NCT06036147 · Seattle Children's Hospital
Concussion Health Improvement Program
(CHIP)
What this study is about
More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS.
View original scientific description
More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.
Interventions
BEHAVIORAL
Concussion-focused cognitive behavioral therapy
Youth randomized to receive this component will participate in six 30-minute sessions of cf-CBT. The intervention includes modular CBT targeting post-concussive, anxiety and depressive symptoms. In this CBT treatment, the adolescent can be taught coping skills, relaxation strategies, and cognitive strategies to manage their symptoms, while they are encouraged to increase appropriate activation, including pacing of activities. Six sessions from the CHIP Study Cognitive and Behavioral Skills for Concussion Recovery will be chosen by the interventionist based on the youth's goals in the Introduction Session.
BEHAVIORAL
Parent skills training
The focus of the PST component is on the use of positive parenting skills as well as helping parents manage their own emotional distress. Parents are taught to set positive recovery expectations, and to use praise or attention to increase their teen's positive coping behaviors and decrease unhelpful coping behaviors. They are also taught positive communication skills to use with their teen, and guided to schedule pleasant events together in order to strengthen the relationship. In-vivo skills practice and feedback are provided to help parents generalize and use PST techniques. Parents randomized to receive this component will participate in six 30-minute sessions of PST, chosen from the CHIP Study Parent Support Skills Training for Concussion recovery based on the parent's goals in the Introduction Session.
BEHAVIORAL
Care management
In the CM component, parents are provided support regarding advocating for their child's needs across different contexts in the healthcare system, school and athletic departments (including guidance regarding medication referrals), using applied problem-solving together with the skills coach to address emergent needs. Adolescents can also be involved in CM, if developmentally appropriate based on their age, independence, and interest. Of note, while the CM component engages youth and parents, treatment effects are hypothesized to result from facilitating access to supportive services including medication referrals at the organizational level. Families randomized to receive this component will participate in six 30-minute sessions of CM, following the guidelines in the CHIP Care Management Manual.
Primary outcome measures
Health Behavior Inventory (HBI)
Time frame: 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)
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 11-18 years old
- Health care provider diagnosed concussion within 1-12 months ≥ 3 new onset or worsening post-concussive symptoms (measured with the HBI)
- Can be located anywhere as study is all completed remotely
Exclusion criteria
- 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
Where
- Dallas, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center, University of Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2025 · Source of record for eligibility and locations