Firearm InjuryNCT05436457
Clinical Screening for Firearm Violence Risk
An observational study of Firearm Injury, run by University of Michigan at 4 sites in United States.
Trial summary
The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Firearm Injury
- How many people
- 1,506 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jul 2021to 22 Aug 2024
- Phase
- Observational
- 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Study population: Youth aged 18-24 seeking care at the Emergency departments of Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center
Who may be able to join
- Flint, Philadelphia, or Seattle Youth between the ages of 18-24 seeking care for any reason at Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center Emergency Department
- Can provide consent for the study
Who cannot join
- Do not understand English (<1% in prior work)
- Unable to provide consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
- ED visit requiring intensive psychosocial services (e.g., sexual assault, psychosis, active suicidal ideation, or child abuse)
- In active police custody/prisoners (as they cannot provide consent)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hurley Medical Center
Flint, Michigan, 48503
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Multi-site External Validation and Improvement of a Clinical Screening Tool for Future Firearm Violence
The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.
Read the detailed description
Firearm violence is a public health crisis in the United States, and new epidemiological data suggest we may have reached a new endemic level of firearm mortality in recent years. Youth are disproportionately affected by firearm violence, with those age 18-24 being demonstrably the highest risk group. This study will recruit 1,500 youth age 18-24 from urban emergency departments (EDs) in three broadly different locales-Flint, Philadelphia, and Seattle-and administer a baseline survey covering several domains of potential risk factors for future violence, and follow up with those youth at 6- and 12-months to ascertain the primary outcome-firearm violence involvement (as victim or perpetrator, including threats and sub-clinical injuries)-as well as the secondary outcomes: high-risk firearm behaviors, non-firearm violence, and violent injury. This work will generate new insights into the prediction of firearm violence, and will lay the ground for future research involving the development and testing of interventions for interpersonal firearm violence both by identifying potential high-leverage modifiable predictive factors, and by focusing on youth most in need of intervention.
- Conditions
- Firearm Injury
- Keywords
- Injury Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 18-24 Year Olds in Emergency Department | Individuals age 18-24 recruited from one of the four study sites in Flint (1 hospital), Seattle (1 hospital), and Philadelphia (2 hospitals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firearm Violence Involvement
The primary outcome for this study is firearm violence involvement, as perpetrator or victim. This will be measured in part by the Conflict Tactics Scale 2, as established by Straus et al. CTS-2 is comprised of a 6-point scale, measuring how often the respondent has experienced each type of violence, ranging from never to more than 20 times. The primary outcome here will be a binary indicator comprised of any affirmative response to the questions asked as part of items 1-3 below, or any firearm events found from the objective chart review.
- Two self-reported measurements of firearm violence perpetration adapted from the modified conflict tactics scale (CTS-2).
- Two self-reported measurements of firearm violence victimization adapted from the modified conflict tactics scale (CTS-2).
- Presentation to the emergency department for a firearm injury (ICD-10 codes: X72-X74, W32-W34, X93-X95), measured based on objective chart review during the one year following baseline.
Measured: 1 Year After Baseline ED Visit
Secondary outcomes (3)
Risky Firearm Behaviors
As established by Carter et al based on a) twelve items from the Tulane Youth Study that measure firearm carriage and discharge in high-risky situations (e.g., discharging a firearm while committing a crime, or carrying a firearm while using drugs); b) the four firearm violence perpetration/victimization outcomes listed under the primary outcome; and c) firearm violence threats (as victim or perpetrator), as measured by the modified conflict tactics scale (CTS-2)
Measured: 1 Year After Baseline ED Visit
Non-Firearm Violence
22 self-reported measurements for non-firearm violence perpetration (11 for partner, 11 for non-partner) adapted from the CTS-2, 22 self-reported measurements for non-firearm violence victimization (11 for partner, 11 for non-partner) adapted from the CTS-2, and 6 items about fighting, adapted from the National Longitudinal Study of Adolescent Health.
Measured: 1 Year After Baseline ED Visit
Violent Injury
Presentation to the emergency department for any violent injury, measured based on objective chart review during the one year following baseline.
