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Behavioural Intervention
Cognitive Behavioral Therapy + Parent Skills Training for Concussions (CHIP Trial)
N/A
Recruiting
Led By Sara P Chrisman, MD MPH
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
11-18 years old
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to improve the treatment for youth who have persistent post-concussive symptoms (PPCS) after sustaining a concussion. Currently, there are limited evidence-based treatments available for these youth.
Who is the study for?
This trial is for young people aged 11-18 who've been diagnosed with a concussion by a healthcare provider within the past 1-6 months and are experiencing at least three new or worsening symptoms after their injury.
What is being tested?
The study tests a treatment combining cognitive therapy, parent skills training, and care management to help youths recover from post-concussive symptoms. Participants will be randomly assigned to one of eight groups to determine which parts of the treatment are most effective.
What are the potential side effects?
Since this trial involves non-medical interventions like therapy and skills training, traditional side effects associated with medications are not expected. However, participants may experience emotional discomfort during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 11 and 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Health Behavior Inventory (HBI)
Pediatric Quality of Life Inventory (PedsQL)
Secondary study objectives
Adolescent Sleep Wake Scale-10 item (ASWS-10)
Generalized Anxiety Disorder-7 item (GAD-7)
Headache daily diary
+3 moreOther study objectives
Adult responses to child's symptoms (ARCS)
Generalized self-efficacy (GSE)
Parent-Patient Activation Measure (P-PAM)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Pathway 7Experimental Treatment1 Intervention
CM only
Group II: Pathway 6Experimental Treatment1 Intervention
PST only
Group III: Pathway 5Experimental Treatment1 Intervention
PST \& CM
Group IV: Pathway 4Experimental Treatment2 Interventions
cf-CBT only
Group V: Pathway 3Experimental Treatment2 Interventions
cf-CBT \& CM
Group VI: Pathway 2Experimental Treatment2 Interventions
cf-CBT \& PST
Group VII: Pathway 1Experimental Treatment3 Interventions
All interventions: cf-CBT, PST \& CM
Group VIII: Pathway 8Active Control1 Intervention
No interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parent skills training
2019
N/A
~200
Care management
2012
N/A
~30
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,206 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,080 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,089 Previous Clinical Trials
1,059,309 Total Patients Enrolled
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,195 Total Patients Enrolled
Sara P Chrisman, MD MPHPrincipal InvestigatorSeattle Children's Research Institute
2 Previous Clinical Trials
230 Total Patients Enrolled
Carolyn A McCarty, PhDPrincipal InvestigatorSeattle Children's Research Institute