InjuriesNCT04266925
Preventing Youth Soccer Injury
A study testing 3 referees present and 1 referee present in people with Injuries and Sports Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries, Sports Injury, Sports Injuries in Children
- What is being tested?
- 3 referees present and 1 referee present
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2017to 11 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- unit of measurement was youth soccer teams playing in Birmingham, Alabama area league
Who cannot join
- teams serving children under age 9 or over age 11
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.
- Conditions
- Injuries, Sports Injury, Sports Injuries in Children
- Being tested
- 3 referees present, 1 referee present
- Keywords
- youth soccer injury
- Medical subject headings
- Wounds and Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 referees presentBehavioural
We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
1 referee presentOther
We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
| Study group | Role | What they receive |
|---|---|---|
| 3 referees | Experimental | Three referees were present on the field during these youth soccer matches. Receives: Behavioral: 3 referees present |
| 1 referee | Active comparator | One referee was present on the field during these youth soccer matches. Receives: Other: 1 referee present |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Injuries During Soccer Matches
average number of injury events requiring player to leave the field or be attended by an adult, across all games in study
Measured: baseline through one hour, which is beginning of the game until the end of the game, averaged across games
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start26 Aug 2017
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
- Investigators
- David Schwebel, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266925
- Sponsor's protocol ID
- X160720002
- Status last verified
- May 2020
- First submitted
- 10 Feb 2020
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with qualified experts upon request by email to study PI David Schwebel
Publications
Schwebel DC, Long DL, McClure LA. Injuries on the Youth Soccer (Football) Field: Do Additional Referees Reduce Risk? Randomized Crossover Trial. J Pediatr Psychol. 2020 Aug 1;45(7):759-766. doi: 10.1093/jpepsy/jsaa050.
PubMed 32651582
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Youth Soccer Injury
- ClinicalTrials.gov ID
- NCT04266925
- Acronym / sponsor ID
- X160720002
- Conditions
- Injuries, Sports Injury, Sports Injuries in Children
- Keywords
- youth soccer injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 26 Aug 2017 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 referees | Experimental | Behavioral: 3 referees presentThree referees were present on the field during these youth soccer matches. |
| 1 referee | Active comparator | Other: 1 referee presentOne referee was present on the field during these youth soccer matches. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- unit of measurement was youth soccer teams playing in Birmingham, Alabama area league
Key exclusion criteria (1 listed)
- teams serving children under age 9 or over age 11
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 |
|---|---|---|
| 3 referees presentWe compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks. | Behavioural | 3 referees |
| 1 referee presentWe compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks. | Other | 1 referee |
Primary outcome
Average Number of Injuries During Soccer Matches
Time frame: baseline through one hour, which is beginning of the game until the end of the game, averaged across games
average number of injury events requiring player to leave the field or be attended by an adult, across all games in study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32651582Schwebel DC, Long DL, McClure LA. Injuries on the Youth Soccer (Football) Field: Do Additional Referees Reduce Risk? Randomized Crossover Trial. J Pediatr Psychol. 2020 Aug 1;45(7):759-766. doi: 10.1093/jpepsy/jsaa050.
- Individual participant dataSharing planned: No. Data will be shared with qualified experts upon request by email to study PI David Schwebel
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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. This study is not recruiting at the moment.
David Schwebel, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 referees present and 1 referee present in people with Injuries and Sports Injury, run by University of Alabama at Birmingham at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Number of Injuries During Soccer Matches (time frame: baseline through one hour, which is beginning of the game until the end of the game, averaged across games). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266925, which also lists 1 linked publication.
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 May 2020.