A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence.
J Trauma Acute Care Surg
; 96(4): 641-649, 2024 Apr 01.
Article
en En
| MEDLINE
| ID: mdl-37602906
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Violencia con Armas
/
Trastornos Mentales
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Qualitative_research
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Screening_studies
Aspecto:
Determinantes_sociais_saude
Límite:
Humans
Idioma:
En
Revista:
J Trauma Acute Care Surg
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Estados Unidos