TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven

Firearm Injury Clinical Trial

— TRUE HAVEN  

Official title:

TRUE HAVEN: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723614
• Other study ID #: 2000032184
• Secondary ID: 1R01MD017526-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: Brita Roy, MD, MPH, MHS
• Phone: (347) 377-3157
• Email: brita.roy[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61770
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Firearm Injury

Intervention

Behavioral:
• TRUE HAVEN
The two components of the TRUE HAVEN intervention are: housing support for recently incarcerated people as well as family members of currently incarcerated people, and mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.

Locations

Country	Name	City	State
United States	Beaver Hills	New Haven	Connecticut
United States	Newhallville	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rates of gun violence	The neighborhood rate of incident gun violence assessed among everyone in the neighborhoods; these data will be provided annually by the New Haven Police Department.	Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Secondary	Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale	This is a neighborhood-level outcome on residents' perception of the strengths of relationships and solidarity among their neighbors. Data will be provided annually from DataHaven based on a representative sample of approximately 1% of population across each neighborhood of New Haven. The measure is based on Social Cohesion sub-scale of the Sampson Collective Efficacy Scale, which is a 5-point scale (score range: 1(strongly disagree) to 5(strongly agree)).	Baseline, 6 months, 12 months, and 24 months
Secondary	Change in participant self-efficacy based on the Generalized Self-Efficacy Scale	Individual-level perceptions and reactions to life's situations will be measured using a survey among the about 1,400 recruited participants. The measure is based on the Generalized Self-Efficacy Scale, which is a 4-point scale (score range: 1(not at all true) to 4(exactly true)).	Baseline, 6 months, 12 months, and 24 months
Secondary	Change in perceived health and well-being based on the Well-being Assessment	Individual-level perceived health and well-being including dimensions of subjective well-being, general health, health problems, sense of direction and purpose in life, emotional support, and sense of belonging to community will be measured using a survey among the about 1,400 recruited participants. This composite measure is based on Well-being Assessment (Adult - 12 items) - 100 Million Healthier Lives. Each item is an 11-point scale (score range: 0(worst) to 10(best)). Higher scores indicate better perceived health and well-being.	Baseline, 6 months, 12 months, and 24 months
Secondary	Change in financial security	Financial readiness for an emergency will be assessed using a survey among the recruited participants. The measure is based on one 5-point item (score range: 1(worst) to 5(best)) measuring financial capability.	Baseline, 6 months, 12 months, and 24 months