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Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111991
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
Nationwide Children's Hospital Foundation
Chronic Brain Injury Discovery Theme - The Ohio State University
Information provided by (Responsible Party):
Sean Rose, Nationwide Children's Hospital

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-concussion syndrome.

Condition or disease Intervention/treatment Phase
Post-Concussion Syndrome Behavioral: Usual Care Behavioral: C-STEP (Cognitive Behavioral Therapy) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Arm Intervention/treatment
Active Comparator: Usual Care
Usual care in the NCH Complex Concussion Clinic
Behavioral: Usual Care
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

Experimental: Usual Care + C-STEP
Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP
Behavioral: Usual Care
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

Behavioral: C-STEP (Cognitive Behavioral Therapy)
The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in Brain Connectivity [ Time Frame: Day 0 to Day 35 ]
    An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.

  2. Change in Auditory Attention and Working Memory [ Time Frame: Day 0 to Day 35 ]
    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.

  3. Change in Processing Speed [ Time Frame: Day 0 to Day 35 ]
    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).

  4. Change in Phonemic Verbal Fluency [ Time Frame: Day 0 to Day 35 ]
    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.

  5. Change in Cognitive Flexibility [ Time Frame: Day 0 to Day 35 ]
    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.

  6. Change in Verbal Memory [ Time Frame: Day 0 to Day 35 ]
    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.

  7. Change in Performance Validity [ Time Frame: Day 0 to Day 35 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children age 12-17 years or adults age 18 years (total age range 12-18) at the time of the enrollment visit
  • Diagnosed concussion occurring between 1 month and 6 months prior to the enrollment visit
  • Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
  • Participated in the "Predicting outcomes from multi-disciplinary care for post-concussion syndrome" study
  • 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)
  • Primary residence more than 60 miles from the NCH Westerville Sports Medicine building
  • Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111991


Contacts
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Contact: Sean Rose, MD 6147224625 Sean.Rose@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Tyler Busch    614-722-2000      
Sponsors and Collaborators
Sean Rose
Nationwide Children's Hospital Foundation
Chronic Brain Injury Discovery Theme - The Ohio State University
Investigators
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Principal Investigator: Sean Rose, MD Nationwide Children's Hospital
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Responsible Party: Sean Rose, Assistant Professor of Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT04111991    
Other Study ID Numbers: STUDY00000529
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Rose, Nationwide Children's Hospital:
Behavior Therapy, Cognitive
Post-Concussion Syndrome
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Syndrome
Disease
Pathologic Processes
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating