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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723614
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
61,770
2
43

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Name
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
61770 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
TRUE HAVEN: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Experimental: Intervention

The two components in the intervention arm of TRUE HAVEN 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.

Behavioral: Name
Description

Outcome Measures

Primary Outcome Measures

  1. Change in rates of gun violence [Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months]

    The primary outcome of this study is neighborhood rate of incident gun violence; these administrative data will be provided annually by the New Haven Police Department. This outcome is assessed among everyone in the neighborhoods.

Secondary Outcome Measures

  1. Change in neighborhood social cohesion [Baseline, 6 months, 12 months, and 24 months]

    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 a 4 point scale (score range: 1-4).

  2. Change in participant self-efficacy [Baseline, 6 months, 12 months, and 24 months]

    This outcome measures individual-level perceptions and reactions to life's situations. It will be measured using a survey among the about 1,400 recruited participants. The measure is based on a 4 point scale (score range: 1-4).

  3. Change in perceived health and well-being [Baseline, 6 months, 12 months, and 24 months]

    This outcome measures 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. It will be measured using a survey among the about 1,400 recruited participants. The measure is based on a 11 point scale (score range: 0-10).

  4. Change in financial security [Baseline, 6 months, 12 months, and 24 months]

    This outcome measures financial readiness for an emergency using a survey among the about 1,400 recruited participants. The measure is based on a 5 point scale (score range: 1-5).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Brita Roy, MD, MPH, MHS, New York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05723614
Other Study ID Numbers:
  • 2000032184
  • 1R01MD017526-01
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University

Study Results

No Results Posted as of Feb 13, 2023