CompletedNot Applicable

Reducing Head Impact Exposure in Hawaii High School Football

United States496 participantsStarted 2019-07-22

Plain-language summary

This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.

Who can participate

Age range

14 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams Exclusion Criteria: * none

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Head Impact Exposure Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Neurocognitive performance Change from Baseline

Timeframe: Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Self-report Symptom Scores Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October)

Trial details

NCT IDNCT04020874

SponsorUniversity of Massachusetts, Lowell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-29

View on ClinicalTrials.gov More Head Trauma trials

Who can participate

Age range

14 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams Exclusion Criteria: * none

What they're measuring

Head Impact Exposure Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Neurocognitive performance Change from Baseline

Timeframe: Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Self-report Symptom Scores Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)

Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline

Timeframe: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October)