Violence, PhysicalNCT05768217
Community Resiliency Collective Efficacy Intervention
A study testing Community Resiliency Collective Efficacy Intervention (CRCEI) and Health Education Sessions in people with Violence, Physical and Violence, Non-accidental, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Violence, Physical, Violence, Non-accidental, Violence, Sexual
- What is being tested?
- Community Resiliency Collective Efficacy Intervention (CRCEI) and Health Education Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,600 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- individuals younger than 13 years old
- individuals residing outside of participating neighborhoods
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Violence, Physical, Violence, Non-accidental, Violence, Sexual, Violence, Domestic, Violence, Structural, Violence in Adolescence
- Being tested
- Community Resiliency Collective Efficacy Intervention (CRCEI), Health Education Sessions
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Resiliency Collective Efficacy Intervention (CRCEI)Behavioural
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 SessionsBehavioural
Comparison neighborhoods will receive health education sessions across a variety of community-identified health topics as a control intervention. (9 sessions)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Behavioral: Health Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to approximately 12 months after baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from baseline to approximately 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start24 Jun 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, PhysicalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Alison Culyba, University of Pittsburgh
- Investigators
- Alison Culyba, MD, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768217
- Sponsor's protocol ID
- STUDY22100193
- Other IDs
- U01CE003524-01
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.