Clinical trial NCT04841473: The TRAIN Study: A Concussion Prevention Strategy in Middle Schools
Official title: Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Keywords: Concussion
Prevention
Management
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-04-12
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Concussion-Related Beliefs Change Score
timeFrame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
measure: Concussion-Related Attitudes Change Score
timeFrame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Secondary outcomes:
measure: Confidence in Concussion-Related Knowledge Change Score
timeFrame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
measure: Concussion-Related Intentions Change Score
timeFrame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
measure: Concussion-Related Self-Efficacy Change Score
timeFrame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Injury Prevention Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Zachary Kerr, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: