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The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04841473
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:

Purpose: The purpose of this study is to evaluate the effectiveness of a theory-driven intervention (TRAIN concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy.

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.


Condition or disease Intervention/treatment Phase
Concussion, Brain Other: TRAIN Concussion Education Other: Standard Concussion Education Not Applicable

Detailed Description:

A convenience sample of participants will be recruited from parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years. Interested parents will contact study stuff, who will ensure eligibility criteria are met.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
Actual Study Start Date : May 17, 2021
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
 Other: Standard Concussion Education
Participants will receive a standard concussion education module.
Experimental: TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
 Other: TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.


Outcome Measures
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Primary Outcome Measures :
  1. Concussion-Related Beliefs Change Score [ Time Frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion) ]
    Participants are asked 6 questions concerning beliefs related to concussion risk, symptoms, and management. These items are added together to compute an overall score. Scoring scale ranges from a minimum of 6 to a maximum 24, where a higher score indicated more favorable beliefs. A change score will be computed post score-pre score.

  2. Concussion-Related Attitudes Change Score [ Time Frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion) ]
    Participants are asked 20 survey items identifying an individual's attitudes about a certain behavior (e.g., seeking care). Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 20 to a maximum of 140, where higher scores indicate more favorable attitudes. A change score will be computed post score-pre score.


Secondary Outcome Measures :
  1. Confidence in Concussion-Related Knowledge Change Score [ Time Frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion) ]
    Participants are asked 2 questions concerning confidence in knowing and recognizing concussion symptoms. These items are added together to compute an overall score. Scoring scale ranges from a minimum of 2 to a maximum 8, where a higher score indicated better confidence in concussion knowledge. A change score will be computed post score-pre score.

  2. Concussion-Related Intentions Change Score [ Time Frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion) ]
    Participants are asked 4 questions assessing intention to engage in or talk with others about concussion prevention. The items are totaled to compute an overall behavioral intention score. Scoring scale ranges from a minimum of 4 to a maximum of 16, where a higher score indicates a better likelihood to engage in favorable behaviors related to concussion prevention. A change score will be computed post score-pre score.

  3. Concussion-Related Self-Efficacy Change Score [ Time Frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion) ]
    Participants are asked 8 questions assessing their self-efficacy regarding engaging in or talking with others about concussion prevention. The items are totaled to compute an overall self-efficacy score. Scoring scale ranges from a minimum of 8 to a maximum of 32, where a higher score indicates higher self-efficacy. A change score will be computed post score-pre score.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult with a child/children enrolled in a United States middle school
  • Adult whose child has participated in organized sports in the past 2 years

Exclusion Criteria:

• Adult without a child/children enrolled in a United States middle school

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841473


Locations
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United States, North Carolina
University of North Carolina Injury Prevention Research Center
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Zachary Kerr, PhD, MPH University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Informed Consent Form  [PDF] September 7, 2021

More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04841473    
Other Study ID Numbers: 21-0314
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 9 - 36 months following publication
Access Criteria: IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Concussion
Prevention
Management
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating