Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome (NCT04111991) | Clinical Trial Compass
CompletedNot Applicable
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
United States37 participantsStarted 2020-01-02
Plain-language 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-concussion syndrome.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 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 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
Timeframe: Day 0 to Day 35
2
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)