Status:
COMPLETED
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
Lead Sponsor:
Sean Rose
Collaborating Sponsors:
Nationwide Children's Hospital
Ohio State University
Conditions:
Post-Concussion Syndrome
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
This prospective randomized intervention study aims to determine if the Concussion Symptom Treatment Program (C-STEP), a cognitive behavioral therapy, improves outcomes for children with post-concussi...
Detailed Description
This prospective randomized intervention study aims to determine if C-STEP improves outcomes for children with post-concussion syndrome. Forty children with post-concussion syndrome referred to the Na...
Eligibility Criteria
Inclusion
- Children age 10-17 years or adults age 18 years (total age range 10-18) at the time of the enrollment visit
- Diagnosed concussion occurring between 1 month and 12 months prior to the enrollment visit
- Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
- Intent to participate in the full CCC treatment program (including exercise visits once per week)
Exclusion
- Adults unable to consent, Prisoners, Females currently known to be pregnant, Non-English speaking patient
- Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)
- Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)
- Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)
Key Trial Info
Start Date :
January 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04111991
Start Date
January 2 2020
End Date
November 30 2024
Last Update
May 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205