Cognitive Behavioral Therapy + Parent Skills Training for Concussions

(CHIP Trial)

Overseen By Carolyn McCarty, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Suicidal ideation, Psychosis, Spinal cord injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of treatments to assist young people with lingering symptoms after a concussion. It includes concussion-focused cognitive behavioral therapy (a type of talk therapy), parent skills training, and care management (also known as case management or care coordination) to determine which components are most effective. The goal is to improve recovery and quality of life for children experiencing these symptoms. The trial is suitable for youth ages 11-18 who have had a concussion diagnosed by a healthcare provider in the past 1-12 months and are experiencing three or more ongoing symptoms. Participants can join the trial from anywhere, as all sessions occur remotely. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment strategies for young people with concussion symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive behavioral therapy (CBT) can help treat post-concussion symptoms. Studies indicate that CBT, combined with education about the condition and other therapies, is generally well-received. However, some research questions its effectiveness in reducing symptom severity.

Parent skills training (PST) is another method under exploration. Although specific data on PST for concussions is limited, similar programs for managing traumatic brain injury (TBI) have shown positive results. These programs teach parents how to better support their children, potentially aiding recovery.

Care management (CM) is commonly used in healthcare to organize and simplify patient care. For mild traumatic brain injuries (mTBI), care management ensures patients receive appropriate support and monitoring. This method is generally safe and has proven effective in other health conditions.

Overall, these treatments are non-invasive and focus on behavioral and supportive strategies. They are well-tolerated and carry a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to treating concussions, which are typically managed with rest and gradual return to activities. This trial combines cognitive behavioral therapy (CBT) focused on concussion recovery with parent skills training and care management. The unique aspect is the integration of psychological and educational strategies to address both the patient's and family's needs. By involving parents and focusing on cognitive recovery, this approach aims to enhance the healing process and support system, potentially offering a more holistic and effective recovery strategy than standard care alone.

What evidence suggests that this trial's treatments could be effective for youth with persistent post-concussive symptoms?

Research has shown that cognitive behavioral therapy (CBT) can alleviate symptoms of long-lasting post-concussion syndrome, though results may vary. One study found that CBT did not significantly reduce symptom severity in adults, yet it remains a valuable method for managing mood and behavior changes. In this trial, some participants will receive concussion-focused CBT alone or combined with other interventions.

Training for parents has shown promise in enhancing parenting skills and reducing stress and anxiety for parents of children with brain injuries. This suggests it might also help parents better manage their child's post-concussion symptoms. Participants in this trial may receive parent skills training alone or alongside other treatments.

Care management, which organizes and coordinates healthcare services, has proven practical and possibly effective in managing brain injuries. This approach could enhance treatment efficiency and improve outcomes for young people with long-term post-concussion symptoms. In this trial, care management is offered as a standalone treatment or combined with other interventions. ^{4 5 6 7 8}

Who Is on the Research Team?

Sara P Chrisman, MD

Principal Investigator

Seattle Children's Hospital

Carolyn A McCarty, PhD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young people aged 11-18 who've been diagnosed with a concussion by a healthcare provider within the past 1-6 months and are experiencing at least three new or worsening symptoms after their injury.

Inclusion Criteria

I was diagnosed with a concussion in the last 1-6 months and have 3 or more new or worsening symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a collaborative care intervention including cf-CBT, PST, and CM, delivered virtually over three months

12 weeks

Sessions via video conferencing

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys completed at multiple time points

12 months

Surveys at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Care management
• Concussion-focused cognitive behavioral therapy
• Parent skills training

Trial Overview The study tests a treatment combining cognitive therapy, parent skills training, and care management to help youths recover from post-concussive symptoms. Participants will be randomly assigned to one of eight groups to determine which parts of the treatment are most effective.

How Is the Trial Designed?

Group I: Pathway 7 Experimental Treatment 1 Intervention

CM only

Group II: Pathway 6 Experimental Treatment 1 Intervention

PST only

Group III: Pathway 5 Experimental Treatment 1 Intervention

PST \& CM

Group IV: Pathway 4 Experimental Treatment 2 Interventions

cf-CBT only

Group V: Pathway 3 Experimental Treatment 2 Interventions

cf-CBT \& CM

Group VI: Pathway 2 Experimental Treatment 2 Interventions

cf-CBT \& PST

Group VII: Pathway 1 Experimental Treatment 3 Interventions

All interventions: cf-CBT, PST \& CM

Group VIII: Pathway 8 Active Control 1 Intervention

No interventions

Care management is already approved in United States, European Union for the following indications:

Approved in United States as Care Management for:

• General healthcare management
• Chronic condition management
• Post-concussive syndrome management

Approved in European Union as Care Management for:

• General healthcare management
• Chronic condition management
• Post-concussive syndrome management

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Parent-child interaction therapy (PCIT) was successfully applied to an 11-year-old boy with externalizing behaviors following a severe traumatic brain injury, demonstrating its adaptability beyond the typical age range.

After 9 sessions of PCIT, the child showed a significant reduction in negative behaviors, and his mother experienced less distress, indicating the therapy's effectiveness in improving family dynamics post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy as a family-oriented approach to behavioral management following pediatric traumatic brain injury: a case report. Cohen, ML., Heaton, SC., Ginn, N., et al.[2012]

The Brain Injury Partners intervention significantly improved parents' knowledge, skill application, and attitudes towards advocacy for their children with traumatic brain injury, as shown in a randomized trial with 31 participants.

