Abstract：
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.
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.
METHODS: Prognostic and Epidemiological; Level IV.
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.
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.
METHODS: Prognostic and Epidemiological; Level IV.
摘要：
背景：枪支暴力的幸存者有严重的后遗症，包括枪支再次伤害和精神健康障碍，这些疾病往往得不到诊断和治疗。创伤意识和救济的筛查和工具（START）是一种有针对性的行为心理健康干预措施，适用于患有持续和持续创伤的有色人种社区患者。
方法：在这项试点研究中，我们评估了完成一项随机对照试验以检验START干预的可行性.使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.这项研究的目的是估计重要的研究参数，以便将来进行随机对照试验。
结果：我们能够得出关于行为干预试验几个关键领域的结论。（1）招聘和保留：我们的跟进率很高，但我们的招募率很低(34%的合格参与者)。（2）干预措施的可接受性：视听资源的增加将使工具更容易获得。(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）干预保真度：保真度调查结果与录音之间的一致率为81％。(5)近似效应大小:在第一个月,与治疗组下降10.7点相比,对照组的PCL-C下降0.4点。
结论：虽然进行随机对照试验是可行的，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干预最成功的试验设计.此外,纳入“可信信使”招募参与者加入研究，以及为START开发视听资源将提高招聘和效力。
方法：二级研究类型：原始研究。
方法：在这项试点研究中，我们评估了完成一项随机对照试验以检验START干预的可行性.使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.这项研究的目的是估计重要的研究参数，以便将来进行随机对照试验。
结果：我们能够得出关于行为干预试验几个关键领域的结论。（1）招聘和保留：我们的跟进率很高，但我们的招募率很低(34%的合格参与者)。（2）干预措施的可接受性：视听资源的增加将使工具更容易获得。(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）干预保真度：保真度调查结果与录音之间的一致率为81％。(5)近似效应大小:在第一个月,与治疗组下降10.7点相比,对照组的PCL-C下降0.4点。
结论：虽然进行随机对照试验是可行的，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干预最成功的试验设计.此外,纳入“可信信使”招募参与者加入研究，以及为START开发视听资源将提高招聘和效力。
方法：二级研究类型：原始研究。