Measured: 1 Year After Baseline ED Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start26 Jul 2021
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jason E. Goldstick, University of Michigan
- Investigators
- Jason E. Goldstick, PHD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436457
- Sponsor's protocol ID
- HUM00188023
- Other IDs
- 1R01CE003294-01
- Status last verified
- Aug 2024
- First submitted
- 22 Jun 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study completion, de-identified data will be curated and uploaded through the Inter-University Consortium for Political and Social Research (ICPSR) run through the University of Michigan. ICPSR stores, curates, and provides access to data generated through social research studies in service to open science, which acts in service to optimized data sharing, rigorous detailing of study methods and citations for measures, and ensuring long-term preservation of the study data. Through the data curation process, data are cleaned and standardized for use, and data documentation is rigorously developed so that data sets and the associated documentation can be understood at a basic by any potential users. The uploaded data will be de-identified to ensure no linkages to individual research participants and will exclude variables that could lead to deductive disclosure of the identity of any individual subjects.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site External Validation and Improvement of a Clinical Screening Tool for Future Firearm Violence
- ClinicalTrials.gov ID
- NCT05436457
- Acronym / sponsor ID
- HUM00188023
- Conditions
- Firearm Injury
- Keywords
- Injury Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,506 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- 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 the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.
Detailed description
Firearm violence is a public health crisis in the United States, and new epidemiological data suggest we may have reached a new endemic level of firearm mortality in recent years. Youth are disproportionately affected by firearm violence, with those age 18-24 being demonstrably the highest risk group. This study will recruit 1,500 youth age 18-24 from urban emergency departments (EDs) in three broadly different locales-Flint, Philadelphia, and Seattle-and administer a baseline survey covering several domains of potential risk factors for future violence, and follow up with those youth at 6- and 12-months to ascertain the primary outcome-firearm violence involvement (as victim or perpetrator, including threats and sub-clinical injuries)-as well as the secondary outcomes: high-risk firearm behaviors, non-firearm violence, and violent injury. This work will generate new insights into the prediction of firearm violence, and will lay the ground for future research involving the development and testing of interventions for interpersonal firearm violence both by identifying potential high-leverage modifiable predictive factors, and by focusing on youth most in need of intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-24 Year Olds in Emergency Department | – | –Individuals age 18-24 recruited from one of the four study sites in Flint (1 hospital), Seattle (1 hospital), and Philadelphia (2 hospitals) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Youth aged 18-24 seeking care at the Emergency departments of Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center
Key inclusion criteria (2 listed)
- Flint, Philadelphia, or Seattle Youth between the ages of 18-24 seeking care for any reason at Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center Emergency Department
- Can provide consent for the study
Key exclusion criteria (4 listed)
- Do not understand English (<1% in prior work)
- Unable to provide consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
- ED visit requiring intensive psychosocial services (e.g., sexual assault, psychosis, active suicidal ideation, or child abuse)
- In active police custody/prisoners (as they cannot provide consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Firearm Violence Involvement
Time frame: 1 Year After Baseline ED Visit
The primary outcome for this study is firearm violence involvement, as perpetrator or victim. This will be measured in part by the Conflict Tactics Scale 2, as established by Straus et al. CTS-2 is comprised of a 6-point scale, measuring how often the respondent has experienced each type of violence, ranging from never to more than 20 times. The primary outcome here will be a binary indicator comprised of any affirmative response to the questions asked as part of items 1-3 below, or any firearm events found from the objective chart review. 1. Two self-reported measurements of firearm violence perpetration adapted from the modified conflict tactics scale (CTS-2). 2. Two self-reported measurements of firearm violence victimization adapted from the modified conflict tactics scale (CTS-2). 3. Presentation to the emergency department for a firearm injury (ICD-10 codes: X72-X74, W32-W34, X93-X95), measured based on objective chart review during the one year following baseline.
3 secondary outcomes
Risky Firearm Behaviors
Time frame: 1 Year After Baseline ED Visit
Non-Firearm Violence
Time frame: 1 Year After Baseline ED Visit
Violent Injury
Time frame: 1 Year After Baseline ED Visit
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 27 Aug 2024.
- Individual participant dataSharing planned: Yes. After study completion, de-identified data will be curated and uploaded through the Inter-University Consortium for Political and Social Research (ICPSR) run through the University of Michigan. ICPSR stores, curates, and provides access to data generated through social research studies in service to open science, which acts in service to optimized data sharing, rigorous detailing of study methods and citations for measures, and ensuring long-term preservation of the study data. Through the data curation process, data are cleaned and standardized for use, and data documentation is rigorously developed so that data sets and the associated documentation can be understood at a basic by any potential users. The uploaded data will be de-identified to ensure no linkages to individual research participants and will exclude variables that could lead to deductive disclosure of the identity of any individual subjects.
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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.
Jason E. Goldstick, PHD principal investigator
University of Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Firearm Injury, run by University of Michigan at 4 sites 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 2 inclusion and 4 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Firearm Violence Involvement (time frame: 1 Year After Baseline ED Visit). 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 27 Aug 2024.