Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: A Randomized Controlled Trial

大量研究表明，与普通人群相比，儿童福利计划中的儿童和青少年报告的创伤事件更多。创伤相关疾病(创伤后应激障碍、抑郁、焦虑)的患病率明显更高，这使得针对这一弱势群体的创伤治疗特别有希望。由于几个结构和个人障碍，特别是缺乏受过创伤治疗培训的治疗师，只有少数儿童/青少年在儿童福利方案中得到以需求为导向的治疗。目前的(国际)国家指南推荐以创伤为重点的认知行为方法来治疗创伤后应激障碍症状的儿童和青少年。由于其科学性和广泛性，团体治疗“学校创伤认知行为干预(CBITS)”被特别推荐。手动团体治疗建立在循证(以创伤为重点)行为方法的基础上，由治疗师实施，包括6-8名参与者的10个小组会议。本研究旨在通过随机对照试验(RCT)评估CBITS组治疗(CBITS与常规治疗)在减少创伤后应激障碍症状方面的有效性，以及其在儿童福利计划中对儿童/青少年的可行性。三个研究中心(乌尔姆大学、波鸿鲁尔大学和马尔堡菲利普斯大学)的治疗师将接受治疗开发商的专门培训和监督。研究参与者将被招募到合作的儿童福利机构，并在纳入研究后由独立的流行病学研究所随机化。研究设计包括三个测量时间点(治疗前/治疗后、治疗后6个月)，以检验CBITS在主要结果(PTSD)和次要结果(焦虑、抑郁、生活质量、功能障碍、儿童福利退学)方面优于对照条件的假设。将对几个潜在的治疗过程变量(例如治疗联盟)进行探索性分析。这是第一项评估德国精神卫生系统中以创伤为重点的团体治疗的研究，通过实施外展方法弥合系统之间的差距，其中治疗师将在儿童福利环境中提供治疗。

A large body of research shows that children and adolescents in child welfare programs report more traumatic events compared with the general population. Prevalence rates of trauma-related disorders (PTSD, depression, anxiety) are significantly higher which makes trauma-focused treatments for this vulnerable population especially promising. Due to several structural and individual barriers, particularly the lack of therapists with training in trauma-focused treatments, only few children/ adolescents in child welfare programs receive a needs-oriented treatment. Current (inter-)national guidelines recommend trauma-focused cognitive behavioral approaches for treating traumatized children and adolescents with symptoms of PTSD. Due to its scientific evidence and broad dissemination, the group treatment “Cognitive Behavioral Intervention for Trauma in Schools (CBITS)” has been recommended in particular. The manualized group treatment builds on evidence-based (trauma-focused) behavioral methods, is implemented by therapists and comprises 10 group sessions with 6-8 participants. This study aims at evaluating the group treatment CBITS in a randomized controlled trial (RCT) (CBITS vs. treatment as usual) regarding its effectiveness in reducing PTSD symptoms as well as its feasibility for children/ adolescents in child welfare programs. Therapists in three study centers (University Ulm, Ruhr University Bochum, and Philipps-University Marburg) will be specifically trained and supervised by the treatment developers. Study participants will be recruited in collaborating child welfare institutions and randomized by an independent epidemiological institute after study inclusion. The study design comprises three measurement time points (before/ after treatment, 6-month post-treatment) in order to test the hypothesis of superiority of CBITS compared with the control condition on the primary outcome (PTSD) and secondary outcomes (anxiety, depression, quality of life, functional impairment, drop-out of child welfare). Exploratory analysis will be performed with several potential treatment process variables (e.g. therapeutic alliance). This is the first study evaluating a trauma-focused group treatment in the German mental health system, bridging the gap between systems by implementing an outreach approach in which the therapist will deliver the treatment within the child welfare setting.