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

Post-Concussion Syndrome Clinical Trial

Official title:

Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111991
• Other study ID #: STUDY00000529
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Sean Rose, MD
• Phone: 6147224625
• Email: Sean.Rose[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post-Concussion Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Sean Rose	Nationwide Children's Hospital, Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 to Day 35
Primary	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.	Day 0 to Day 35
Secondary	Change in Brain Connectivity	An advanced neuroimaging protocol will measure brain tissue volume, microstructure, and function.	Day 0 to Day 35
Secondary	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.	Day 0 to Day 35
Secondary	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).	Day 0 to Day 35
Secondary	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.	Day 0 to Day 35
Secondary	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.	Day 0 to Day 35
Secondary	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.	Day 0 to Day 35
Secondary	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.	Day 0 to Day 35