NCT05723614

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
61,770

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

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 Progress74%
Feb 2023Jul 2027

First Submitted

Initial submission to the registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

February 1, 2023

Last Update Submit

February 11, 2026

Conditions

Keywords

gun violencestructural racism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale

    Baseline, 6 months, 12 months, and 24 months

  • Change in participant self-efficacy based on the Generalized Self-Efficacy Scale

    Baseline, 6 months, 12 months, and 24 months

  • Change in perceived health and well-being based on the Well-being Assessment

    Baseline, 6 months, 12 months, and 24 months

  • Change in financial security

    Baseline, 6 months, 12 months, and 24 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

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: TRUE HAVEN

Interventions

TRUE HAVENBEHAVIORAL

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.

Intervention

Eligibility Criteria

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

You may not qualify if:

  • Age 18 or above
  • Family member currently incarcerated or person returning from prison within the last 12 months
  • Live in one of the seven neighborhoods with highest rates of gun violence in New Haven, Connecticut
  • Plans to leave the study area within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beaver Hills

New Haven, Connecticut, 06511, United States

RECRUITING

Dixwell

New Haven, Connecticut, 06511, United States

RECRUITING

Dwight/West River

New Haven, Connecticut, 06511, United States

RECRUITING

Fair Haven

New Haven, Connecticut, 06513, United States

RECRUITING

Hill North and South

New Haven, Connecticut, 06513, United States

RECRUITING

Newhallville

New Haven, Connecticut, 06514, United States

RECRUITING

West Rock/West Hills

New Haven, Connecticut, 06515, United States

RECRUITING

Related Publications (2)

  • Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. Trusted residents and housing assistance to decrease violence exposure in New Haven (TRUE HAVEN): a strengths-based and community-driven stepped-wedge intervention to reduce gun violence. BMC Public Health. 2023 Aug 14;23(1):1545. doi: 10.1186/s12889-023-15997-x.

  • Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. TRUsted rEsidents and Housing Assistance to decrease Violence Exposure in New Haven (TRUE HAVEN): A strengths-based and community-driven stepped-wedge intervention to reduce gun violence. Res Sq [Preprint]. 2023 May 10:rs.3.rs-2874381. doi: 10.21203/rs.3.rs-2874381/v1.

MeSH Terms

Conditions

Systemic Racism

Condition Hierarchy (Ancestors)

RacismPrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Emily Wang, MD, MAS

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Wang, MD, MAS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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 700. The other component of the intervention is mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 13, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Deidentified data will be made publicly available following study completion.

Time Frame
One year following the end of the funding.
Access Criteria
One year after the end of study funding, the de-identified data will be available upon request to the principal investigators of the study (Brita Roy, Brita.Roy@nyulangone.org; Virginia Spell, vtspell@ulsc.org; Emily Wang, emily.wang@yale.edu)

Locations