Clinical trial NCT01817049: The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer
Official title: Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Injury
Keywords: prevention
sport injury
soccer
youth
neuromuscular training
intervention
behaviour
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-03-22
Enrollment: 214
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The first wave of 16 teams will be recruited in spring 2013, and will be followed through the 2013 outdoor season, followed by the 2013-2014 indoor season. The second wave of 16 teams will be recruited in fall 2013, and will be followed through the 2013-2014 indoor season, followed by the 2014 outdoor season.

Eligibility criteria: 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.

Primary outcomes:
measure: Team level adherence
timeFrame: duration of two soccer seasons, an expected average of 48 weeks
measure: Individual level adherence
timeFrame: duration of two soccer seasons, an expected average of 48 weeks
Secondary outcomes:
measure: Injury
timeFrame: duration of two soccer seasons, an expected average of 48 weeks
measure: Change in HAPA Questionnaire responses from baseline to end of season 1 and season 2
timeFrame: 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)
Other outcomes:
measure: Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3)
timeFrame: Reliability from baseline to two weeks
Locations:
city: Calgary
country: Canada
facility: Sport Injury Prevention Research Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Carly McKay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Carolyn Emery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steffen K, Meeuwisse WH, Romiti M, Kang J, McKay C, Bizzini M, Dvorak J, Finch C, Myklebust G, Emery CA. Evaluation of how different implementation strategies of an injury prevention programme (FIFA 11+) impact team adherence and injury risk in Canadian female youth football players: a cluster-randomised trial. Br J Sports Med. 2013 May;47(8):480-7. doi: 10.1136/bjsports-2012-091887. Epub 2013 Mar 13.