The TRAIN Study: A Concussion Prevention Strategy in Middle Schools
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina Injury Prevention Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
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Participants will receive a standard concussion education module.
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Experimental: TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
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Participants will receive the TRAIN concussion education module.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concussion-Related Beliefs Change Score
Periodo de tiempo: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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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.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Attitudes Change Score
Periodo de tiempo: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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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.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Confidence in Concussion-Related Knowledge Change Score
Periodo de tiempo: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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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.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Intentions Change Score
Periodo de tiempo: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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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.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Concussion-Related Self-Efficacy Change Score
Periodo de tiempo: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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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.
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Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zachary Kerr, PhD, MPH, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 21-0314
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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