Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial.
Carolyn A McCarty, Douglas Zatzick, Elizabeth Stein...
https://pubmed.ncbi.nlm.nih.gov/27624513Actively Recruiting
Led by Seattle Children's Hospital · Updated on 2025-03-13
304
Participants Needed
1
Research Sites
N/A
Total Duration
S
Seattle Children's Hospital
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
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
Concussion Health Improvement Program
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual)
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
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
Total: 1 location
1
University of Texas Southwestern (UTSW)
Dallas, Texas, United States, 75390
Actively Recruiting
S
Sara P Chrisman, MD MPH
C
Carolyn McCarty, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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