COACH Intervention for Concussion Prevention

(COACH Trial)

Overseen By Konstantia Strates

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Braces, Dental appliances, others

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

Compensation: Varies

Number of Visits: 1

880 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the COACH Intervention for Concussion Prevention treatment?

The CDC HEADS UP materials, which are part of concussion education for coaches, have been shown to improve communication about concussion safety and increase knowledge among youth sports coaches. This suggests that educational interventions like COACH could be effective in reducing concussion risks by enhancing awareness and communication. ^{1 2 3 4 5}

How does the COACH Intervention treatment differ from other treatments for concussion prevention?

The COACH Intervention is unique because it focuses on aligning communities to reduce concussion and head impact exposure through education and awareness, rather than just treating symptoms after they occur. This approach is different from traditional methods that primarily focus on symptom management and return-to-play protocols. ^{2 6 7 8 9}

What is the purpose of this trial?

Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.

Research Team

Jillian Urban, PhD, MPH

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for youth football organizations that are interested in adopting a safety program called COACH. The goal is to improve coach knowledge and skills, change attitudes, and promote safe practices to prevent head impacts and concussions.

Inclusion Criteria

Participants without braces

Exclusion Criteria

Athletes will be excluded if they have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance)

I do not have braces and do not plan to get them during the football season.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-season Intervention

Implementation of the COACH program to improve knowledge and skills of youth football coaches in effective practice planning

Pre-season

1 visit (in-person)

In-season Monitoring

Monitoring of head impacts and implementation fidelity during the football season

3 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention

Trial Overview The study tests the COACH intervention's effectiveness in reducing head impacts and concussion rates among young football players. It also evaluates how well youth football groups can adopt this program and its impact on brain health.

Participant Groups

Group I: practice intervention Experimental Treatment 1 Intervention

head impact outcomes will be monitored from athletes enrolled on teams participating in the COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) intervention

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A pilot study involving 21 family physicians showed that training on new return-to-activity guidelines after concussion significantly increased physicians' knowledge (from 6.3 to 8.8 correct answers out of 10) and adherence to the guidelines (from 25% to 86%).

Despite the positive changes in knowledge and adherence, the study faced challenges in recruitment and retention, indicating that improvements are needed for a larger trial to effectively implement these guidelines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. Silverberg, ND., Otamendi, T., Panenka, WJ., et al.[2023]

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]

References

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

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]

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

Randomized Evaluation of Centers for Disease Control and Prevention HEADS UP Concussion Education Materials for Youth Sport Coaches. [2023]

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

Awareness of the CDC "Heads Up!" to Youth Sports Campaign among Pediatric Sports Coaches: A Pilot Survey Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Qualitative assessment of the use of a smart phone application to manage post-concussion symptoms in Veterans with traumatic brain injury. [2021]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Prevention strategies and modifiable risk factors for sport-related concussions and head impacts: a systematic review and meta-analysis. [2023]

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

Prevalence of Suspected Concussions Among K-12 Students in Utah: Findings From Utah's Student Injury Reporting System. [2023]

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

Effect of Coach Feedback and Awareness of Head Impact Exposure on Practice Structure in Youth Football. [2023]

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

Concussion Incidence, Duration, and Return to School and Sport in 5- to 14-Year-Old American Football Athletes. [2020]