A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence.

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.