Clinical trial NCT05723614: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
Official title: TRUE HAVEN: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Firearm Injury
Keywords: gun violence
structural racism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-13
Enrollment: 61770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: One component of the intervention will focus on providing housing support for recently incarcerated people as well as family members of currently incarcerated people. The target sample size is about 1,400. The other component of the intervention is mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.
Primary purpose: PREVENTION

Brief summary: The overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and (2) fostering greater support for mental health by training a trusted network of community members in trauma-informed counseling.

Detailed description: Proposed is a type I hybrid effectiveness/implementation study using a neighborhood-level, stepped-wedge trial design across six primarily Black/Latinx, socially vulnerable neighborhoods in New Haven. Residents of each neighborhood who have been affected by incarceration (i.e., currently have a family member incarcerated or a person returning to the community from prison within the last 12 months) will be eligible for our intervention for a period of 6 months. The Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science frameworks will be used to measure and track processes in achieving outcomes. A mixed methods approach will be used, primarily the use of quantitative methods for this study, along with qualitative focus groups will be conducted to assess some implementation outcomes. The primary outcome, rates of gun violence at the neighborhood level, are obtained from administrative data. Survey data will be collected for some implementation process measures (e.g., assessing acceptability and appropriateness of the intervention).

Eligibility criteria: All residents in the study neighborhoods are eligible for outcome assessment. For the intervention component of housing support, the below inclusion and exclusion criteria apply.

Inclusion criteria:

* Age 18 or above
* Family member currently incarcerated or person returning from prison within the last 12 months
* Live in one of the six neighborhoods with highest rates of gun violence in New Haven, Connecticut

Exclusion criteria:

* Plans to leave the study area within 1 year

Primary outcomes:
measure: Change in rates of gun violence
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Secondary outcomes:
measure: Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale
timeFrame: Baseline, 6 months, 12 months, and 24 months
measure: Change in participant self-efficacy based on the Generalized Self-Efficacy Scale
timeFrame: Baseline, 6 months, 12 months, and 24 months
measure: Change in perceived health and well-being based on the Well-being Assessment
timeFrame: Baseline, 6 months, 12 months, and 24 months
measure: Change in financial security
timeFrame: Baseline, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Beaver Hills
state: Connecticut
city: New Haven
country: United States
facility: Fair Haven
state: Connecticut
city: New Haven
country: United States
facility: Hill North and South
state: Connecticut
city: New Haven
country: United States
facility: Newhallville
state: Connecticut
Study officials:
affiliation: Yale University
name: Emily Wang, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: