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

NCT ID: NCT07305467

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

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.

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

Keywords

Firearm injury prevention; community based programs; youth advisory board

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interviewees

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).

Group Type: OTHER

Semi-structured focus groups

Intervention Type: 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.

Youth Participatory Action Research (YPAR) Advisory Board

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).

Group Type: OTHER

Establish an advisory board of high-risk youth

Intervention Type: OTHER

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

Feedback and advice sessions

Intervention Type: 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 advisory board training

Intervention Type: 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.

Semi-structured focus groups

Intervention Type: 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.

Interventions

Establish an advisory board of high-risk youth

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

Intervention Type: OTHER

Feedback and advice sessions

The youth advisory board will provide feedback and advice on the research questions, methodology, and interpretation of data through approximately fifteen, 60-minute meetings

Intervention Type: OTHER

Youth advisory board training

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.

Intervention Type: OTHER

Semi-structured focus groups

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly O'Connor

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Central Contacts

Kelly O'Connor

Role: CONTACT

Phone: 804-628-6294

Email: kelly.oconnor@vcuhealth.org

Facility Contacts

Kelly O'Connor

Role: primary

Other Identifiers

HM300000392 Phase 1

Identifier Type: -

Identifier Source: org_study_id