Clinical trial NCT05768217: Community Resiliency Collective Efficacy Intervention
Official title: Community Resiliency Collective Efficacy Intervention (CRCEI) for Prevention of Community Violence - A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence, Physical
Violence, Non-accidental
Violence, Sexual
Violence, Domestic
Violence, Structural
Violence in Adolescence
Community Violence
Social Cohesion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-03-14
Enrollment: 4600
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This 2-armed cluster-randomized-controlled community-partnered project will examine the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence, Community Resiliency Collective Efficacy Intervention (CRCEI). The comparison intervention will be health education sessions, which will occur monthly as a 'light touch' intervention in control neighborhoods to recruit a similar number of community members as in the intervention neighborhoods. The study will be located in Allegheny County in Pennsylvania across 20 neighborhoods (i.e., clusters), such that assigned intervention neighborhoods (n=4) will be matched to similar comparison neighborhoods (n=4), and 12 neighborhoods will be randomized either to receive the Collective Efficacy program (i.e., intervention neighborhood, n=6) or to health sessions (comparison neighborhood, n=6). Community surveys will examine neighborhood perspectives before and after program implementation.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in perceptions of neighborhood collective efficacy and community cohesion
timeFrame: Change from baseline to approximately 12 months after baseline
Secondary outcomes:
measure: Community incidence of violence in 12 month period
timeFrame: Change from 1 year period before baseline to approximately 12 months after baseline
measure: Community incidence of violence in 12 month period
timeFrame: Change from 1 year period before baseline to approximately 2 years after baseline
measure: Change from baseline in collective efficacy and neighborhood social norms
timeFrame: Change from baseline to approximately 12 months after baseline
measure: Number of self-reported events of violence exposure
timeFrame: Change from baseline to approximately 12 months after baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: