- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04841473
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
North Carolina
-
Chapel Hill, North Carolina, États-Unis, 27514
- University of North Carolina Injury Prevention Research Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Standard Concussion Education
Participants will receive standard concussion education materials (online training) focused on concussion prevention in youth sport.
|
Participants will receive a standard concussion education module.
|
Expérimental: TRAIN Concussion Education
After receiving the standard concussion education materials (online training), participants will receive an additional module, the TRAIN concussion education module.
|
Participants will receive the TRAIN concussion education module.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Concussion-Related Beliefs Change Score
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Confidence in Concussion-Related Knowledge Change Score
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Zachary Kerr, PhD, MPH, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21-0314
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Commotion cérébrale, cerveau
-
Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne
Essais cliniques sur Standard Concussion Education
-
Universidad San SebastiánUniversidad de Valparaiso; Fondo de Fomento al Desarrollo Científico y Tecnológico...RecrutementGain de poids gestationnel | Obésité maternelleChili
-
Oregon Research InstituteComplétéTrouble lié à l'utilisation de substances | DélinquanceÉtats-Unis
-
University of PennsylvaniaRestaurant AssociatesActif, ne recrute pasObésité | Gain de poids | Préférences alimentaires | Sélection de nourritureÉtats-Unis
-
University of MichiganInscription sur invitationLa dépression | Anxiété | Trouble du sommeil | DépendanceÉtats-Unis
-
Institute of Cardiology, Warsaw, PolandInconnueRéadaptation cardiaquePologne
-
Lievensberg ZiekenhuisInconnueObésité morbide | Pontage gastrique | Chirurgie bariatriquePays-Bas
-
Shanghai Zhongshan HospitalInconnueTumeurs | Lymphome | Inflammation | Cancer | Infection | Sarcoïde | Lésion de masseChine
-
University Hospital, BordeauxInstitut National de la Santé Et de la Recherche Médicale, France; Université... et autres collaborateursComplétéLa maladie d'AlzheimerFrance
-
Jiangsu HengRui Medicine Co., Ltd.Actif, ne recrute pasAnémie aplasique sévèreChine
-
Swiss Group for Clinical Cancer ResearchRésiliéCancer colorectal métastatiqueSuisse, L'Autriche