Last updated: February 16, 2024
Sponsor: Sean Rose
Overall Status: Active - Recruiting
Phase
N/A
Condition
Brain Injury
Treatment
Usual Care
C-STEP (Cognitive Behavioral Therapy)
Clinical Study ID
NCT04111991
STUDY00000529
Ages 10-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Children age 10-17 years or adults age 18 years (total age range 10-18) at the time ofthe enrollment visit
- Diagnosed concussion occurring between 1 month and 12 months prior to the enrollmentvisit
- Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
- Intent to participate in the full CCC treatment program (including exercise visitsonce per week)
Exclusion
Exclusion Criteria:
- 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 cognitiveor other disability)
- Anticipated inability to complete a brain MRI (due to claustrophobia, implantedhardware or other contraindications)
- Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization,suicide attempt, history of psychotic symptoms, or bipolar disorder)
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 02, 2020
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesActive - Recruiting
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