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The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

30 november 2021 bijgewerkt door: University of North Carolina, Chapel Hill

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

103

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • University of North Carolina Injury Prevention Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
Ander: Standard Concussion Education
Participants will receive a standard concussion education module.
Experimenteel: TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
Ander: TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concussion-Related Beliefs Change Score
Tijdsspanne: 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.
Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Concussion-Related Attitudes Change Score
Tijdsspanne: 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.
Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Confidence in Concussion-Related Knowledge Change Score
Tijdsspanne: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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)
Concussion-Related Intentions Change Score
Tijdsspanne: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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)
Concussion-Related Self-Efficacy Change Score
Tijdsspanne: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of North Carolina, Chapel Hill

Medewerkers

Centers for Disease Control and Prevention

Onderzoekers

  • Hoofdonderzoeker: Zachary Kerr, PhD, MPH, University of North Carolina, Chapel Hill

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 mei 2021

Primaire voltooiing (Werkelijk)

15 oktober 2021

Studie voltooiing (Werkelijk)

30 oktober 2021

Studieregistratiedata

Eerst ingediend

7 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

7 april 2021

Eerst geplaatst (Werkelijk)

12 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 december 2021

Laatste update ingediend die voldeed aan QC-criteria

30 november 2021

Laatst geverifieerd

1 november 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 21-0314

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

9 - 36 months following publication

IPD-toegangscriteria voor delen

IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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