NCT02268240

Care for Post-Concussive Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Concussion

Interventions

Type	Name	Description
BEHAVIORAL	Stepped Care	Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-20
• Last updated: 2018-09-18

Locations

1 site across 1 country: United States