Concussion Health Improvement Program for Youth

This study is testing a Concussion Health Improvement Program for young people aged 11 to 18 who have been diagnosed with a concussion within the last 1 to 12 months and are still experiencing at least three new or worsening symptoms. The program combines three approaches: concussion-focused cognitive behavioral therapy (cf-CBT) to help with symptoms like anxiety and depression, parent skills training (PST) to teach positive parenting techniques, and care management (CM) to support parents in advocating for their child's needs. The goal is to see if these interventions improve concussion symptoms and overall quality of life over one year. This study is conducted remotely, so you can participate from anywhere.

Study design
This is an interventional study planning to enroll 304 participants. It is a randomized controlled trial, meaning participants will be assigned to different treatment groups by chance.
What's involved
Participants will receive six 30-minute sessions of cf-CBT. Parents will also receive parent skills training and care management support.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored over one year, with assessments at baseline, 6 weeks, 3 months, 6 months, and 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06036147

Concussion Health Improvement Program

Recruiting
NAAges 11–18InterventionalTreatment
Seattle Children's Hospital
~304 participants
Updated 2025-03-13 on ClinicalTrials.gov
What's tested:Concussion-focused cognitive behavioral therapyParent skills trainingCare management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Health Behavior Inventory (HBI)
Measured over Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
+1 more outcome measured
Concussion, Brain
Brain Injury Traumatic Mild
1 sites across 1 states
Texas1
  • Sara P Chrisman, MD MPH · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital
  • Carolyn A McCarty, PhD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

11-18 years old
Health care provider diagnosed concussion within 1-12 months
Can be located anywhere as study is all completed remotely

Exclusion

Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization within 6 months
Spinal cord injury or other severe injury or illness that might impede participation
Youth or parent not fluent in Spanish or English
Chronic illness or medical conditions that prevent participation in concussion-focused treatment
  • Health Behavior Inventory (HBI)Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)

    A 20-item questionnaire that assesses concussive symptoms on a 4-point scale, ranging from "never" to "often," and yields total scores in cognitive and somatic domains. The scale includes youth-report and parent-report versions with established reliability and validity in youth with sports-injury. Possible scores range from 0-60 with higher indicating more symptomatic (i.e., worse).

  • Pediatric Quality of Life Inventory (PedsQL)Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)

    A 23-item questionnaire that assesses physical, emotional, social and school functioning. The scale includes youth-report and parent-report versions. Possible scores range from 0- 100 with 100 indicating higher quality of life (i.e., better).