Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)

NCT07305467 | Not Yet Recruiting

• 1 other identifier: HM300000392 Phase 1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prevention

Keywords

Firearm injury prevention; community based programs; youth advisory board

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  After the development of the document and through the end of the focus group development of the Intervention manual

Study Arms (2)

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).

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).

Other: Establish an advisory board of high-risk youth; Other: Feedback and advice sessions; Other: Youth advisory board training; Other: Semi-structured focus groups

Interventions

Establish an advisory board of high-risk youth OTHER

Fifteen high-risk youth will be recruited to establish an advisory board

Youth Participatory Action Research (YPAR) Advisory Board

Feedback and advice sessions OTHER

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 Participatory Action Research (YPAR) Advisory Board

Youth advisory board training OTHER

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.

Youth Participatory Action Research (YPAR) Advisory Board

Semi-structured focus groups OTHER

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.

Interviewees; Youth Participatory Action Research (YPAR) Advisory Board

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Kelly O'Connor

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly O'Connor

CONTACT

804-628-6294; kelly.oconnor@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I will include focus groups youth interviews (n=30) and a youth advisory board (n=15)

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)