Concussion, BrainNCT04841473
The TRAIN Study: A Concussion Prevention Strategy in Middle Schools
A study testing TRAIN Concussion Education and Standard Concussion Education in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- TRAIN Concussion Education and Standard Concussion Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adult without a child/children enrolled in a United States middle school
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Injury Prevention Research Center
Chapel Hill, North Carolina, 27514
About this study
Official title: Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
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.
Read the 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.
- Conditions
- Concussion, Brain
- Being tested
- TRAIN Concussion Education, Standard Concussion Education
- Keywords
- Concussion, Prevention, Management
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAIN Concussion EducationOther
Participants will receive the TRAIN concussion education module.
Standard Concussion EducationOther
Participants will receive a standard concussion education module.
| Study group | Role | What they receive |
|---|---|---|
| Standard Concussion Education | Active comparator | Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport. Receives: 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. Receives: Other: TRAIN Concussion Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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.
Measured: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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.
Measured: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start17 May 2021
- Primary completion15 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Zachary Kerr, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841473
- Sponsor's protocol ID
- 21-0314
- Status last verified
- Nov 2021
- First submitted
- 7 Apr 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kerr ZY, Ingram BM, Livingston S, Gildner P, Register-Mihalik JK. An initial assessment of an opinion leader-informed intervention to improve concussion-related outcomes among middle school parents: a randomized controlled trial. Ann Med. 2024 Dec;56(1):2393760. doi: 10.1080/07853890.2024.2393760. Epub 2024 Aug 25.
PubMed 39183448
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
- ClinicalTrials.gov ID
- NCT04841473
- Acronym / sponsor ID
- 21-0314
- Conditions
- Concussion, Brain
- Keywords
- Concussion, Prevention, Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 17 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Concussion Education | Active comparator | Other: Standard Concussion EducationParticipants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport. |
| TRAIN Concussion Education | Experimental | Other: TRAIN Concussion EducationAfter receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Adult without a child/children enrolled in a United States middle school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAIN Concussion EducationParticipants will receive the TRAIN concussion education module. | Other | TRAIN Concussion Education |
| Standard Concussion EducationParticipants will receive a standard concussion education module. | Other | Standard Concussion Education |
Primary outcome
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.
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.
3 secondary outcomes
Confidence in Concussion-Related Knowledge Change Score
Time frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Concussion-Related Intentions Change Score
Time frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Concussion-Related Self-Efficacy Change Score
Time frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Derived from this study: PubMed 39183448Kerr ZY, Ingram BM, Livingston S, Gildner P, Register-Mihalik JK. An initial assessment of an opinion leader-informed intervention to improve concussion-related outcomes among middle school parents: a randomized controlled trial. Ann Med. 2024 Dec;56(1):2393760. doi: 10.1080/07853890.2024.2393760. Epub 2024 Aug 25.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Kerr, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIN Concussion Education and Standard Concussion Education in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion-Related Beliefs Change Score (time frame: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.