Mild Traumatic Brain InjuryNCT06864611
Evaluating Huddles as a Novel Approach to Improving Concussion Safety
A study testing Pre-Game Safety Huddles in people with Mild Traumatic Brain Injury, run by Seattle Children's Hospital.
Trial summary
Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Pre-Game Safety Huddles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cannot read and write English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.
Read the detailed 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Pre-Game Safety Huddles
- Keywords
- concussion, brain injury, prevention
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Game Safety HuddlesBehavioural
Before every regular season game, participating teams in league randomized to the Pre-Game Safety Huddle condition will hold brief Pre-Game Safety Huddles. Pre-Game Safety Huddles have three core components: (1) Gather (Athletes, coaches, officials, and other stakeholders come together before the start of the game); (2) Share (Opinion leaders (coaches, referees) affirm the importance of seeking care for suspected concussion, and (3) Repeat (Process is repeated before every game)
| Study group | Role | What they receive |
|---|---|---|
| US Soccer concussion education as usual. | No intervention | 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 | Not described Receives: Behavioral: Pre-Game Safety Huddles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected concussion reporting behavior (Concussion Reporting- Expectations scale)
Concussion Reporting- Expectations (CR-E), a 4-item scale that assesses athlete's expectations that they would tell a coach or other trusted adult about post-impact concussive symptoms in naturalistic scenarios. Responses are measured on a 4-point Likert scale, with higher sores indicating a stronger expectation that they would report future post-impact concussive symptoms.
Measured: Baseline, 10 weeks (end of regular competitive season)
Identification of suspected concussions
Identification of suspected concussions will be measured via coach report as the number of times per season an athlete was identified as having a possible concussion (from 1- athlete-report to a coach, medical personnel or parent report to a coach, or 2- athlete removal from play for suspected concussive symptoms without report, for example due to loss of consciousness). This will be expressed as a team-level rate (number of instances/number of athletes per team).
Measured: Baseline, 10 weeks (end of regular competitive season)
Secondary outcomes (3)
Perceived concussion reporting norms - Athlete (CR-N)
CR-N is a 4-item scale that assesses the coach's perception that coaches in their organization would want athletes to report suspected concussive symptoms. Responses to four scenarios are measured on a 4-point Likert scale, with higher sores indicating a stronger perceived norms in support of reporting future post-impact concussive symptoms.
Measured: Baseline, 10 weeks (end of regular competitive season)
Perceived concussion reporting norms - Coach (CR-N)
CR-N is a 4-item scale that assesses the coach's perception that coaches in their organization would want athletes to report suspected concussive symptoms. Responses to four scenarios are measured on a 4-point Likert scale, with higher sores indicating a stronger perceived norms in support of reporting future post-impact concussive symptoms.
Measured: Baseline, 10 weeks (end of regular competitive season)
Huddle implementation
Administrative data will be used to record the number of games before which Huddles occurred, which will be expressed as a rate with a denominator of Huddle-eligible games.
Measured: 10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kroshus, Seattle Children's Hospital
- Investigators
- Emily Kroshus, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864611
- Sponsor's protocol ID
- 1R01HD114797-01A1
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Huddles as a Novel Approach to Improving Concussion Safety
- ClinicalTrials.gov ID
- NCT06864611
- Acronym / sponsor ID
- 1R01HD114797-01A1
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- concussion, brain injury, prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US Soccer concussion education as usual. | No intervention | –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 | Behavioral: Pre-Game Safety Huddles |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Cannot read and write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Game Safety HuddlesBefore every regular season game, participating teams in league randomized to the Pre-Game Safety Huddle condition will hold brief Pre-Game Safety Huddles. Pre-Game Safety Huddles have three core components: (1) Gather (Athletes, coaches, officials, and other stakeholders come together before the start of the game); (2) Share (Opinion leaders (coaches, referees) affirm the importance of seeking care for suspected concussion, and (3) Repeat (Process is repeated before every game) | Behavioural | Pre-Game Safety Huddles |
Primary outcome
Expected concussion reporting behavior (Concussion Reporting- Expectations scale)
Time frame: Baseline, 10 weeks (end of regular competitive season)
Concussion Reporting- Expectations (CR-E), a 4-item scale that assesses athlete's expectations that they would tell a coach or other trusted adult about post-impact concussive symptoms in naturalistic scenarios. Responses are measured on a 4-point Likert scale, with higher sores indicating a stronger expectation that they would report future post-impact concussive symptoms.
Identification of suspected concussions
Time frame: Baseline, 10 weeks (end of regular competitive season)
Identification of suspected concussions will be measured via coach report as the number of times per season an athlete was identified as having a possible concussion (from 1- athlete-report to a coach, medical personnel or parent report to a coach, or 2- athlete removal from play for suspected concussive symptoms without report, for example due to loss of consciousness). This will be expressed as a team-level rate (number of instances/number of athletes per team).
3 secondary outcomes
Perceived concussion reporting norms - Athlete (CR-N)
Time frame: Baseline, 10 weeks (end of regular competitive season)
Perceived concussion reporting norms - Coach (CR-N)
Time frame: Baseline, 10 weeks (end of regular competitive season)
Huddle implementation
Time frame: 10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Kroshus principal investigator
Seattle Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Game Safety Huddles in people with Mild Traumatic Brain Injury, run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Kroshus (206-884-5326, emily.kroshus@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expected concussion reporting behavior (Concussion Reporting- Expectations scale) (time frame: Baseline, 10 weeks (end of regular competitive season)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.