학술논문

A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence
Document Type
Academic Journal
Source
Journal of Trauma and Acute Care Surgery. Apr 01, 2024 96(4):641-649
Subject
Language
English
ISSN
2163-0755
Abstract
BACKGROUND: Survivors of gun violence have significant sequelae including reinjury with a firearm and mental health disorders that often go undiagnosed and untreated. The Screening and Tool for Awareness and Relief of Trauma (START) is a targeted behavioral mental health intervention developed for patients who come from communities of color with sustained and persistent trauma. METHODS: In this pilot study, we evaluate the feasibility of completing a randomized controlled trial to test the START intervention. Using a mixed methods study design, we used both quantitative and qualitative data collection to assess the START intervention and the feasibility of completing a randomized controlled trial. The purpose of this study was to estimate important study parameters that would enable a future randomized controlled trial. RESULTS: We were able to make conclusions about several crucial domains of a behavioral intervention trial: (1) recruitment and retention—we had a high follow-up rate, but our recruitment was low (34% of eligible participants); (2) acceptability of the intervention—the addition of audiovisual resources would make the tools more accessible; (3) feasibility of the control—more appropriate for a stepped wedge cluster randomized controlled trial design; (4) intervention fidelity—there was an 81% concordance rate between the fidelity survey results and the audio recordings; (5) approximate effect size—there was a 0.4-point decrease in the PTSD Checklist—Civilian Version in the control compared with a 10.7-point decrease in the treatment group for the first month. CONCLUSION: While it was feasible to conduct a randomized controlled trial, our findings suggest that a stepped wedge cluster randomized controlled trial design may be the most successful trial design for the START intervention. In addition, the inclusion of a “credible messenger” to recruit participants into the study and the development of audiovisual resources for START would improve recruitment and effectiveness. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.