O'Neill Kathleen M, Schenck Christopher, Vega Pepe, Gawel Marcie, Dodington James
From the Division of General Surgery, Trauma, and Surgical Critical Care, Department of Surgery (K.M.O.), Investigative Medicine Program (K.M.O., C.S.), Yale Graduate School of Arts and Sciences, and Department of Pediatrics (J.D.), Yale School of Medicine; Violence Intervention Program (P.V., M.G., J.D.), Yale New Haven Hospital, New Haven, Connecticut.
J Trauma Acute Care Surg. 2024 Apr 1;96(4):641-649. doi: 10.1097/TA.0000000000004121. Epub 2023 Aug 21.
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.
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.
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.
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.
Prognostic and Epidemiological; Level IV.
枪支暴力幸存者有严重的后遗症，包括再次遭受枪支伤害以及心理健康障碍，而这些问题往往未得到诊断和治疗。创伤筛查与认知及缓解工具（START）是一种针对有色人种社区中遭受持续创伤的患者开发的针对性行为心理健康干预措施。
在这项试点研究中，我们评估了完成一项随机对照试验以测试START干预措施的可行性。采用混合方法研究设计，我们使用定量和定性数据收集来评估START干预措施以及完成随机对照试验的可行性。本研究的目的是估计重要的研究参数，以便开展未来的随机对照试验。
我们能够就行为干预试验的几个关键领域得出结论：（1）招募与留存——我们的随访率很高，但招募率较低（符合条件的参与者中只有34%）；（2）干预措施的可接受性——增加视听资源会使工具更易于使用；（3）对照的可行性——更适合采用阶梯式楔形整群随机对照试验设计；（4）干预的保真度——保真度调查结果与录音之间的一致性率为81%；（5）近似效应大小——在第一个月，对照组的创伤后应激障碍检查表平民版得分下降了0.4分，而治疗组下降了10.7分。
虽然开展随机对照试验是可行的，但我们的研究结果表明，阶梯式楔形整群随机对照试验设计可能是START干预措施最成功的试验设计。此外，纳入“可信信使”以招募参与者加入研究以及为START开发视听资源将提高招募率和有效性。
预后与流行病学；四级。
