A Pilot Clinical Trial of the Screening and Tool for Awareness and Relief of Trauma (START) for Survivors of Gun Violence
Kathleen M. O’Neill, Christopher Schenck, Pepe Vega, Marcie Gawel, James Dodington- Critical Care and Intensive Care Medicine
- Surgery
Abstract
Background
Survivors of gun violence have significant sequelae including re-injury 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 that 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 as well as 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 PCL-C in the control compared with a 10.7-point decrease in the treatment group for the first month.
Conclusions
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
Level II
Study Type: Original research