search
Back to results

Comparison of Concussion Education Programs

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Brain

Eligibility Criteria

14 Years - 19 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion:

  • Athletes from three high school football teams in California.
  • In attendance for practice on both study dates
  • Provided signed assent and parental consent.

Exclusion:

  • Did not complete more than 50% of the questionnaire.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Crashcourse

CDC Video

CDC Written

Arm Description

CC uses an approach to providing concussion education informed by user-centered formative design research studies. The program features an interactive "choose your own adventure" approach to navigate the learner through the content, and is guided by near-peer Division I collegiate football athletes

CDC-Vi is an online learning module developed by the CDC and the National Federation of State High School Associations Learning Center. Learners progress through the curriculum sequentially completing each unit before proceeding to the next. The primary narrator of CDC-Vi is Dr. Mick Koester, Chair of the NFHS Sports Medicine Advisory Committee

CDC-Wr consists of educational PDFs available for download from the CDC website, as part of the CDC's "Heads Up" brain injury awareness initiative. The PDFs used for the CDC-Wr condition were specific to high school athlete concussion education

Outcomes

Primary Outcome Measures

Improvement in concussion reporting intention among athletes
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on the inverse of athlete responses to five questions about their concussion-reporting intention (i.e., whether they would continue playing with a concussion during "the beginning of the season," "a practice," "the middle of the season," "during a championship game," and "at the end of the season").

Secondary Outcome Measures

Improvement in concussion knowledge among athletes
Athletes answered 23 True/False questions to assess their concussion knowledge modified from previously utilized concussion educational assessments (Rosenbaum et al., 2010). A composite measure of athlete concussion knowledge was created by summing athletes' correct responses and dividing by the number of questions asked. Rosenbaum AM, Arnett PA. The development of a survey to examine knowledge about and attitudes toward concussion in high-school students. J Clin Exp Neuropsychol. 2010;32(1):44-55. doi:10.1080/13803390902806535
Improvement in concussion attitudes among athletes
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to six questions about their attitudes towards concussion reporting (i.e., the extent to which an athlete who reports a concussion would be "better off in the long run," "back on the field much faster," "proud even if teammates call me weak," "better off avoiding participation with signs and symptoms of a concussion," not "better off hiding symptoms from a doctor to not stay out as long," and not "better off toughing it out because concussions are just another injury").
Improvement in concussion perceived normative beliefs among athletes
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to two questions assessing perceived reporting norms (i.e., the extent to which the athlete worried "my teammates would think less of me" if he reported a concussion, or needed to "hide my symptoms from my coach").
Improvement in concussion perceived behavioral control among athletes
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to six questions about their perceived ability and confidence with concussion reporting (i.e., confidence in my ability "to report a concussion," "to help my teammate report a concussion," "to report symptoms of a concussion," "to help my teammate report symptoms of a concussion," "to report symptoms of a concussion, even if I don't think they're that bad," and "to help my teammate report symptoms of a concussion, even if I don't think they're that bad").

Full Information

First Posted
July 23, 2020
Last Updated
July 27, 2020
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT04492696
Brief Title
Comparison of Concussion Education Programs
Official Title
Comparison of Concussion Education Programs and Intent to Report Concussion in High School Football Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. Athletes' report of concussion symptoms is therefore an important component of risk reduction. Numerous educational interventions to improve concussion knowledge and reporting exist. Objective: Evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention. Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment before, immediately after, and one-month after educational intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crashcourse
Arm Type
Active Comparator
Arm Description
CC uses an approach to providing concussion education informed by user-centered formative design research studies. The program features an interactive "choose your own adventure" approach to navigate the learner through the content, and is guided by near-peer Division I collegiate football athletes
Arm Title
CDC Video
Arm Type
Active Comparator
Arm Description
CDC-Vi is an online learning module developed by the CDC and the National Federation of State High School Associations Learning Center. Learners progress through the curriculum sequentially completing each unit before proceeding to the next. The primary narrator of CDC-Vi is Dr. Mick Koester, Chair of the NFHS Sports Medicine Advisory Committee
Arm Title
CDC Written
Arm Type
Active Comparator
Arm Description
CDC-Wr consists of educational PDFs available for download from the CDC website, as part of the CDC's "Heads Up" brain injury awareness initiative. The PDFs used for the CDC-Wr condition were specific to high school athlete concussion education
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education
Primary Outcome Measure Information:
Title
Improvement in concussion reporting intention among athletes
Description
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on the inverse of athlete responses to five questions about their concussion-reporting intention (i.e., whether they would continue playing with a concussion during "the beginning of the season," "a practice," "the middle of the season," "during a championship game," and "at the end of the season").
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Improvement in concussion knowledge among athletes
Description
Athletes answered 23 True/False questions to assess their concussion knowledge modified from previously utilized concussion educational assessments (Rosenbaum et al., 2010). A composite measure of athlete concussion knowledge was created by summing athletes' correct responses and dividing by the number of questions asked. Rosenbaum AM, Arnett PA. The development of a survey to examine knowledge about and attitudes toward concussion in high-school students. J Clin Exp Neuropsychol. 2010;32(1):44-55. doi:10.1080/13803390902806535
Time Frame
1 month
Title
Improvement in concussion attitudes among athletes
Description
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to six questions about their attitudes towards concussion reporting (i.e., the extent to which an athlete who reports a concussion would be "better off in the long run," "back on the field much faster," "proud even if teammates call me weak," "better off avoiding participation with signs and symptoms of a concussion," not "better off hiding symptoms from a doctor to not stay out as long," and not "better off toughing it out because concussions are just another injury").
Time Frame
1 month
Title
Improvement in concussion perceived normative beliefs among athletes
Description
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to two questions assessing perceived reporting norms (i.e., the extent to which the athlete worried "my teammates would think less of me" if he reported a concussion, or needed to "hide my symptoms from my coach").
Time Frame
1 month
Title
Improvement in concussion perceived behavioral control among athletes
Description
All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on athlete responses to six questions about their perceived ability and confidence with concussion reporting (i.e., confidence in my ability "to report a concussion," "to help my teammate report a concussion," "to report symptoms of a concussion," "to help my teammate report symptoms of a concussion," "to report symptoms of a concussion, even if I don't think they're that bad," and "to help my teammate report symptoms of a concussion, even if I don't think they're that bad").
Time Frame
1 month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
American football players
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: Athletes from three high school football teams in California. In attendance for practice on both study dates Provided signed assent and parental consent. Exclusion: Did not complete more than 50% of the questionnaire.
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Via contact with study PI, and pending approval of IRB

Learn more about this trial

Comparison of Concussion Education Programs

We'll reach out to this number within 24 hrs