Post-Concussion SyndromeNCT04111991
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
A study testing C-STEP (Cognitive Behavioral Therapy) in people with Post-Concussion Syndrome, run by Sean Rose at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- C-STEP (Cognitive Behavioral Therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
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.
Read the 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 Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).
C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Usual Care, C-STEP (Cognitive Behavioral Therapy)
- Keywords
- Behavior Therapy, Cognitive, Post-Concussion Syndrome
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Usual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need
C-STEP (Cognitive Behavioral Therapy)Behavioural
The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care in the NCH Complex Concussion Clinic Receives: Behavioral: Usual Care |
| Usual Care + C-STEP | Experimental | Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP Receives: Behavioral: Usual Care; Behavioral: C-STEP (Cognitive Behavioral Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
This is a 22-item self and parent-reported list of common concussion symptoms filled out on a 0-6 Likert scale. Scores range from 0 to 122. Higher scores are indicative of worse concussion symptoms.
Measured: Day 0 to Day 35
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
This is a 23-item self and parent-reported quality of life metric. Each item is rated on a scale of 0-4. Scores range from 0-100 for each subscale (Physical Functioning; Emotional Functioning; Social Functioning; School Functioning) and for the total score. Higher scores are indicative of better quality of life.
Measured: Day 0 to Day 35
Secondary outcomes (7)
Change in Brain Connectivity
An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.
Measured: Day 0 to Day 35
Change in Auditory Attention and Working Memory
The digit span forwards and backwards subtest from Wechsler Individual Scales of Intelligence, fifth edition (WISC-V) (age 12-16) or Wechsler Adult Intelligence Scales, fourth edition (WAIS-IV) (age 17-18) will test auditory attention and working memory. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for process scores of Digits Forward and Digits backward.
Measured: Day 0 to Day 35
Change in Processing Speed
The processing speed index, which consists of the Coding and Symbol Search subtests from the from WISC-V (age 12-16) or WAIS-IV (age 17-18) will test processing speed. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for Coding and Symbol Search subtests. Scaled scores for these will be summed and used to calculate the Processing Speed Index standard score (range 45-155, higher is better performance).
Measured: Day 0 to Day 35
Change in Phonemic Verbal Fluency
The Phonemic Verbal Fluency (letter fluency) subtest from the Delis Kaplan Executive Function Scales (DKEFS) will test executive functioning and phonemic verbal fluency. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for the phonemic fluency subtest.
Measured: Day 0 to Day 35
Change in Cognitive Flexibility
The Letter Number Sequencing subtest from from DKEFS will test cognitive flexiblity. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for the number sequencing and letter-number sequencing trials.
Measured: Day 0 to Day 35
Change in Verbal Memory
The Lists (immediate, delayed, and recognition) subtest from the Child and Adolescent Memory Profile (ChAMP) tests verbal memory. Age-normed scaled scores (range 1-19, higher is better performance) will be calculated for Lists, Lists Delayed, and Lists recognition subtests.
Measured: Day 0 to Day 35
Change in Performance Validity
The Medical Symptom Validity Test- (MSVT) will test effort/performance validity. Percentage scores for immediate recognition, delayed recognition, consistency, paired associates, and free recalls will be calculated. Performance will be classified as Pass vs. Fail.
Measured: Day 0 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start2 Jan 2020
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sean Rose
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Ohio State University
- Responsible party
- Sponsor-investigator, Sean Rose, Nationwide Children's Hospital
- Investigators
- Sean Rose, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111991
- Sponsor's protocol ID
- STUDY00000529
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2019
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
- ClinicalTrials.gov ID
- NCT04111991
- Acronym / sponsor ID
- STUDY00000529
- Conditions
- Post-Concussion Syndrome
- Keywords
- Behavior Therapy, Cognitive, Post-Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sean RoseUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Ohio State University
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).
C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareUsual care in the NCH Complex Concussion Clinic |
| Usual Care + C-STEP | Experimental | Behavioral: Usual Care, Behavioral: C-STEP (Cognitive Behavioral Therapy)Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareUsual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need | Behavioural | Usual Care, Usual Care + C-STEP |
| C-STEP (Cognitive Behavioral Therapy)The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training | Behavioural | Usual Care + C-STEP |
Primary outcome
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
Time frame: Day 0 to Day 35
This is a 22-item self and parent-reported list of common concussion symptoms filled out on a 0-6 Likert scale. Scores range from 0 to 122. Higher scores are indicative of worse concussion symptoms.
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
Time frame: Day 0 to Day 35
This is a 23-item self and parent-reported quality of life metric. Each item is rated on a scale of 0-4. Scores range from 0-100 for each subscale (Physical Functioning; Emotional Functioning; Social Functioning; School Functioning) and for the total score. Higher scores are indicative of better quality of life.
7 secondary outcomes
Change in Brain Connectivity
Time frame: Day 0 to Day 35
Change in Auditory Attention and Working Memory
Time frame: Day 0 to Day 35
Change in Processing Speed
Time frame: Day 0 to Day 35
Change in Phonemic Verbal Fluency
Time frame: Day 0 to Day 35
Change in Cognitive Flexibility
Time frame: Day 0 to Day 35
Change in Verbal Memory
Time frame: Day 0 to Day 35
Change in Performance Validity
Time frame: Day 0 to Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Rose, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-STEP (Cognitive Behavioral Therapy) in people with Post-Concussion Syndrome, run by Sean Rose at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms (time frame: Day 0 to Day 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.