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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768217
Other study ID # STUDY22100193
Secondary ID U01CE003524-01
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2024
Est. completion date September 30, 2027

Study information

Verified date June 2024
Source University of Pittsburgh
Contact Christi Gomez
Phone ?(412) 969-3084?
Email clg166@pitt.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4600
Est. completion date September 30, 2027
Est. primary completion date September 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Community Resiliency Collective Efficacy Intervention (CRCEI)
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.
Health Education Sessions
Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions)

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in perceptions of neighborhood collective efficacy and community cohesion 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
Secondary Community incidence of violence in 12 month period 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
Secondary Community incidence of violence in 12 month period 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
Secondary Change from baseline in collective efficacy and neighborhood social norms 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
Secondary Number of self-reported events of violence exposure count of individual-level events of violence exposure Change from baseline to approximately 12 months after baseline
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