Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
Primary Purpose
Post-Concussion Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
C-STEP (Cognitive Behavioral Therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Behavior Therapy, Cognitive, Post-Concussion Syndrome
Eligibility Criteria
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)
Sites / Locations
- Nationwide Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
Usual Care + C-STEP
Arm Description
Usual care in the NCH Complex Concussion Clinic
Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in Brain Connectivity
An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.
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.
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).
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.
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.
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.
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.
Full Information
NCT ID
NCT04111991
First Posted
September 30, 2019
Last Updated
September 20, 2022
Sponsor
Sean Rose
Collaborators
Nationwide Children's Hospital, Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT04111991
Brief Title
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
Official Title
Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sean Rose
Collaborators
Nationwide Children's Hospital, Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome
Keywords
Behavior Therapy, Cognitive, Post-Concussion Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care in the NCH Complex Concussion Clinic
Arm Title
Usual Care + C-STEP
Arm Type
Experimental
Arm Description
Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
C-STEP (Cognitive Behavioral Therapy)
Intervention Description
The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training
Primary Outcome Measure Information:
Title
Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms
Description
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.
Time Frame
Day 0 to Day 35
Title
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
Description
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.
Time Frame
Day 0 to Day 35
Secondary Outcome Measure Information:
Title
Change in Brain Connectivity
Description
An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.
Time Frame
Day 0 to Day 35
Title
Change in Auditory Attention and Working Memory
Description
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.
Time Frame
Day 0 to Day 35
Title
Change in Processing Speed
Description
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).
Time Frame
Day 0 to Day 35
Title
Change in Phonemic Verbal Fluency
Description
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.
Time Frame
Day 0 to Day 35
Title
Change in Cognitive Flexibility
Description
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.
Time Frame
Day 0 to Day 35
Title
Change in Verbal Memory
Description
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.
Time Frame
Day 0 to Day 35
Title
Change in Performance Validity
Description
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.
Time Frame
Day 0 to Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Rose, MD
Phone
6147224625
Email
Sean.Rose@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Rose, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Busch
Phone
614-722-2000
12. IPD Sharing Statement
Learn more about this trial
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome
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