- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03142009
Programme d'écoute familiale : mise en œuvre et évaluation multitribales
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mingma L Sherpa, M.S
- Numéro de téléphone: 505-925-1224
- E-mail: mingma@salud.unm.edu
Lieux d'étude
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New Mexico
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Jemez Pueblo, New Mexico, États-Unis, 87024
- Pueblo of Jemez Department of Education
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Mescalero, New Mexico, États-Unis, 88340
- Mescalero Prevention Program
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Pinehill, New Mexico, États-Unis, 87357
- Ramah Navajo School Board
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critères d'inclusion: Les critères d'inclusion incluent toutes les familles de Mescalero Apache, Jemez Pueblo et Ramah Navajo avec un enfant de quatrième et cinquième année et leurs parents ou tuteurs, et grands-parents qui se porteront volontaires pour participer.
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Critères d'exclusion : les personnes inéligibles à cette étude sont : celles qui ne donnent pas leur consentement et/ou leur assentiment pour participer ; ceux qui ne s'identifient pas comme membres tribaux de Mescalero Apache, Jemez Pueblo et Ramah Navajo ou comme membre de la famille d'une personne qui s'identifie comme Mescalero Apache, Jemez Pueblo et Ramah Navajo ; enfants et qui ne sont pas dans la fourchette ciblée de la quatrième et de la cinquième année.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Groupe de programmes
Les membres de l'équipe de recherche tribale recrutent des participants en envoyant des lettres à la maison avec les enfants de quatrième et de cinquième année.
Cette lettre donne un aperçu du FL/CP et invite les parents et les enfants intéressés à en savoir plus.
Les membres de l'équipe TRT et UNM effectuent un suivi individuel avec les parents intéressés.
Si les familles s'engagent à faire partie du FL/CP, une réunion est organisée pour mener le processus de consentement éclairé et effectuer le prétest.
Les familles du groupe programme assistent ensuite aux sessions FL/CP qui couvrent le programme intergénérationnel culturellement adapté.
Les familles du programme participent également à divers aspects du programme, y compris la réalisation d'un projet d'action communautaire.
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Chaque session commence par un dîner collectif où les familles mangent ensemble.
Pratiquez ensuite leurs noms indiens et claniques.
Les séances sont animées par des animateurs dans leur propre langue ou bilingues.
Les animateurs divisent ensuite les familles en groupes d'enfants et d'adultes pour aborder le thème de la séance, puis ils reviennent ensemble à la fin de la séance pour partager leurs apprentissages.
Les séances se terminent toujours avec les enfants et les adultes écrivant dans leurs journaux qui sont des pages individuelles qu'ils placent ensuite dans leurs classeurs.
Les familles reçoivent ensuite leur "pratique à domicile", qui est une tâche que les familles font ensemble pendant la semaine intermédiaire.
Les animateurs récupèrent les cartables du curriculum après chaque séance pour les rapporter aux familles la semaine suivante.
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Aucune intervention: Groupe de comparaison
Dès réception de la lettre, les familles qui ont choisi de ne pas participer ou qui refusent de participer seront invitées à participer à l'étude de recherche en tant que participants de comparaison.
Les participants à la comparaison n'assistent pas aux sessions FL/CP et ne complètent que les tests pré, post et 1 an après.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Abus de substances chez les enfants
Délai: Longitudinal sur 4 ans
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Mesures d'auto-déclaration de la consommation d'alcool, de tabac ou d'autres drogues
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Longitudinal sur 4 ans
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Bien-être de l'enfant
Délai: Longitudinal sur 4 ans
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Mesures d'auto-évaluation de la dépression, de l'anxiété, de l'empathie, de la résolution de problèmes, de la satisfaction de la famille, des activités traditionnelles et de la culture
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Longitudinal sur 4 ans
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Bien-être familial
Délai: Longitudinal sur 4 ans
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Mesures autodéclarées du soutien social, des stratégies d'adaptation, des compétences parentales, des activités traditionnelles et de la culture
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Longitudinal sur 4 ans
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lorenda Belone, PhD, University of New Mexico
- Chercheur principal: Nina Wallerstein, DrPH, University of New Mexico
Publications et liens utiles
Publications générales
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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
- 14-289
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Capital Medical UniversityRecrutement
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Centers for Disease Control and PreventionThe University of Texas Health Science Center, Houston; University of South... et autres collaborateursComplété
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Stuart WillickSports Medicine Research and Testing Laboratory; Partnership for Clean CompetitionComplétéAbus de drogues sportives | Abus de stéroïdes ou d'hormonesÉtats-Unis
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