The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

University of North Carolina (UNC)

Status: Completed

Conditions: Concussion, Brain

Treatments: Other: TRAIN Concussion Education; Other: Standard Concussion Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04841473

21-0314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Standard Concussion Education

Active Comparator group

Description:

Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.

Treatment:

Other: Standard Concussion Education

TRAIN Concussion Education

Experimental group

Description:

After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.

Treatment:

Other: TRAIN Concussion Education