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/Actively Recruiting
Led by Seattle Children's Hospital · Updated on 2025-03-13
304
Participants Needed
1
Research Sites
N/A
Total Duration
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
S
Sara P Chrisman, MD MPH
C
Carolyn McCarty, PhD
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Seattle Children's Hospital
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Cognitive Behavioral Therapy, Parent Skills Training, and Care Management | Cognitive Behavioral Therapy and Parent Skills Training | Cognitive Behavioral Therapy and Care Management | Parent Skills Training and Care Management | Cognitive Behavioral Therapy Only | Parent Skills Training Only | Care Management Only | No Intervention (Usual Care) |
|---|---|---|---|---|---|---|---|---|
| What are the interventions or study conditions? | Participants receive concussion-focused cognitive behavioral therapy, parent skills training, and care management behavioral interventions. | Participants receive concussion-focused cognitive behavioral therapy and parent skills training without care management. | Participants receive concussion-focused cognitive behavioral therapy with care management but without parent skills training. | Participants receive parent skills training and care management, without cognitive behavioral therapy. | Participants receive only concussion-focused cognitive behavioral therapy. | Participants receive only parent skills training intervention. | Participants receive only care management intervention. | Participants do not receive any CHIP behavioral interventions and represent usual care or monitoring. |
| Role in the study | Assigned to the CHIP full multi-component behavioral intervention arm. | Assigned to receive a combination of cognitive behavioral therapy and parent skills training. | Assigned to receive cognitive behavioral therapy and care management only. | Assigned to receive parent skills training and care management only. | Assigned to receive only concussion-focused cognitive behavioral therapy. | Assigned to receive only parent skills training. | Assigned to receive only care management intervention. | Assigned to the no-intervention arm, which reflects usual care or monitoring within the trial. |
| Main purpose or intended benefit | Designed to improve recovery from persistent post-concussive symptoms and daily functioning in adolescents. | Targeted to reduce post-concussive symptoms and improve adolescent functioning. | Aims to decrease symptoms and improve outcomes in youth using therapy and care management. | Aims to enhance parent support and access to care to benefit youth recovery. | Intended to help youth manage and reduce post-concussive symptoms. | Intended to build positive parenting approaches to support adolescent recovery. | Intended to facilitate access to supportive care and address recovery needs through care management. | Represents standard or usual care; participants do not receive any CHIP behavioral interventions. |
| How are the interventions given? | Six 30-minute remote sessions of each intervention provided individually to both adolescent and parent, with modules selected based on participant goals. | Six 30-minute remote sessions each for cognitive behavioral therapy and parent skills training, modules tailored by participant goals. | Six 30-minute remote sessions for both cognitive behavioral therapy and care management; content tailored to participant needs. | Six 30-minute remote sessions each for parent training and care management; modules customized per goals. | Six 30-minute remote sessions with an interventionist selected from cognitive and behavioral skills modules. | Six 30-minute remote sessions for parents, with in-vivo skills practice and feedback, tailored to parent goals. | Six 30-minute remote sessions focused on supporting the family in navigating recovery contexts and needs. | No behavioral intervention; participants receive routine care or monitoring as usual. |
| What is already known from research? | The effectiveness of delivering all three CHIP behavioral components together for adolescents with persistent post-concussive symptoms is currently unknown; this is being tested in the trial. | Combination cognitive behavioral therapy and parent skills training for post-concussive symptoms in youth is investigational, with no established published patient outcomes for this pairing. | This combination is under investigation and results of efficacy are not yet established from published clinical research. | No published outcomes for parent skills training combined with care management for this population; ongoing evaluation in trial. | Concussion-focused cognitive behavioral therapy for post-concussive symptoms is investigational, with active research underway to determine its effectiveness. | Parent skills training for youth with post-concussive symptoms is investigational; outcome data not yet established. | Care management for this indication is investigational; patient outcome evidence is not yet established. | Usual care serves as the control group in recent randomized studies. Prior trials show that collaborative care or behavioral interventions may improve outcomes compared to usual care, but routine management alone does not reliably resolve persistent symptoms for all adolescents. |
| Key limitations or gaps | Unknown whether combining all behavioral components leads to greater benefit than single or dual components; individual contribution of each intervention is under study. | Specific effects of the combination are not established, and results for this combination are not yet available. | Relative benefit of this combination compared to others, and compared to usual care, is unknown. | Lack of current evidence for the combined effect of parent skills training plus care management in this setting. | Effectiveness of cf-CBT alone for persistent post-concussive symptoms remains under investigation. | Effectiveness of parent skills training alone for post-concussive symptoms is unknown. | Care management alone has not been established as effective for adolescent post-concussive symptoms. | Usual care may not provide structured behavioral support shown beneficial in recent trials; may leave some adolescents with ongoing symptoms. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor