NCT04020874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3.3 years

First QC Date

July 1, 2019

Last Update Submit

December 1, 2023

Conditions

Keywords

concussiontackleyouth sports

Outcome Measures

Primary Outcomes (5)

  • Head Impact Exposure Change from Baseline

    The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)

    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

    Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)

    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

    Concussion symptom scores (0-6 Likert scale; 0=none, 1=mild, 6=severe) for 22 symptoms as measured by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT). Scores are totaled.

    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

    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.

    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

    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.

    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)

Secondary Outcomes (1)

  • Intervention frequency (ie. dose response)

    During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)

Study Arms (3)

Baseline

NO INTERVENTION

Year 1, no intervention to generate baseline, comparative data for subsequent years

HuTT-2x

EXPERIMENTAL

The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 2 times each week throughout the regular season.

Behavioral: HuTT-2x

HuTT-4x

EXPERIMENTAL

The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 4 times each week throughout the regular season.

Behavioral: HuTT-4x

Interventions

HuTT-2xBEHAVIORAL

tackling and blocking training twice/week

HuTT-2x
HuTT-4xBEHAVIORAL

tackling and blocking training four times/week

HuTT-4x

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii at Manoa

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaBrain Concussion

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Erik Swartz

    University of Massachussetts Lowell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
statistician
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: pre-test, post-test, quasi-experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Chair

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 16, 2019

Study Start

July 22, 2019

Primary Completion

October 29, 2022

Study Completion

January 25, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

individual participant data (IPD) will not be made available to other researchers

Locations