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Abstract
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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 IIStudy Type: Original research.
Language: en |