Evaluating Huddles As a Novel Approach to Improving Concussion Safety

Seattle Children's Healthcare System

Status: Not yet enrolling

Conditions: Mild Traumatic Brain Injury

Treatments: Behavioral: Pre-Game Safety Huddles

Study type: Interventional

Funder types: Other

Identifiers

NCT06864611

1R01HD114797-01A1

Details and patient eligibility

About

Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.

Full description

The clinical trial portion of this study will enroll 16 youth soccer leagues within four US states. Within each participating league we will enroll two "brackets" (closed units of teams at the same level that compete against each other during the regular season of play) of U12 boys' and girls' U12 teams. Based on typical league and bracket size we anticipate will be 384 teams. Randomization will happen at the league-level. Leagues in the Huddle intervention condition will be supported by US Soccer in implementing Pre-Game Safety Huddles before each regular season game. Leagues in the control condition will continue US Soccer's standard concussion education prevention activities.

Our primary effectiveness and implementation outcomes will be measured at the end of the regular season of play (anticipated to be 10 weeks). Maintenance outcomes will be measured at the end of the regular season of play one year later.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children between the ages of 9 and 13 on eligible teams in participating leagues.
• Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.
• Read and write English

Exclusion criteria

• Cannot read and write English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

US Soccer concussion education as usual.

No Intervention group

Description:

Currently, US Soccer makes web-based concussion education information available, including a video about concussion reporting called "Recognize to Recover."

Pre-Game Safety Huddles

Experimental group

Treatment:

Behavioral: Pre-Game Safety Huddles