Study Results
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Basic Information
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RECRUITING
NA
304 participants
INTERVENTIONAL
2023-11-10
2028-01-31
Brief Summary
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Detailed Description
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The investigators are now striving to optimize the CC approach by assessing the contribution of each component in order to increase efficiency and scalability while maximizing effectiveness. They have chosen to view the CC intervention treatment effects using the frame of the Socioecological Model,16 postulating that cf-CBT targets the individual level, PST targets the interpersonal level (i.e., relationships with parents) and CM targets the organizational level (i.e., linkages to medical, school, and other services). They have also worked to amplify each component, noting in previous trials that concussive symptoms, sleep and HRQoL improved significantly in the intervention group compared to usual care, without a concomitant improvement in headache. In response, they increased the focus on skills for managing headache in the cf-CBT and PST components, with the guidance of a pain psychologist. They also increased the rigor and structure of all components with greater oversight regarding delivery and duration. The next step is to assess the separate contribution of each different leveled component (cf-CBT, PST and CM) to determine their impact on youth and parent outcomes.
The investigators propose to conduct an optimization trial with the CC approach for youth with PPCS, utilizing a highly efficient analytic approach, the multiphase optimization strategy (MOST).The design will be factorial, with three components (cf-CBT, PST and CM) each with two levels (present or absent). They will recruit adolescents aged 11-18 with PPCS lasting at least 1 month from outpatient clinics, randomizing families to one of 8 groups to assess all combinations of treatment components. Families will participate in sessions virtually and complete surveys at 3, 6 and 12 months to measure proximal and distal outcomes. They will examine potential mechanisms of action for each component and explore differential effectiveness across baseline factors via moderation. They will sample youth from two distinct geographic regions to enhance diversity and improve generalizability.
Aim 1. Determine which components of the CC approach (cf-CBT, PST and CM) contribute significantly to improvements in distal outcomes, particularly concussive symptoms and youth HRQoL, among a diverse sample of youth with PPCS.
1a. Examine the effect of intervention components on proximal outcomes including youth headache, mood and sleep, and parental distress regarding their child's illness.
Aim 2. Assess potential mediation of intervention component effects by postulated mechanistic factors including improvements in a) youth self-efficacy, b) parental protectiveness and c) parental self-efficacy regarding navigating their child's concussion care.
Aim 3. Explore moderation of intervention component effects by demographic (parental education level, youth race/ethnicity, youth sex) and clinical factors (youth depression and level of parent emotional distress).
The proposed study will advance concussion research by continuing to refine an evidence-based intervention for youth with PPCS that addresses mental health, while engaging both parents and youth. It will also elucidate the scientific understanding of how the intervention works, and for whom. The end product of this research will be a PPCS intervention optimized for effectiveness and efficiency that will form the basis for a future hybrid implementation effectiveness trial.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Participants and interventionists cannot be masked as to what intervention the participants receiving.
Study Groups
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Pathway 1
All interventions: cf-CBT, PST \& CM
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.
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.
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.
Pathway 2
cf-CBT \& PST
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.
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.
Pathway 3
cf-CBT \& CM
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.
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.
Pathway 4
cf-CBT only
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.
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.
Pathway 5
PST \& CM
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.
Pathway 6
PST only
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.
Pathway 7
CM only
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.
Pathway 8
No interventions
No interventions assigned to this group
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Texas Southwestern Medical Center
OTHER
University of Washington
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Sara PD Chrisman, MD MPH
Associate Professor
Principal Investigators
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Sara P Chrisman, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Carolyn A McCarty, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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University of Texas Southwestern (UTSW)
Dallas, Texas, United States
Countries
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Central Contacts
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Carolyn McCarty, PhD
Role: CONTACT
Facility Contacts
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Nyaz Didehbani, PhD
Role: primary
References
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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.
McCarty 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.
McCarty 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.
Related Links
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Study website
Other Identifiers
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00004199
Identifier Type: -
Identifier Source: org_study_id
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