and Grades
Change in Parent Depressive Symptoms At enrollment, 1 month, 3 months, and 6 months PHQ-9
Change in Family Functioning At enrollment, 1 month, 3 months, and 6 months FAD-GF
Change in Parent Anxiety Symptoms At enrollment, 1 month, 3 months, and 6 months PROMIS A-8
Change in ImPACT Assessment At enrollment and 6 months ImPACT test scores
Change in King-Devick Test at enrollment and 6 months King-Devick Test scores
NIH Toolbox - Dimensional Card Sort Test At enrollment and 6 months Dimensional Card Sort Test scores
Change in NIH Toolbox - Picture Memory Sequence Test At enrollment and 6 months Picture Memory Sequence test scores
Trial Locations
- Locations (1)
Seattle Childrens Hospital
🇺🇸Seattle, Washington, United States