The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

NCT04841473 | Completed

• 1 other identifier: 21-0314
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain

Keywords

Concussion; Prevention; Management

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Confidence in Concussion-Related Knowledge Change Score

  Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)

• Concussion-Related Intentions Change Score

  Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)

• Concussion-Related Self-Efficacy Change Score

  Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)

Study Arms (2)

Standard Concussion Education

ACTIVE COMPARATOR

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

Other: Standard Concussion Education

TRAIN Concussion Education

EXPERIMENTAL

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

Other: TRAIN Concussion Education

Interventions

TRAIN Concussion Education OTHER

Participants will receive the TRAIN concussion education module.

TRAIN Concussion Education

Standard Concussion Education OTHER

Participants will receive a standard concussion education module.

Standard Concussion Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of North Carolina Injury Prevention Research Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Zachary Kerr, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: May 17, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 30, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (1)