ConcussionPhase 2NCT01978795
Interactive Training in Sports Concussion Prevention and Management
A Phase 2 study testing Brain 101 website in people with Concussion, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Brain 101 website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- didn't meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
Official title: 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.
- Conditions
- Concussion
- Being tested
- Brain 101 website, Control
- Keywords
- concussion, high school, web-based training, school-based health care
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain 101 websiteOther
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Brain 101 website |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in youth athlete and parent knowledge of effective sports concussion management from before and after intervention exposure
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ann Glang, Oregon Center for Applied Science, Inc.
- Investigators
- Ann E Glang, PhD, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978795
- Sponsor's protocol ID
- HD056610
- Other IDs
- R44HD056610
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25438964
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Web-Based Resource in Improving Post-Concussion Management in High Schools
- ClinicalTrials.gov ID
- NCT01978795
- Acronym / sponsor ID
- HD056610
- Conditions
- Concussion
- Keywords
- concussion, high school, web-based training, school-based health care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain 101 website | Experimental | Other: Brain 101 websiteBrain 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. |
| Control | Active comparator | Other: Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- didn't meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain 101 websiteBrain 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). | Other | Brain 101 website |
| ControlAt 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. | Other | Control |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 25438964Glang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann E Glang, PhD principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brain 101 website in people with Concussion, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01978795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.