The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

Concussion, Brain Clinical Trial

Official title:

Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841473
• Other study ID #: 21-0314
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 30, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Other:
• TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.
• Standard Concussion Education
Participants will receive a standard concussion education module.

Locations

Country	Name	City	State
United States	University of North Carolina Injury Prevention Research Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concussion-Related Beliefs Change Score	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.	Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Primary	Concussion-Related Attitudes Change Score	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.	Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Secondary	Confidence in Concussion-Related Knowledge Change Score	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.	Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Secondary	Concussion-Related Intentions Change Score	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.	Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Secondary	Concussion-Related Self-Efficacy Change Score	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.	Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)