Clinical trial NCT06036147: Concussion Health Improvement Program
Official title: Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Brain
Brain Injury Traumatic Mild
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Texas Southwestern Medical Center
name: University of Washington
First posted: 2023-09-13
Enrollment: 304
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Youth are randomized into one of 8 pathways which are all combinations of three intervention approaches.
Primary purpose: TREATMENT

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.

Detailed description: Concussion is common among adolescents, affecting up to 1.9 million U.S. youth per year. Although many youth recover quickly, up to 30% experience difficulty concentrating, headache, sleep disruption and other symptoms extending one month or longer, characterized as persistent post-concussive symptoms (PPCS). Youth with PPCS can have symptoms for months, leading to declines in academic function and quality of life, as well as excessive healthcare costs. Research indicates mental health comorbidity is linked to greater likelihood of prolonged concussive symptoms, however evidence regarding mental health interventions for PPCS is still developing and mental health approaches are not included in the standard of care. The investigators successfully adapted and tested a mental health intervention for youth with PPCS involving collaborative care (CC) delivery of youth concussion-focused cognitive-behavioral therapy (cf-CBT), parenting skills training (PST) and care management (CM), with medication guidance as needed. We completed an R01 level randomized controlled trial of the CC approach for youth with PPCS, finding evidence for long-term gains; those receiving CC had improvements at 12 months in concussion symptoms (Cohen's d=0.32) and health-related quality of life (HRQoL) (Cohen's d=0.29) compared to usual care. Perhaps most importantly, more than half of families (60%) completed the intervention entirely virtually, expanding accessibility. While our multicomponent CC approach was effective, research suggests duration and complexity of evidence-based mental health interventions affect the likelihood of successful implementation and dissemination.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Behavior Inventory (HBI)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 item (GAD-7)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Patient Health Questionnaire-9 item (PHQ-9)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Adolescent Sleep Wake Scale-10 item (ASWS-10)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Pediatric Inventory for Parents (PIP)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Headache daily diary
timeFrame: Trajectory over one year (baseline, 3 months, 6 months, 1 year)
measure: Mood daily diary
timeFrame: Trajectory over one year (baseline, 3 months, 6 months, 1 year)
Other outcomes:
measure: Parent-Patient Activation Measure (P-PAM)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Generalized self-efficacy (GSE)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
measure: Adult responses to child's symptoms (ARCS)
timeFrame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern (UTSW)
state: Texas
Study officials:
affiliation: Seattle Children's Hospital
name: Sara P Chrisman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Carolyn A McCarty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.