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

NCT04111991 | Completed

• 1 other identifier: STUDY00000529
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Concussion Syndrome

Keywords

Behavior Therapy, Cognitive; Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Change in Brain Connectivity

  Day 0 to Day 35

• Change in Auditory Attention and Working Memory

  Day 0 to Day 35

• Change in Processing Speed

  Day 0 to Day 35

• Change in Phonemic Verbal Fluency

  Day 0 to Day 35

• Change in Cognitive Flexibility

  Day 0 to Day 35

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care in the NCH Complex Concussion Clinic

Behavioral: Usual Care

Usual Care + C-STEP

EXPERIMENTAL

Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

Behavioral: Usual Care; Behavioral: C-STEP (Cognitive Behavioral Therapy)

Interventions

Usual Care BEHAVIORAL

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

Usual Care; Usual Care + C-STEP

C-STEP (Cognitive Behavioral Therapy) BEHAVIORAL

The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training

Usual Care + C-STEP

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sean Rose: lead
• Nationwide Children's Hospital: collaborator
• Ohio State University: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sean Rose, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: January 2, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)