ViolenceAIMNCT02174224
At-risk Intervention and Mentoring Evaluation
A study testing Brief Intervention, Case Management and Standard Medical Care in people with Violence, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Violence
- What is being tested?
- Brief Intervention, Case Management and Standard Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)
Who cannot join
- Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
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.
Read the detailed description
This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.
Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.
Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).
- Conditions
- Violence
- Being tested
- Brief Intervention, Case Management, Standard Medical Care
- Keywords
- Violence, At-risk youth, Intentional Injury, Violence Intervention, Youth, recidivism
- Medical subject headings
- Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
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.
Case ManagementBehavioural
Case management based on needs-assessment. Resource connection and mentoring.
Standard Medical CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief Intervention; Behavioral: Case Management; Behavioral: Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6, 12, 18 months
Secondary outcomes (7)
Composite Score
Composite Score measures both risk and protective factors. This weighted scale uses the interplay between risk and protective factors to determine overall risk for youth to become violently injured.
Measured: 0, 6, 12, 18 months
School Enrollment
Self-report for school enrollment will be measured and compared among arms.
Measured: 0, 6, 12, 18 months
Hospital Recidivism
Every six month, patients' medical records will be scanned to determine if there has been violent injury recidivism. Medical release of Information forms will allow medical record searches from other local hospitals.
Measured: 0, 6, 12, 18 months
Justice System Recidivism
Self-report of criminal history.
Measured: 0, 6, 12, 18 months
Employment
Self-report of employment status.
Measured: 0, 6, 12, 18 months
Resource Utilization
Self report of resource utilization for health care and social needs.
Measured: 0, 6, 12, 18 months.
Mortality
Mortality will be assessed every 6 months.
Measured: 0, 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Bakes, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174224
- Sponsor's protocol ID
- OJJDP-2013-3579
- Acronym
- AIM
- Status last verified
- Feb 2021
- First submitted
- 23 Jun 2014
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
- ClinicalTrials.gov ID
- NCT02174224
- Acronym / sponsor ID
- AIM / OJJDP-2013-3579
- Conditions
- Violence
- Keywords
- Violence, At-risk youth, Intentional Injury, Violence Intervention, Youth, recidivism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.
Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.
Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMC + BI + Case Management | Experimental | Behavioral: Brief Intervention, Behavioral: Case Management, Behavioral: Standard Medical CareThis 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)
Key exclusion criteria (1 listed)
- Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionGoals 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. | Behavioural | SMC + BI + Case Management |
| Case ManagementCase management based on needs-assessment. Resource connection and mentoring. | Behavioural | SMC + BI + Case Management |
| Standard Medical CareThis 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. | Behavioural | SMC + BI + Case Management |
Primary outcome
Violence Risk Scale
Time frame: 0, 6, 12, 18 months
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.
7 secondary outcomes
Composite Score
Time frame: 0, 6, 12, 18 months
School Enrollment
Time frame: 0, 6, 12, 18 months
Hospital Recidivism
Time frame: 0, 6, 12, 18 months
Justice System Recidivism
Time frame: 0, 6, 12, 18 months
Employment
Time frame: 0, 6, 12, 18 months
Resource Utilization
Time frame: 0, 6, 12, 18 months.
Mortality
Time frame: 0, 6, 12, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Virtual Reality Intervention (VR-GINSO) for Reducing Aggression in Young Offenders
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Adjunctive Motivational Alcohol Intervention to Prevent IPV
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YES: Innovative Discussion for Engagement, Achievement, and Service
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Bakes, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention, Case Management and Standard Medical Care in people with Violence, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Violence Risk Scale (time frame: 0, 6, 12, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.