Recruiting

Concussion Health

Sponsor:

Seattle Children's Hospital

Code:

NCT06036147

Conditions

Concussion, Brain

Brain Injury Traumatic Mild

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

Concussion-focused cognitive behavioral therapy

Parent skills training

Care management

Study Details

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.

Conditions

Concussion, Brain

Brain Injury Traumatic Mild

Study ID

NCT06036147

Start date

Nov 10, 2023

Status verified date

Mar, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pathway 1

All interventions: cf-CBT, PST \& CM

experimental: Pathway 2

cf-CBT \& PST

experimental: Pathway 3

cf-CBT \& CM

experimental: Pathway 4

cf-CBT only

experimental: Pathway 5

PST \& CM

experimental: Pathway 6

PST only

experimental: Pathway 7

CM only

no intervention: Pathway 8

No interventions

Interventions

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.

Primary outcome measure

  • Health Behavior Inventory (HBI) [ Time Frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) ]
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) ]

Central Contacts and Locations

Central contacts

Sara P Chrisman, MD MPH

(206) 987-2028chip@seattlechildrens.org

Locations

University of Texas Southwestern (UTSW)

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Nyaz Didehbani, PhD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2025-03-13.