%0 Randomized Controlled Trial
%T A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence.
%A O'Neill KM
%A Schenck C
%A Vega P
%A Gawel M
%A Dodington J
%J J Trauma Acute Care Surg
%V 96
%N 4
%D 2024 Apr 1
%M 37602906
%F 3.697
%R 10.1097/TA.0000000000004121
%X <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.<BR><B>METHODS: </B>Prognostic and Epidemiological; Level IV.