- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978795
Interactive Training in Sports Concussion Prevention and Management
November 6, 2013 updated by: Ann Glang, Oregon Center for Applied Science, Inc.
The Effectiveness of a Web-Based Resource in Improving Post-Concussion Management in High Schools
This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools.
The study hypotheses were that athletes and parents who viewed the Brain 101 program would demonstrate increased knowledge and self efficacy in concussion management, and that use of the intervention would positively affect school concussion management practices.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Center for Applied Science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for participating schools:
- athletic trainer (AT) on staff or contracted by school for services
- school access to a high-speed internet connection
- agreement to expose all students participating in fall sports to the training.
Exclusion Criteria:
- didn't meet inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
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At control schools, parents viewed Centers for Disease Control materials on safe teen drivers.
Athletes viewed web-based materials about teens staying safe on the job.
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Experimental: Brain 101 website
Brain 101: The Concussion Play book is a web-based, stand-alone guide for school leaders on effective policies and practices in concussion management.
The website offers a school-wide approach to preventing and managing sports concussion, including a) training for educators, athletics staff, students, and parents; b) guidelines for creating a concussion management team; and c) information on strategies for supporting students in the classroom following concussion.
|
Brain 101: The Concussion Play book is a web-based, stand-alone guide for school leaders on effective policies and practices in concussion management.
Consistent with the literature on effective school-based change efforts, the website offers a comprehensive, school-wide approach to preventing and managing sports concussion, including training for educators, athletics staff, students, and parents.
The website presents guidelines for creating a concussion management team (CMT) that meets regularly to support students as they return to academics, extra-curricular activities, and athletics.
It also includes information on strategies for supporting students in the classroom following concussion (e.g., designing reduced school schedules, monitoring school performance following concussion).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in youth athlete and parent knowledge of effective sports concussion management from before and after intervention exposure
Time Frame: Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention
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Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in youth athlete and parent ratings of self-efficacy in sports concussion management
Time Frame: Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention
|
Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implementation of effective concussion management guidelines
Time Frame: 3 months post intervention
|
3 months post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ann E Glang, PhD, Oregon Center for Applied Science
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Estimate)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 6, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- HD056610
- R44HD056610 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Concussion
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Sync-Think, Inc.CompletedBrain Injuries | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion; Eye | Concussion, CerebralUnited States
-
BrainScope Company, Inc.CompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
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BrainScope Company, Inc.United States Department of DefenseCompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
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BrainScope Company, Inc.CompletedBrain Injuries, Traumatic | Concussion, Mild | Concussion, Brain | Concussion, Severe | Concussion, IntermediateUnited States
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Spaulding Rehabilitation HospitalTerminated
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Panam ClinicCompleted
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University of PennsylvaniaUniversity of Oklahoma; Carnegie Mellon UniversityWithdrawnConcussion
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University Hospital, ToulouseTerminated
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Thomas Jefferson UniversityRothman Institute OrthopaedicsTerminated
-
University of PittsburghWithdrawnConcussionUnited States
Clinical Trials on Brain 101 website
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NYU Langone HealthCompleted
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Odense University HospitalCompletedHealth Knowledge, Attitudes, Practice | Downs SyndromeDenmark
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Universitätsklinikum Hamburg-EppendorfSanofiCompletedMultiple Sclerosis | Clinically Isolated Syndrome | Multiple Sclerosis, Relapsing-RemittingGermany
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