Parents who used the Brain Injury Partners CD-ROM felt more confident and prepared to communicate effectively with school personnel compared to those who used a control CD-ROM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using interactive multimedia to teach parent advocacy skills: an exploratory study. Glang, A., McLaughlin, K., Schroeder, S.[2007]

Psychoeducation and cognitive strategy instruction are effective treatment components for addressing prolonged concussion symptoms (PCS), particularly for cognitive impairments in attention, working memory, and executive functioning.

A personalized, dynamic approach to managing PCS, which includes individualized tracking of progress and treatment adaptation based on client performance, shows promise in effectively targeting functional goals disrupted by concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. Wright, J., Sohlberg, MM.[2021]

A study involving 774 parents developed reliable and valid survey measures to assess parents' knowledge and self-efficacy regarding concussion management for their children, based on CDC guidelines.

Higher self-efficacy scores among parents were positively correlated with their likelihood of engaging in recommended concussion management behaviors, indicating that boosting parents' confidence can enhance their support during their child's recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Measure of Parent Concussion Management Knowledge and Self-Efficacy. Kroshus, E., Steiner, MK., Lowry, SJ., et al.[2023]

A pilot study involving 66 parents of children aged 5 to 16 with concussions found that early telephone counseling did not significantly reduce postconcussion symptoms or family stress compared to usual care at 3 months post-injury.

The results suggest that the counseling intervention may not be effective for managing postconcussion symptoms, indicating a need for further research into more intensive care strategies for affected children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Early Follow-Up Intervention on Parent-Reported Postconcussion Pediatric Symptoms: A Feasibility Study. Mortenson, P., Singhal, A., Hengel, AR., et al.[2018]

A time-limited and intensive format of Parent-Child Interaction Therapy (PCIT) was found feasible for 15 families with young children aged 2-5 years who had experienced a traumatic brain injury (TBI) and exhibited behavior problems.

The intervention led to high caregiver satisfaction and significant reductions in child behavior issues, with 71% of families completing the program and showing improvements at post-assessment and follow-up, suggesting it may effectively address challenges following early childhood TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Parent-Child Interaction Therapy for Children with Traumatic Brain Injury: Feasibility Study. Garcia, D., Rodríguez, GM., Lorenzo, NE., et al.[2022]

A collaborative care intervention model that includes cognitive-behavioral therapy and care management significantly reduced postconcussive symptoms in adolescents aged 11 to 17 over 6 months, with only 13% of intervention patients reporting high levels of symptoms compared to 41.7% in the control group.

The intervention also led to a notable improvement in depression symptoms, with 78% of those receiving collaborative care experiencing a reduction of 50% or more, while no significant changes were observed in anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. McCarty, CA., Zatzick, D., Stein, E., et al.[2018]

The CARE4PCS-II study is a randomized trial involving 200 adolescents aged 11-18 with persistent post-concussive symptoms, designed to evaluate the effectiveness of a collaborative care intervention that includes cognitive-behavioral therapy and care management compared to usual care.

This innovative approach aims to improve outcomes related to post-concussive, depressive, and anxiety symptoms over a 12-month period, potentially offering a new model for managing persistent symptoms in youth after sports-related concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial. McCarty, CA., Zatzick, D., Hoopes, T., et al.[2020]

A new treatment-based profiling model has been proposed to assist physical therapists in managing patients after a concussion, focusing on symptom type, intensity, and movement response.

The model emphasizes three key treatment areas: symptom management, movement system optimization, and performance optimization, which can help therapists make informed decisions tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. Alsalaheen, B., Landel, R., Hunter-Giordano, A., et al.[2020]

A study involving 42 emergency department clinicians identified six key themes that influence the implementation of a clinical pathway for managing pediatric concussions, emphasizing the need for standardization amidst evolving research and clear communication of goals.

The findings suggest that successful implementation of concussion management pathways requires a team-oriented approach, effective knowledge dissemination, and alignment of information among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"What is the actual goal of the pathway?": examining emergency department physician and nurse perspectives on the implementation of a pediatric concussion pathway using the theoretical domains framework. Ly, A., Zemek, R., Wright, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7672813/

Case management after acquired brain injury compared to ... In this study, we aim to evaluate the feasibility of case management after acquired brain injury and its effectiveness and cost-effectiveness, compared to care ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S000399931931305X

Management of Concussion and Mild Traumatic Brain Injury The article offers guidance on key clinical decisions in mTBI care and highlights priority interventions that can be initiated in primary care to prevent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127701/

Overview of Treatment Options for Mild Traumatic Brain Injury This literature review aims to provide insight into concussions, the current treatment options available, and the new developments in concussions.

4. tandfonline.com tandfonline.com/doi/full/10.1080/02699052.2024.2399070

Case management for people with acquired brain injury Case management (CM) aims to facilitate access to and integration of health care and social services. We investigated the feasibility and effectiveness of CM.

5. aafp.org aafp.org/pubs/afp/issues/2019/0401/p426.html

Current Concepts in Concussion: Initial Evaluation and ... Initial evaluation involves eliminating concern for cervical spine injury and more serious traumatic brain injury before diagnosis is established.

6. cdc.gov cdc.gov/traumatic-brain-injury/data-research/index.html

TBI Data | Traumatic Brain Injury & Concussion CDC collects and reports TBI data to understand: how many people are affected by this injury, who is most at risk, the leading ways a person may get a TBI,

7. cdc.gov cdc.gov/traumatic-brain-injury/hcp/data-research/index.html

Mild TBI Management Guideline | Traumatic Brain Injury & ... View the updated Mild Traumatic Brain Injury (mTBI) Management Guideline for Adults and other educational tools including patient discharge instructions.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537017/

Concussion - StatPearls - NCBI Bookshelf - NIH A concussion is a traumatically induced transient disturbance of brain function. Concussions are a subset of the neurologic injuries known as traumatic brain ...