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The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

30. november 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

103

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • University of North Carolina Injury Prevention Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
Andet: Standard Concussion Education
Participants will receive a standard concussion education module.
Eksperimentel: TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
Andet: TRAIN Concussion Education
Participants will receive the TRAIN concussion education module.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Concussion-Related Beliefs Change Score
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confidence in Concussion-Related Knowledge Change Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

Centers for Disease Control and Prevention

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. maj 2021

Primær færdiggørelse (Faktiske)

15. oktober 2021

Studieafslutning (Faktiske)

30. oktober 2021

Datoer for studieregistrering

Først indsendt

7. april 2021

Først indsendt, der opfyldte QC-kriterier

7. april 2021

Først opslået (Faktiske)

12. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 21-0314

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

9 - 36 months following publication

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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Kliniske forsøg med Hjernerystelse, hjerne

Kliniske forsøg med Standard Concussion Education

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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