Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-Concussion Syndrome
- Sponsor
- Sean Rose
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Sean Rose
Assistant Professor of Pediatrics
Nationwide Children's Hospital
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)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in Brain Connectivity(Day 0 to Day 35)
- Change in Auditory Attention and Working Memory(Day 0 to Day 35)
- Change in Phonemic Verbal Fluency(Day 0 to Day 35)
- Change in Performance Validity(Day 0 to Day 35)
- Change in Processing Speed(Day 0 to Day 35)
- Change in Cognitive Flexibility(Day 0 to Day 35)
- Change in Verbal Memory(Day 0 to Day 35)