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

February 11, 2026 updated by: Yale University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Proposed is a type I hybrid effectiveness/implementation study using a neighborhood-level, stepped-wedge trial design across seven primarily 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61770

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
      • New Haven, Connecticut, United States, 06514
        • Recruiting
        • Newhallville
        • Contact:
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
      • New Haven, Connecticut, United States, 06513
        • Recruiting
        • Fair Haven
        • Contact:
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
      • New Haven, Connecticut, United States, 06513
        • Recruiting
        • Hill North and South
        • Contact:
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Dixwell
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
        • Contact:
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Dwight/West River
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
        • Contact:
      • New Haven, Connecticut, United States, 06515
        • Recruiting
        • West Rock/West Hills
        • Sub-Investigator:
          • Christine Montgomery
        • Principal Investigator:
          • Virginia Spell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 seven neighborhoods with highest rates of gun violence in New Haven, Connecticut

Exclusion criteria:

  • Plans to leave the study area within 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in rates of gun violence
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale
Time Frame: 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 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
Change in financial security
Time Frame: Baseline, 6 months, 12 months, and 24 months
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
Change in participant self-efficacy based on the Generalized Self-Efficacy Scale
Time Frame: Baseline, 6 months, 12 months, and 24 months
Individual-level perceptions and reactions to life's situations will be measured using a survey among the about 700 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
Change in perceived health and well-being based on the Well-being Assessment
Time Frame: Baseline, 6 months, 12 months, and 24 months
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 700 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Wang, MD, MAS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000032184
  • 1R01MD017526-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be made publicly available following study completion.

IPD Sharing Time Frame

One year following the end of the funding.

IPD Sharing 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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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