PreventionNCT07305467
Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)
A study testing Establish an advisory board of high-risk youth, Feedback and advice sessions and Youth advisory board training in people with Prevention, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Prevention
- What is being tested?
- Establish an advisory board of high-risk youth, Feedback and advice sessions and Youth advisory board training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth aged approximately 13-17 years.
- Identified as at elevated risk for firearm-related injury (e.g., history of violent injury, referred by violence prevention programs).
- Able to provide assent (and parental/guardian consent if under 18).
- Sufficient proficiency in English to complete study procedures.
Who cannot join
- Significant cognitive impairment or developmental disability that would preclude comprehension of the intervention content or study procedures.
- Current psychiatric or medical instability requiring immediate treatment or hospitalization. - Non-English speaking (due to limited resources for translation of study measures and intervention materials in this pilot).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Kelly O'Connor
About this study
Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.
Read the detailed description
This study will utilize youth participatory action research (YPAR) to co-develop the SAFE Futures intervention. The SAFE Futures Intervention is a grounded theory of firearm-related behavior change, and it has developed the SAFE Futures single-session intervention through focus groups and youth participatory action research.
The study is designed to determine whether adding SAFE Futures to the Emerging Leaders program reduces risk factors associated with intentional firearm violence and suicide among high-risk youth. An advisory board of N=15 high-risk youth will be recruited, and data from focus groups will be analyzed using grounded theory methodology to examine attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage). The youth advisory board will use the resulting theory to develop SAFE Futures.
- Conditions
- Prevention
- Being tested
- Establish an advisory board of high-risk youth, Feedback and advice sessions, Youth advisory board training, Semi-structured focus groups
- Keywords
- Firearm injury prevention, community based programs, youth advisory board
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establish an advisory board of high-risk youthOther
Fifteen high-risk youth will be recruited to establish an advisory board
Feedback and advice sessionsOther
The youth advisory board will provide feedback and advice on the research questions, methodology, and interpretation of data through approximately fifteen, 60-minute meetings
Youth advisory board trainingOther
Youth will be trained in the social-ecological model and health behavior change theories, to better conceptualize the link between theory and intervention content, and to participate in the research process more actively.
Semi-structured focus groupsOther
Will participate in a semi-structured focus group protocol developed in collaboration with the youth advisory board while incorporating knowledge from the empirical literature and health behavior change theories.
| Study group | Role | What they receive |
|---|---|---|
| Interviewees | Other | Interviews with youth (30 participants) to identify relevant firearm-specific risk and protective factors that will be used to develop the theory and intervention in collaboration with an advisory board of 15 youth. (Members of the YPAR are eligible to participate in both arms). Receives: Other: Semi-structured focus groups |
| Youth Participatory Action Research (YPAR) Advisory Board | Other | The advisory board of 15 youth. The advisory board will assist in developing the focus group protocol for Phase 1 qualitative data collection. (Members of the YPAR are eligible to participate in both arms). Receives: Other: Establish an advisory board of high-risk youth; Other: Feedback and advice sessions; Other: Youth advisory board training; Other: Semi-structured focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grounded theory of firearm related change
A document that outlines the description of the attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage), designed by the Youth Participatory Action Research (YPAR) Advisory Board during their fifteen, 60-min meetings.
Measured: Fifteen, 60-minute meetings (Baseline to the completion of the document)
SAFE Futures content
Intervention manual developed by the focus group interactions with the interviewees
Measured: After the development of the document and through the end of the focus group development of the Intervention manual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start30 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase I will include focus groups youth interviews (n=30) and a youth advisory board (n=15)
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kelly O'Connor, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305467
- Sponsor's protocol ID
- HM300000392 Phase 1
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)
- ClinicalTrials.gov ID
- NCT07305467
- Acronym / sponsor ID
- HM300000392 Phase 1
- Conditions
- Prevention
- Keywords
- Firearm injury prevention, community based programs, youth advisory board
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Dec 2025 (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.
Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.
Detailed description
This study will utilize youth participatory action research (YPAR) to co-develop the SAFE Futures intervention. The SAFE Futures Intervention is a grounded theory of firearm-related behavior change, and it has developed the SAFE Futures single-session intervention through focus groups and youth participatory action research.
The study is designed to determine whether adding SAFE Futures to the Emerging Leaders program reduces risk factors associated with intentional firearm violence and suicide among high-risk youth. An advisory board of N=15 high-risk youth will be recruited, and data from focus groups will be analyzed using grounded theory methodology to examine attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage). The youth advisory board will use the resulting theory to develop SAFE Futures.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I will include focus groups youth interviews (n=30) and a youth advisory board (n=15)
| Arm | Type | Receives |
|---|---|---|
| Interviewees | Other | Other: Semi-structured focus groupsInterviews with youth (30 participants) to identify relevant firearm-specific risk and protective factors that will be used to develop the theory and intervention in collaboration with an advisory board of 15 youth. (Members of the YPAR are eligible to participate in both arms). |
| Youth Participatory Action Research (YPAR) Advisory Board | Other | Other: Establish an advisory board of high-risk youth, Other: Feedback and advice sessions, Other: Youth advisory board training, Other: Semi-structured focus groupsThe advisory board of 15 youth. The advisory board will assist in developing the focus group protocol for Phase 1 qualitative data collection. (Members of the YPAR are eligible to participate in both arms). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Youth aged approximately 13-17 years.
- Identified as at elevated risk for firearm-related injury (e.g., history of violent injury, referred by violence prevention programs).
- Able to provide assent (and parental/guardian consent if under 18).
- Sufficient proficiency in English to complete study procedures.
Key exclusion criteria (2 listed)
- Significant cognitive impairment or developmental disability that would preclude comprehension of the intervention content or study procedures.
- Current psychiatric or medical instability requiring immediate treatment or hospitalization. - Non-English speaking (due to limited resources for translation of study measures and intervention materials in this pilot).
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 |
|---|---|---|
| Establish an advisory board of high-risk youthFifteen high-risk youth will be recruited to establish an advisory board | Other | Youth Participatory Action Research (YPAR) Advisory Board |
| Feedback and advice sessionsThe youth advisory board will provide feedback and advice on the research questions, methodology, and interpretation of data through approximately fifteen, 60-minute meetings | Other | Youth Participatory Action Research (YPAR) Advisory Board |
| Youth advisory board trainingYouth will be trained in the social-ecological model and health behavior change theories, to better conceptualize the link between theory and intervention content, and to participate in the research process more actively. | Other | Youth Participatory Action Research (YPAR) Advisory Board |
| Semi-structured focus groupsWill participate in a semi-structured focus group protocol developed in collaboration with the youth advisory board while incorporating knowledge from the empirical literature and health behavior change theories. | Other | Interviewees, Youth Participatory Action Research (YPAR) Advisory Board |
Primary outcome
Grounded theory of firearm related change
Time frame: Fifteen, 60-minute meetings (Baseline to the completion of the document)
A document that outlines the description of the attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage), designed by the Youth Participatory Action Research (YPAR) Advisory Board during their fifteen, 60-min meetings.
SAFE Futures content
Time frame: After the development of the document and through the end of the focus group development of the Intervention manual
Intervention manual developed by the focus group interactions with the interviewees
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
Kelly O'Connor principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Establish an advisory board of high-risk youth, Feedback and advice sessions and Youth advisory board training in people with Prevention, run by Virginia Commonwealth University 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly O'Connor (804-628-6294, kelly.oconnor@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grounded theory of firearm related change (time frame: Fifteen, 60-minute meetings (Baseline to the completion of the document)). The study lists 2 primary outcomes in all. 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 3 Sep 2026.