The TRAIN Study: A Concussion Prevention Strategy in Middle Schools
NCT ID: NCT04841473
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2021-05-17
2021-10-30
Brief Summary
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Participants: 180 parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years.
Procedures: The study is a single-blind (participants) randomized control trial. The investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education AND TRAIN concussion education) to evaluate the effectiveness of the TRAIN concussion education intervention.
Detailed Description
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Upon this, and completing the written informed consent process, participants will be assigned a unique identifier and randomized (simple) without replacement to one of the two study arms (control vs. treatment), using a predetermined random number generator in Excel.
Participants in the control group will receive standard concussion education materials focused on concussion prevention in youth sport. Participants in the treatment group will receive the same standard concussion education materials AND the TRAIN concussion education module. The TRAIN education module is grounded in a theoretical structure inclusive of the original intervention tenants of the Popular Opinion Leader (POL) and Diffusion of Innovations frameworks, and within the context of the socioecological model.
Participants will complete a self-administered online pre-test survey, which includes assessments of concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. After completion of the pre-test survey, participants will complete their assigned intervention (TRAIN concussion education module + standard concussion education materials versus standard concussion education materials only).
Upon completion of their assigned intervention, participants will complete the online survey again to obtain post-test measures (post-test survey). Participants will also be scheduled to complete individual semi-structured interviews.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
Standard Concussion Education
Participants will receive a standard concussion education module.
TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.
Interventions
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TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.
Standard Concussion Education
Participants will receive a standard concussion education module.
Eligibility Criteria
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Inclusion Criteria
* Adult whose child has participated in organized sports in the past 2 years
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Zachary Kerr, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina Injury Prevention Research Center
Chapel Hill, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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21-0314
Identifier Type: -
Identifier Source: org_study_id