Concussion Health Improvement Program (CHIP): study protocol for a randomized controlled optimization trial for youth with persistent post-concussive symptoms.

BACKGROUND

Up to 1.9 million youth in the USA sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can substantially interfere with social, emotional, and academic functioning. Despite these concerns, few evidence-based treatments are available for youth with PPCS. We previously found effectiveness in treating youth with concussion using a collaborative care intervention that integrates mental health care into a medical model, with improvements in concussive symptoms and quality of life at 1 year. Using the multiphase optimization strategy (MOST) framework, we now aim to assess the contribution of each of the three components that were part of collaborative care: concussion-focused cognitive behavioral therapy (cf-CBT), parenting skills training (PST), and care management (CM).

METHODS

The MOST factorial design examines all three intervention components with two levels of each (present or absent), resulting in 8 possible treatment combinations. We will recruit 368 youth with PPCS from 2 geographic locations (Seattle and Dallas), randomizing them to 1 of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over 3 months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood, and parental distress) at 6 weeks and 3, 6, and 12 months. We will also assess potential mediators and moderators to allow for future tailoring and refinement.

DISCUSSION

The overarching goal of this investigation is to determine which collaborative care components (delivered individually or in combination) are most effective in treating PPCS in concussion-exposed youth. The investigation will inform mental health screening, intervention, and referral procedures for youth and families following concussion. At the completion of this study, we will have an optimized and refined intervention for youth with PPCS ready for large-scale implementation and dissemination.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06036147. Registered on September 13, 2023.