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

Primary Purpose

Sport Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HAPA-based coach education workshop
placebo attention control
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sport Injury focused on measuring prevention, sport injury, soccer, youth, neuromuscular training, intervention, behaviour

Eligibility Criteria

11 Years - 16 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sport Injury Prevention Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HAPA intervention

Attention control

Arm Description

Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season.

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.

Outcomes

Primary Outcome Measures

Team level adherence
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
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
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
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).

Full Information

First Posted
March 18, 2013
Last Updated
May 28, 2015
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01817049
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport Injury
Keywords
prevention, sport injury, soccer, youth, neuromuscular training, intervention, behaviour

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAPA intervention
Arm Type
Experimental
Arm Description
Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season.
Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HAPA-based coach education workshop
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
placebo attention control
Primary Outcome Measure Information:
Title
Team level adherence
Description
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.
Time Frame
duration of two soccer seasons, an expected average of 48 weeks
Title
Individual level adherence
Description
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.
Time Frame
duration of two soccer seasons, an expected average of 48 weeks
Secondary Outcome Measure Information:
Title
Injury
Description
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."
Time Frame
duration of two soccer seasons, an expected average of 48 weeks
Title
Change in HAPA Questionnaire responses from baseline to end of season 1 and season 2
Description
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).
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)
Other Pre-specified Outcome Measures:
Title
Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3)
Description
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.
Time Frame
Reliability from baseline to two weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly McKay, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Emery, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport Injury Prevention Research Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3H 2E1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23486935
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.
Results Reference
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The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer

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