Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth

Completed · Not applicable

Conditions studied: Concussion, Brain, TBI, Depression, Anxiety

In brief

SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents. In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.

Key facts

Study ID

NCT03034720

Run by

Seattle Children's Hospital

People needed

200

Starts

2017-03-09

Expected to finish

2020-05-29

Last updated by the study team

2021-04-08

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English speaking male and female sports-injured adolescents
• ages 11-18
• health care provider diagnosed concussion and with ≥ 3 HBI symptoms that have endured or worsened for at least 1-month but less than 9 months since injury will be included in the investigation.

You may not qualify if…

• Adolescents who require immediate intervention (e.g., acute suicidal ideation) will be excluded.
• Adolescents whose parents report that their child has ever had a diagnosis of schizophrenia or psychosis will be excluded from the study.
• Adolescents whose parents report concerns about their child's ability to communicate may be excluded from the study (pending consult with PIs).
• Adolescents who have suffered spinal cord or other severe injuries that prevent participation will be excluded from the study.
• Adults unable to consent are not included in this research
• Adolescents and parents who do not read and speak English will not be included
• Wards of the state are not included in this research
• Pregnant women are not included in this research
• Prisoners are not included in this research

Where it is running

• Seattle Childrens Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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