| NCT ID | NCT06036147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Children's Hospital |
| Condition | Concussion, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 304 participants in total. It began in 2023-11-10 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three 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. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.
Eligibility Criteria
Inclusion Criteria: * 11-18 years old * Health care provider diagnosed concussion within 1-12 months ≥ 3 new onset or worsening post-concussive symptoms (measured with the HBI) * Can be located anywhere as study is all completed remotely Exclusion Criteria: * Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization within 6 months * Spinal cord injury or other severe injury or illness that might impede participation * Youth or parent not fluent in Spanish or English * Chronic illness or medical conditions that prevent participation in concussion-focused treatment
Contact & Investigator
Sara P Chrisman, MD MPH
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT06036147 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Concussion, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06036147 currently recruiting?
Yes, NCT06036147 is actively recruiting participants. Contact the research team at chip@seattlechildrens.org for enrollment information.
Where is the NCT06036147 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06036147 clinical trial?
NCT06036147 is sponsored by Seattle Children's Hospital. The principal investigator is Sara P Chrisman, MD MPH at Seattle Children's Hospital. The trial plans to enroll 304 participants.