NCT02174224

Brief Summary

The purpose of this study is to determine if a hospital-based violence intervention programs can make sustainable behavior changes in at-risk youth using two key components, brief intervention at the hospital bedside and case management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

June 23, 2014

Last Update Submit

February 9, 2021

Conditions

Keywords

ViolenceAt-risk youthIntentional InjuryViolence InterventionYouthrecidivism

Outcome Measures

Primary Outcomes (1)

  • Violence Risk Scale

    Violence Risk Scale (VRS) will be measured with each youth at 4 time points. Change over time will be assessed and compared among study arms.

    0, 6, 12, 18 months

Secondary Outcomes (7)

  • Composite Score

    0, 6, 12, 18 months

  • School Enrollment

    0, 6, 12, 18 months

  • Hospital Recidivism

    0, 6, 12, 18 months

  • Justice System Recidivism

    0, 6, 12, 18 months

  • Employment

    0, 6, 12, 18 months

  • +2 more secondary outcomes

Study Arms (1)

SMC + BI + Case Management

EXPERIMENTAL

This arm will include all interventions in Standard Medical Care + Brief Intervention Arm. Case management will also be given to this arm. General needs based assessments will be conducted by the outreach worker. These assessments will be done at the hospital or at the youth's home, whichever they prefer. This assessment tool addresses education, vocational training, employment, housing, medical insurance, follow-up care and pro-social activities. Although each youth in this arm will receive the same needs-based assessment, individual youth will have variable needs, which will guide each unique and individualized case management plan.

Behavioral: Brief InterventionBehavioral: Case ManagementBehavioral: Standard Medical Care

Interventions

Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient. The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.

SMC + BI + Case Management
Case ManagementBEHAVIORAL

Case management based on needs-assessment. Resource connection and mentoring.

SMC + BI + Case Management

This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient. This will also include a list of resources that are typically needed and used for violently injured youth.

SMC + BI + Case Management

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)

You may not qualify if:

  • Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Recidivism

Interventions

Crisis InterventionCase Management

Condition Hierarchy (Ancestors)

Criminal BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPatient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Katie Bakes, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations