NCT07539142

Brief Summary

The present study will use an optimization randomized control trial design to test the preliminary efficacy of a Hospital-based Violence Intervention Program (HVIP) in Central Arkansas.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 Progress7%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

June 2, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 13, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Risky Firearm Behaviors

    Composite measure uses items adapted from the Tulane University National Youth Study capturing frequency and severity of risky firearm-related behaviors (i.e. carriage, threats, etc.) (0=Never; 6=20+ Times)

    Baseline, 3-month, 6-month, 9-month, and 12 months

Secondary Outcomes (4)

  • Change in PTSD

    Baseline, 3-month, 6-month, 9-month, and 12 months

  • Change in Anxiety

    Baseline, 3-month, 6-month, 9-month, and 12 months

  • Change in Depression

    Baseline, 3-month, 6-month, 9-month, and 12 months

  • Change in Feasibility and Acceptability of Intervention

    3-month, 6-month, 9-month, and 12 months

Study Arms (8)

BB, CM, G

EXPERIMENTAL

Participants receive brief bedside, case management+ voucher, and SELF group intervention components.

Behavioral: Brief BedsideBehavioral: Case Management + VoucherBehavioral: SELF Group Therapy Sessions

BB, CM

EXPERIMENTAL

Participants receive brief bedside and case management+ voucher intervention components.

Behavioral: Brief BedsideBehavioral: Case Management + Voucher

BB, G

EXPERIMENTAL

Participants receive brief bedside and SELF group intervention components.

Behavioral: Brief BedsideBehavioral: SELF Group Therapy Sessions

BB

EXPERIMENTAL

Participants receive brief bedside intervention component.

Behavioral: Brief Bedside

ALL

EXPERIMENTAL

Participants receive brief bedside, peer support, case management+ voucher, and SELF group intervention components.

Behavioral: Brief BedsideBehavioral: Peer SupportBehavioral: Case Management + VoucherBehavioral: SELF Group Therapy Sessions

BB, PS, CM

EXPERIMENTAL

Participants receive brief bedside, peer support, and case management+ voucher intervention components.

Behavioral: Brief BedsideBehavioral: Peer SupportBehavioral: Case Management + Voucher

BB, PS, G

EXPERIMENTAL

Participants receive brief bedside, peer support, and SELF group intervention components.

Behavioral: Brief BedsideBehavioral: Peer SupportBehavioral: SELF Group Therapy Sessions

BB, PS

EXPERIMENTAL

Participants receive brief bedside and peer support intervention components.

Behavioral: Brief BedsideBehavioral: Peer Support

Interventions

Brief BedsideBEHAVIORAL

* Initial support (in-hospital or shortly after if discharged early) * Needs assessment * Resource Sheet of Vetted Partners

ALLBBBB, CMBB, CM, GBB, GBB, PSBB, PS, CMBB, PS, G
Peer SupportBEHAVIORAL

* Weekly Check-ins * Status Check (Personal/family; Health; Mental Health; Spiritual, etc.) * Encouragement/Motivation (Staying safe, Doing right, etc.) * In-Person Visits (Home, Rehab, etc.) * Peer Social/Skill-building Activities (Money management, Job interviewing, Computer literacy, Creative arts, Critical thinking film discussions, etc.)

ALLBB, PSBB, PS, CMBB, PS, G

* Service Plan \& Referrals * Service Check-in/Follow up with partners and participants * Navigation of Health Care and Social Service Follow up appointments * Transportation Assistance * Basic life skills for service provision (riding bus/public transportation, zoom, etc.) * Vouchers for Immediate Needs/Obstacles

ALLBB, CMBB, CM, GBB, PS, CM

* Virtual Bi-weekly Group Therapy * SELF Curriculum- Trauma Focused Cognitive Behavioral Therapy * Lead by Therapists and Community Peer Volunteers * One-on-one Introductory/Intake Orientations

ALLBB, CM, GBB, GBB, PS, G

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years of age or older
  • Currently live in Central Arkansas
  • Currently being treated for a penetrating gun assault injury at a local hospital

You may not qualify if:

  • Participants must not:
  • Report any medical problems that would limit their ability to express thoughts and answer questions (i.e. active intoxication, developmental delays, dementia, psychosis, etc.)
  • Be currently under arrest or in police custody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Nakita Lovelady, PhD, MPH

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nakita Lovelady, PhD, MPH

CONTACT

Joyce Raynor, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Interventionists (peer community health workers, case managers) will only know which participants are assigned to their intervention component. Only the UAMS PI and research staff will know the interventions assigned to each participant.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The optimization randomized control trial design will entail a factorial experiment with eight experimental conditions to test the targeted outcomes. The eight conditions will include various combinations of four intervention components (brief bedside, peer support, case management, and group therapy), with the brief bedside serving as the constant and the other components being on or off across conditions. Additionally, the investigators will maintain a hybrid effectiveness implementation approach by assessing health outcomes along with implementation outcomes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

June 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations