Viewing Study NCT06624202



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06624202
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-01

Brief Title: COmmunities Aligned to Reduce Concussion and Head Impact Exposure
Sponsor: None
Organization: None

Study Overview

Official Title: COmmunities Aligned to Reduce Concussion and Head Impact Exposure COACH
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COACH
Brief Summary: 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
Detailed Description: Football has a high risk of concussion and incidence of subconcussive head impacts which have long-lasting negative effects on brain health With roughly 35 million athletes participating in youth football each year there is a critical need to reduce head impact exposure and concussion risk Over an entire season most of an athletes head impact exposure is attributed to practice Coach-directed activities eg practice drills influence the frequency and severity of head impact exposure Practices are amenable to intervention however youth football leagues are often community-run organizations with limited resources making implementation and enforcement of injury prevention strategies a challenge Thus engaging community members is essential for successful development implementation and sustenance of interventions This study partnered with a community stakeholder group to co-design and implement an evidence-based intervention program COmmunities Aligned to reduce Concussion and Head impact exposure COACH COACH seeks to improve knowledge and skills of youth football coaches in effective practice planning that incorporates safe drills and to change attitudes and beliefs toward contact in practice COACH has been pilot tested in two teams and shown to be acceptable and feasible A critical next step of this research is the pragmatic evaluation of the effectiveness of COACH on a larger scale while identifying factors that influence implementation This study addresses this critical next step by determining the capacity of youth football organizations to adopt COACH and by testing COACHs effectiveness while monitoring the implementation process

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None