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Not yet recruiting NCT07305467

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

No phase Interventional Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Establish an advisory board of high-risk youth, Feedback and advice sessions, Youth advisory board training, Semi-structured focus groups.
Who it may be relevant to
Registry conditions: Prevention. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Establish an advisory board of high-risk youth
    Fifteen high-risk youth will be recruited to establish an advisory board
  • 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
  • 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.
  • 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.

Primary outcome measures

  • Grounded theory of firearm related change [Time frame: Fifteen, 60-minute meetings (Baseline to the completion of the document)]
  • SAFE Futures content [Time frame: After the development of the document and through the end of the focus group development of the Intervention manual]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07305467 · HM300000392 Phase 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