Concussion Health Improvement Program
CHIP
Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms
2 other identifiers
interventional
304
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
November 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 13, 2025
March 1, 2025
4.2 years
September 6, 2023
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Health Behavior Inventory (HBI)
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).
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Pediatric Quality of Life Inventory (PedsQL)
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).
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Secondary Outcomes (6)
Generalized Anxiety Disorder-7 item (GAD-7)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Patient Health Questionnaire-9 item (PHQ-9)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Adolescent Sleep Wake Scale-10 item (ASWS-10)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Pediatric Inventory for Parents (PIP)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Headache daily diary
Trajectory over one year (baseline, 3 months, 6 months, 1 year)
- +1 more secondary outcomes
Other Outcomes (3)
Parent-Patient Activation Measure (P-PAM)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Generalized self-efficacy (GSE)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Adult responses to child's symptoms (ARCS)
Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Study Arms (8)
Pathway 1
EXPERIMENTALAll interventions: cf-CBT, PST \& CM
Pathway 2
EXPERIMENTALcf-CBT \& PST
Pathway 3
EXPERIMENTALcf-CBT \& CM
Pathway 4
EXPERIMENTALcf-CBT only
Pathway 5
EXPERIMENTALPST \& CM
Pathway 6
EXPERIMENTALPST only
Pathway 7
EXPERIMENTALCM only
Pathway 8
NO INTERVENTIONNo interventions
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern (UTSW)
Dallas, Texas, 75390, United States
Related Publications (3)
Nechitailenko PA. [Various circulatory and external respiratory reactions with different methods of dosed swimming]. Vopr Kurortol Fizioter Lech Fiz Kult. 1972 Mar-Apr;37(2):170-2. No abstract available. Russian.
PMID: 5051206BACKGROUNDMcCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207.
PMID: 33635325BACKGROUNDMcCarty CA, Hennings T, Zhou C, Law EF, Zatzick D, Chrisman SPD. Concussion Health Improvement Program (CHIP): study protocol for a randomized controlled optimization trial for youth with persistent post-concussive symptoms. Trials. 2024 Oct 9;25(1):668. doi: 10.1186/s13063-024-08494-y.
PMID: 39385279DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara P Chrisman, MD MPH
Seattle Children's Hospital
- PRINCIPAL INVESTIGATOR
Carolyn A McCarty, PhD
Seattle Children's Hospital
Central Study Contacts
Carolyn McCarty, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Outcomes are all assessed via self-report so masking of research team is not necessary. Participants and interventionists cannot be masked as to what intervention the participants receiving.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 13, 2023
Study Start
November 10, 2023
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share