NCT01978795

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

October 23, 2013

Last Update Submit

November 6, 2013

Conditions

Keywords

concussionhigh schoolweb-based trainingschool-based health care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Implementation of effective concussion management guidelines

    3 months post intervention

Study Arms (2)

Brain 101 website

EXPERIMENTAL

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.

Other: Brain 101 website

Control

ACTIVE COMPARATOR
Other: Control

Interventions

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).

Brain 101 website
ControlOTHER

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.

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

Related Publications (1)

  • Glang AE, Koester MC, Chesnutt JC, Gioia GA, McAvoy K, Marshall S, Gau JM. The effectiveness of a web-based resource in improving postconcussion management in high schools. J Adolesc Health. 2015 Jan;56(1):91-7. doi: 10.1016/j.jadohealth.2014.08.011. Epub 2014 Oct 29.

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Ann E Glang, PhD

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 8, 2013

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

November 8, 2013

Record last verified: 2013-10

Locations