Status:
RECRUITING
Concussion Health Improvement Program
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Conditions:
Concussion, Brain
Brain Injury Traumatic Mild
Eligibility:
All Genders
11-18 years
Phase:
NA
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 develo...
Detailed Description
Concussion is common among adolescents, affecting up to 1.9 million U.S. youth per year. Although many youth recover quickly, up to 30% experience difficulty concentrating, headache, sleep disruption ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06036147
Start Date
November 10 2023
End Date
January 31 2028
Last Update
March 13 2025
Active Locations (1)
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1
University of Texas Southwestern (UTSW)
Dallas, Texas, United States, 75390