The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Calgary
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Carly McKay, University of Calgary
ClinicalTrials.gov Identifier:
NCT01817049
First received: March 18, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Sport Injury
Behavioral: HAPA-based coach education workshop
Behavioral: placebo attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Team level adherence [ Time Frame: duration of two soccer seasons, an expected average of 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Individual level adherence [ Time Frame: duration of two soccer seasons, an expected average of 48 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Injury [ Time Frame: duration of two soccer seasons, an expected average of 48 weeks ] [ Designated as safety issue: Yes ]
    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."

  • 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) ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3) [ Time Frame: Reliability from baseline to two weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 450
Study Start Date: March 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAPA intervention
Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season.
Behavioral: HAPA-based coach education workshop
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.
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.
Behavioral: placebo attention control

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

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817049

Contacts
Contact: Carly McKay, PhD 403-220-6095 cdmckay@ucalgary.ca

Locations
Canada, Alberta
Sport Injury Prevention Research Centre Recruiting
Calgary, Alberta, Canada, T3H 2E1
Contact: Carly McKay, PhD    403-220-6095    cdmckay@ucalgary.ca   
Principal Investigator: Carly McKay, PhD         
Principal Investigator: Carolyn Emery, PhD         
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Carly McKay, PhD University of Calgary
Principal Investigator: Carolyn Emery, PhD University of Calgary
  More Information

Publications:
Responsible Party: Carly McKay, Post Doctoral Fellow, University of Calgary
ClinicalTrials.gov Identifier: NCT01817049     History of Changes
Other Study ID Numbers: STAIRC&Y-mar2013
Study First Received: March 18, 2013
Last Updated: March 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
prevention
sport injury
soccer
youth
neuromuscular training
intervention
behaviour

Additional relevant MeSH terms:
Athletic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014