Program to improve health after concussion in youth
Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms
This study is testing a new online program that helps teenagers aged 11-18 who have ongoing symptoms after a concussion feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06036147 on ClinicalTrials.gov |
What this trial studies
This program addresses the needs of youth aged 11-18 who experience persistent post-concussive symptoms (PPCS) after a concussion. It combines concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST), and care management (CM) to create a comprehensive treatment approach that can be delivered remotely. The intervention aims to improve symptoms and quality of life for adolescents suffering from PPCS, with evidence from previous trials indicating its effectiveness. The program is designed to be accessible, with a significant portion of participants completing it entirely online.
Who should consider this trial
Good fit: Ideal candidates are youth aged 11-18 who have been diagnosed with a concussion within the past 1-12 months and are experiencing new or worsening post-concussive symptoms.
Not a fit: Patients with active suicidal ideation, severe psychiatric conditions, or chronic illnesses that impede participation may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and recovery outcomes for youth suffering from persistent symptoms after a concussion.
How similar studies have performed: Previous studies have shown success with similar collaborative care approaches for youth with PPCS, indicating promise for this intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern (UTSW) — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sara P Chrisman, MD MPH — Seattle Children's Hospital
- Study coordinator: Sara P Chrisman, MD MPH
- Email: chip@seattlechildrens.org
- Phone: (206) 987-2028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.