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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help youth football coaches prevent head injuries through a safety program designed to reduce head impacts during practices and games. The program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention, equips coaches with the tools and knowledge to plan safer practices and change attitudes about head safety. The trial tests whether this program can lower the number of head impacts and concussions among young athletes. It seeks participants who play football and do not have braces or certain dental appliances that might interfere with the study's equipment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance safety in youth sports.

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 prior data suggests that the COACH intervention is safe for youth football players?

Research shows that the COACH Intervention is designed to make youth football practices safer by reducing head impacts and possible concussions. It teaches coaches how to plan safer practices. Community input helped create this program, ensuring it meets real-world needs.

There are no safety concerns with the intervention itself because COACH is not a drug or medical device. It is an educational program that changes how practices are conducted to reduce head injuries. The focus on teaching better techniques and safety awareness poses no risks to participants.

Overall, past studies have shown that activities directed by coaches can affect the frequency and severity of head impacts. By emphasizing education and awareness, COACH aims to make the sport safer for young athletes without any reported negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional approaches that focus on treating concussions after they occur, the COACH Intervention is unique because it aims to prevent concussions and reduce head impacts in the first place. Researchers are excited about this method because it involves aligning entire communities, including athletes and sports teams, to proactively monitor and manage head impact exposure. This collaborative and preventative approach is different from typical post-injury treatments and has the potential to significantly decrease the incidence of concussions in sports.

What evidence suggests that the COACH intervention is effective for reducing head impacts and concussions in youth football?

Research has shown that the COACH program (COmmunities Aligned to reduce Concussion and Head impact exposure) aims to make youth football safer. Early findings suggest that the program reduces head impacts by teaching coaches to plan safer practices. Studies have found that when coaches gain knowledge and adjust their attitudes, sports become safer. Evidence supports that COACH may lower the risk of head injuries by promoting better safety practices. Early results are promising, and the program seeks to protect brain health by reducing the chances of concussion. ^{1 2 3 4 6}

Who Is on the Research Team?

Jillian Urban, PhD, MPH

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06624202

COmmunities Aligned to Reduce Concussion and Head ... This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11440239/

Protocol for COACH, an evidence-based intervention ... Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06368050/implementation-of-an-evidence-based-intervention-to-improve-head-impact-safety-in-youth-football?activelyRecruiting=false&page=47&id=590&slug=brain-injury

Implementation of an Evidence-Based Intervention to ... The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to ...

4. researchgate.net researchgate.net/publication/384083029_Protocol_for_COACH_an_Evidence-based_Intervention_for_Improved_Head_Impact_Safety_in_Youth_American_Football_Developed_Using_a_Community-Engaged_Approach

Protocol for COACH, an Evidence-based Intervention ... The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39351080/

Protocol for COACH, an evidence-based intervention for ... The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American ...

6. withpower.com withpower.com/trial/phase-concussions-5-2025-ec671

COACH Intervention 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, ...