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

德国儿童福利项目中“学校创伤认知行为干预”（CBITS）的评估：随机对照试验

• 批准号: 514610031
• 负责人: Dr. Elisa Maria Pfeiffer, Ph.D.
• 金额: --
• 依托单位: Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/514610031?language=en
• 关键词: Evaluation; Cognitive; Behavioral; Intervention; Trauma

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.

大量研究表明，与一般人群相比，儿童福利项目中的儿童和青少年报告了更多的创伤性事件。创伤相关疾病（创伤后应激障碍、抑郁、焦虑）的患病率明显较高，这使得针对这一弱势群体的创伤治疗尤其有希望。由于一些结构性和个人障碍，特别是缺乏受过创伤治疗培训的治疗师，只有少数儿童/青少年在儿童福利项目中接受以需求为导向的治疗。目前（国际）国家指南推荐以创伤为重点的认知行为方法来治疗有创伤后应激障碍症状的创伤儿童和青少年。由于其科学依据和广泛传播，“学校创伤认知行为干预（CBITS）”小组治疗被特别推荐。手动小组治疗建立在以证据为基础（以创伤为重点）的行为方法上，由治疗师实施，包括10个小组会议，每组6-8名参与者。本研究旨在通过一项随机对照试验（RCT）评估CBITS组治疗（CBITS vs.常规治疗）在减轻创伤后应激障碍症状方面的有效性及其在儿童福利项目中对儿童/青少年的可行性。三个研究中心（乌尔姆大学、波洪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人员的专门培训和监督。研究参与者将在合作儿童福利机构中招募，并在纳入研究后由独立的流行病学研究所随机分配。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在主要结局（PTSD）和次要结局（焦虑、抑郁、生活质量、功能障碍、退出儿童福利）方面优于对照组的假设。探索性分析将对几个潜在的治疗过程变量（如治疗联盟）进行。这是第一个评估德国精神卫生系统中以创伤为中心的小组治疗的研究，通过实施治疗师在儿童福利环境中提供治疗的外展方法，弥合了系统之间的差距。