- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05768217
Intervention sur l'efficacité collective de la résilience communautaire
Intervention d'efficacité collective de résilience communautaire (CRCEI) pour la prévention de la violence communautaire - Un essai contrôlé randomisé en grappes
This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of an innovative community-centered intervention that promotes thriving and resiliency to reduce community violence. In collaboration with community partners, this study will implement a Community Resiliency Collective Efficacy Intervention (CRCEI) to engage community members in dialogue on neighborhood transformation, racial and gender equity, community leadership, and organizing for social change. Facilitating discussion and community organizing within neighborhoods about child and youth thriving is expected to increase individual and neighborhood levels of collective efficacy and reduce community violence. Using a community-partnered participatory approach, this study will use a Community Thriving Matrix tool to engage youth and adult community members in ongoing dialogue on neighborhood transformation, community leadership, and organizing for social change. This focus on envisioning and creating neighborhoods in which children and adolescents can thrive is expected to translate to increased individual and neighborhood levels of collective efficacy as well as violence reduction. Comparison neighborhoods will receive health education sessions as a control intervention. The proposed study involves diverse neighborhoods in the Pittsburgh region and collecting survey data from youth (ages 13-19 years) and adult community participants (both male and female identified). Interviews with a sub-sample of community residents and facilitators and community site leads as well as observations of intervention delivery will provide qualitative information on processes of program implementation. This study will provide the first rigorous evaluation of this community-level prevention approach.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- youth age 13 years old and up (all genders)
- adults 18 years and older (all genders)
- reside in neighborhoods selected to participate in the study
Exclusion Criteria:
-
individuals younger than 13 years old
- individuals residing outside of participating neighborhoods
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Community Resiliency Collective Efficacy Intervention (CRCEI)
Community Resiliency Collective Efficacy Intervention (CRCEI) to engage community members in dialogue on thriving, community leadership, and organizing for social change (9 sessions). |
The Community Resiliency Collective Efficacy Intervention (CRCEI) will involve community members in dialogue on thriving, community leadership, and organizing for social change. Participants in the intervention condition will be asked to participate in 2 sessions of discussions about community thriving and a 7-week training program on the following topics: Building on the Strengths of Your Community, Collective Efficacy and its Effects on Violence Prevention & Community Mental Health, Non-threatening Peaceful Intervention Principles and Strategies: Part One, Non-threatening Peaceful Intervention Principles and Strategies: Part Two, Safety and Roles of Police and Community in Intervening, Active/Effective listening and non-violent communication skills, and Community Resources and Indirect Intervention. |
|
Comparateur actif: Health Education Sessions
Comparison neighborhoods will receive health education sessions as a control intervention. (9 sessions) |
Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline in perceptions of neighborhood collective efficacy and community cohesion
Délai: Change from baseline to approximately 12 months after baseline
|
Composite Measure mean score (range 1 - 5; 1 is low and 5 is best) of neighborhood-level perceptions of collective efficacy and community cohesion |
Change from baseline to approximately 12 months after baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Community incidence of violence in 12 month period
Délai: Change from 1 year period before baseline to approximately 12 months after baseline
|
number of incidents of violence, i.e., assaults, gun violence, referrals to child protective services, compared to control neighborhoods. |
Change from 1 year period before baseline to approximately 12 months after baseline
|
|
Community incidence of violence in 12 month period
Délai: Change from 1 year period before baseline to approximately 2 years after baseline
|
number of incidents of violence, i.e., assaults, gun violence, referrals to child protective services, compared to control neighborhoods. |
Change from 1 year period before baseline to approximately 2 years after baseline
|
|
Change from baseline in collective efficacy and neighborhood social norms
Délai: Change from baseline to approximately 12 months after baseline
|
Composite Collective Efficacy Measure mean score (range 1-5; 1 is lowest and 5 is best) of individual-level collective efficacy and neighborhood social norms |
Change from baseline to approximately 12 months after baseline
|
|
Number of self-reported events of violence exposure
Délai: Change from baseline to approximately 12 months after baseline
|
count of individual-level events of violence exposure |
Change from baseline to approximately 12 months after baseline
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alison Culyba, MD, PhD, MPH, University of Pittsburgh
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY22100193
- U01CE003524-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
We do not plan to make a fully documented, publicly available data set on a website for download because while individual participant data are de-identified, it could be possible to discern the neighborhoods or sites from the dataset and therefore compromise the anonymity of the data. Therefore, we will make the data available only to selected researchers who apply for access. The application must document a legitimate public health use or research question for the data, and the applicant must sign a pledge to keep all data private and to make no attempt to identify individual subjects. This use of the data is consistent with the planned language of the voluntary consent for participation agreed and in accordance with IRB policy.
Délai de partage IPD
12 months after data collection is completed.
Critères d'accès au partage IPD
Data sharing agreement must be completed with investigators and the University of Pittsburgh.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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