Actively Recruiting

Phase Not Applicable
Age: 11Years - 18Years
All Genders
ID06036147

Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms

Led by Seattle Children's Hospital · Updated on 2025-03-13

304

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Seattle Children's Hospital

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a collaborative care approach for adolescents aged 11 to 18 with persistent post-concussive symptoms (PPCS) lasting at least one month after a concussion. This condition affects many youth, causing symptoms like difficulty concentrating, headaches, and sleep problems, which can lead to academic and social challenges. The study aims to optimize mental health treatments by assessing the effectiveness of three components: concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST), and care management (CM). This trial uses a factorial design to understand the contribution of each component in improving symptoms and quality of life. Participants will be randomly assigned to one of eight groups that include different combinations of the three treatment components or no intervention. Each component involves six 30-minute sessions delivered via video conferencing over three months. The cf-CBT focuses on teaching youth coping and relaxation skills, PST helps parents support their child through positive parenting and communication techniques, and CM assists families in accessing healthcare, school, and athletic support services. This design allows researchers to evaluate which parts of the intervention are most beneficial and efficient. Throughout the study, youth and parents will complete surveys at 6 weeks, 3 months, 6 months, and 12 months to assess outcomes like concussion symptoms, quality of life, sleep, pain, mood, and parental distress. The study will monitor the progress of these outcomes and explore factors that influence treatment effects. Participation is fully remote, enabling families to take part from any location. The goal is to develop a streamlined, effective intervention that can be widely implemented for youth with PPCS.

CONDITIONS

Brief Title

Concussion Health Improvement Program

Who Can Participate

Age: 11Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 11 to 18 years old
  • Diagnosed with concussion by a healthcare provider within the past 1 to 12 months
  • Have at least 3 new or worsening post-concussive symptoms
  • Able to participate remotely from any location
Not Eligible

You will not qualify if you...

  • Active suicidal thoughts, psychosis, or psychiatric hospitalization in the past 6 months
  • Spinal cord injury or other severe illness preventing participation
  • Not fluent in English or Spanish
  • Chronic illness or medical condition that prevents concussion-focused treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (virtual)

Treatment

Duration - 6 sessions over several weeks

Participants receive one or more behavioral intervention components for persistent post-concussive symptoms, including concussion-focused cognitive behavioral therapy, parent skills training, and care management, delivered virtually in six 30-minute sessions tailored to individual goals.

6 virtual sessions

Follow-up

Duration - 12 months

Participants complete virtual surveys to measure concussion symptoms, quality of life, mood, sleep, and parental distress at multiple timepoints to assess treatment outcomes and mechanisms of action.

Surveys at baseline, 6 weeks, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

University of Texas Southwestern (UTSW)

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

S

Sara P Chrisman, MD MPH

C

Carolyn McCarty, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

8

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Published Research Related To This Trial

Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial.

Carolyn A McCarty, Douglas F Zatzick, Lyscha A Marcynyszyn...

https://pubmed.ncbi.nlm.nih.gov/33635325

Concussion Health Improvement Program (CHIP): study protocol for a randomized controlled optimization trial for youth with persistent post-concussive symptoms.

Carolyn A McCarty, Tayler Hennings, Chuan Zhou...

https://pubmed.ncbi.nlm.nih.gov/39385279