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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01978795
Other study ID # HD056610
Secondary ID R44HD056610
Status Completed
Phase Phase 2
First received October 23, 2013
Last updated November 6, 2013
Start date August 2011
Est. completion date February 2012

Study information

Verified date October 2013
Source Oregon Center for Applied Science, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 2012
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
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. 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).
Control
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.

Locations

Country Name City State
United States Oregon Center for Applied Science Eugene Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Center for Applied Science, Inc. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Implementation of effective concussion management guidelines 3 months post intervention No
Primary Change in youth athlete and parent knowledge of effective sports concussion management from before and after intervention exposure 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 No
Secondary Change in youth athlete and parent ratings of self-efficacy in sports concussion management 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 No
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