Community Resiliency Collective Efficacy Intervention

Community Resiliency Collective Efficacy Intervention (CRCEI) for Prevention of Community Violence - A Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Violence, Domestic; Violence in Adolescence; Violence, Sexual; Violence, Physical; Violence, Non-accidental; Social Cohesion; Violence, Structural; Community Violence
• Intervention / Treatment: Behavioral: Community Resiliency Collective Efficacy Intervention (CRCEI); Behavioral: Health Education Sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 4600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Miller, MD, PhD; Phone Number: 412-692-8504; Email: elizabeth.miller@chp.edu
• Study Contact Backup: Name: Christi Gomez; Phone Number: ‪(412) 969-3084‬; Email: clg166@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Elizabeth Miller, MD, PhD; Phone Number: 412-692-6677; Email: elizabeth.miller@chp.edu
      • Contact: Alison Culyba, MD, PhD; Phone Number: 412-692-6677; Email: alison.culyba@chp.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
Active Comparator: Health Education Sessions; Comparison neighborhoods will receive health education sessions as a control intervention. (9 sessions)	Behavioral: Health Education Sessions; Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Elizabeth Miller, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY22100193; U01CE003524-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 12 months after data collection is completed.
• IPD Sharing Access Criteria: Data sharing agreement must be completed with investigators and the University of Pittsburgh.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No