- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817049
The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer
Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players
Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention. The injury rates in youth soccer where there is no established injury prevention program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation hours. Risk reductions ranging from 32-43% have been found for youth players participating in neuromuscular training programs, such as the FIFA 11+, that include agility, balance training, and strengthening components. Although studies have shown that the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the youth soccer community. It is therefore important to develop ways of delivering the program to soccer coaches and players in order to maximize its protective benefit. The Health Action Process Approach (HAPA) is a behavior change theory that has been used to successfully predict the uptake of health behaviours in a number of populations, such as cancer screening and exercise, but has not been tested in sport injury prevention settings.
The primary objective of this study is to examine the effect of a HAPA-based coach education intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the course of one outdoor and one indoor season. The secondary objective is to examine the dose-response relationship between program adherence and injury, comparing program adherence and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches receive a HAPA-based intervention will have greater adherence to the program than teams whose coaches do not receive the intervention, and that that injury incidence will decrease as adherence to the program increases. It is expected that program adherence will be lower and injury rates will be higher in indoor soccer compared to outdoor soccer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T3H 2E1
- Sport Injury Prevention Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 14 or U-16 female soccer team competing in a Calgary Minor Soccer Association league at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season
- Female youth soccer player (ages 13 to 16 years) participating on a Calgary Minor Soccer Association Club team at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season in a U14 or U16 league
Exclusion Criteria:
- Coach who has used the 11+ with a team he/she has previously coached
- Player with recent (within 6 weeks) history of back or lower extremity injury requiring medical attention or the inability to participate in soccer for at least one day and preventing the player from participating fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season
- Player with a history of systemic disease (e.g. cancer, arthritis, heart disease) or neurological disorder (i.e. head injury, cerebral palsy), preventing the ability to participate fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: HAPA intervention
Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season.
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A 3.5 hour workshop will target HAPA constructs by providing injury risk information (risk perceptions), FIFA 11+ effectiveness evidence (outcome expectancies), and hands-on experience administering the 11+ program to a soccer team (task self-efficacy).
Action planning and coping planning exercises will also be conducted.
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Placebo Comparator: Attention control
Coaches will receive a 3.5 hour workshop prior to the start of the first study season, consisting of innocuous sport nutrition and sport psychology information as an attention control.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Team level adherence
Time Frame: duration of two soccer seasons, an expected average of 48 weeks
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The number of FIFA 11+ exercises completed by the team and the duration of the session will be recorded for each training session and game during the study seasons.
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duration of two soccer seasons, an expected average of 48 weeks
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Individual level adherence
Time Frame: duration of two soccer seasons, an expected average of 48 weeks
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Individual participation in the team training or game session will be recorded, as well as an indication if that player participated in the FIFA 11+ warm up.
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duration of two soccer seasons, an expected average of 48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Injury
Time Frame: duration of two soccer seasons, an expected average of 48 weeks
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An injury sustained during soccer participation will be recorded.
Injury is defined as "any injury occurring during soccer activity resulting in medical attention and/or the removal of the player from the current session and/or subsequent time loss of at least one soccer session (game or practice) as a direct result of that injury."
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duration of two soccer seasons, an expected average of 48 weeks
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Change in HAPA Questionnaire responses from baseline to end of season 1 and season 2
Time Frame: Change from baseline to end of soccer season 1 (expected duration of 24 weeks) and to end of soccer season 2 (expected duration of 48 weeks)
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A questionnaire will be used to assess changes in HAPA constructs (ie: outcome expectancies, risk perceptions, and self-efficacy) between baseline and the end of each playing season (ie: outdoor and indoor).
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Change from baseline to end of soccer season 1 (expected duration of 24 weeks) and to end of soccer season 2 (expected duration of 48 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3)
Time Frame: Reliability from baseline to two weeks
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The SCAT-3 will be provided as a baseline concussion assessment for all study participants.
2-week test-retest reliability of the SCAT-3 will also be assessed.
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Reliability from baseline to two weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carly McKay, PhD, University of Calgary
- Principal Investigator: Carolyn Emery, PhD, University of Calgary
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAIRC&Y-mar2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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