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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy + Parent Skills Training for Concussions?

Research suggests that cognitive strategy instruction and psychoeducation can help manage prolonged concussion symptoms by improving attention and memory. Additionally, parent-child interaction therapy has shown promise in managing behavioral issues in children with brain injuries, which may be relevant for concussion recovery. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy + Parent Skills Training for Concussions safe for humans?

The research includes studies on cognitive-behavioral therapy and parent skills training for conditions like postconcussive symptoms and traumatic brain injury, suggesting these approaches are generally safe for humans. ^{1 3 6 7 8}

How is the treatment for concussions involving Cognitive Behavioral Therapy and Parent Skills Training different from other treatments?

This treatment is unique because it combines cognitive behavioral therapy (a type of talk therapy) specifically focused on concussions with training for parents to help them support their child's recovery, which is not commonly included in standard concussion treatments. ^{1 3 6 9 10}

Research Team

Carolyn A McCarty, PhD

Principal Investigator

Seattle Children's Hospital

Sara P Chrisman, MD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

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]

References

1. United States 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. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Intensive Parent-Child Interaction Therapy for Children with Traumatic Brain Injury: Feasibility Study. [2022]

4. England 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Early Follow-Up Intervention on Parent-Reported Postconcussion Pediatric Symptoms: A Feasibility Study. [2018]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Development of a Measure of Parent Concussion Management Knowledge and Self-Efficacy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Using interactive multimedia to teach parent advocacy skills: an exploratory study. [2007]