Concussion Health Improvement Program

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.

Conditions

• Concussion, Brain
• Brain Injury Traumatic Mild

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Sara P Chrisman, MD MPH · Seattle Children's Hospital

• Carolyn A McCarty, PhD · Seattle Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

11 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-10

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• United States

Study Locations