NCT05768217

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,600

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jun 2024Sep 2027

First Submitted

Initial submission to the registry

February 18, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

February 18, 2023

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Community incidence of violence in 12 month period

    Change from 1 year period before baseline to approximately 12 months after baseline

  • Community incidence of violence in 12 month period

    Change from 1 year period before baseline to approximately 2 years after baseline

  • Change from baseline in collective efficacy and neighborhood social norms

    Change from baseline to approximately 12 months after baseline

  • Number of self-reported events of violence exposure

    Change from baseline to approximately 12 months after baseline

Study Arms (2)

Community Resiliency Collective Efficacy Intervention (CRCEI)

EXPERIMENTAL

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)

Health Education Sessions

ACTIVE COMPARATOR

Comparison neighborhoods will receive health education sessions as a control intervention. (9 sessions)

Behavioral: Health Education Sessions

Interventions

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.

Community Resiliency Collective Efficacy Intervention (CRCEI)

Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions)

Health Education Sessions

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • individuals younger than 13 years old
  • individuals residing outside of participating neighborhoods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Elizabeth Miller, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Miller, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 14, 2023

Study Start

June 24, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 months after data collection is completed.
Access Criteria
Data sharing agreement must be completed with investigators and the University of Pittsburgh.

Locations