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Study identifier: NCT06036147 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Concussion Health Improvement Program

Condition: Concussion, Brain · Brain Injury Traumatic Mild  ·  Sponsor: Seattle Children's Hospital

PhaseNA
Planned participants304
Who can joinAll sexes, 11 Years to 18 Years
Healthy volunteersNo

About this study

More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be f…

This description comes directly from the study's public registry record.

Talk to the study team

Sara P Chrisman, MD MPH  ·  (206) 987-2028  ·  chip@seattlechildrens.org

Carolyn McCarty, PhD

Always discuss trial participation with your own doctor first.

Locations (1)

University of Texas Southwestern (UTSW)Dallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06036147