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

NCT04111991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-05-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Sean Rose

    lead OTHER

Principal Investigators

  • Sean Rose, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111991 on ClinicalTrials.gov