Clinic for Child and Adolescent Psychiatry/Psychotherapy, Ulm University, Steinhoevelstr. 1, 89075, Ulm, Germany.
Institute of Epidemiology and Medical Biometry, Ulm University, Schwabstr. 13, 89075, Ulm, Germany.
Trials. 2024 Jun 19;25(1):399. doi: 10.1186/s13063-024-08190-x.
Children and adolescents growing up in child welfare institutions have been frequently exposed to traumatic events and psychosocial stress and show elevated rates of mental disorders. Yet, there is a lack of empirically supported treatments to provide adequate mental health care for children in care suffering from trauma-related mental disorders such as posttraumatic stress disorder (PTSD), depression, and anxiety. The Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is an evaluated trauma-focused cognitive-behavioral group intervention, which has proven to be effective in reducing symptoms of PTSD, depression, and anxiety for traumatized children in group settings. The trial will evaluate the effectiveness of the CBITS intervention as an outreach treatment compared with an enhanced treatment-as-usual condition (TAU +) within the German mental health and child welfare system.
In a randomized controlled trial (RCT) involving N = 90 children and adolescents, we will compare CBITS with TAU + . Participants between 8 and 16 years, reporting at least one traumatic event and moderate posttraumatic stress symptoms (PTSS), will be randomized within their child welfare institution to either one of the conditions using a CATS-2 severity-stratified block randomization. Assessments will take place at baseline, as well as 4 months and 10 months after baseline. The primary outcome is the severity of PTSS after 4 months. Secondary outcomes are depression, anxiety, irritability/anger, quality of life, and global functioning level.
The results of our trial will provide evidence regarding effective treatment options for traumatized children in care, which represent an understudied population with limited access to mental health care. Additionally, it could serve as a blueprint for implementing trauma-focused outreach group treatments for children in care and increase the accessibility to appropriate treatment.
Clinical Trials.gov NCT06038357 D. September 13, 2023.
在儿童福利院中成长的儿童和青少年经常遭受创伤事件和心理社会压力，其精神障碍发生率较高。然而，对于因创伤相关精神障碍（如创伤后应激障碍、抑郁和焦虑）而在福利院中遭受痛苦的儿童，缺乏经过实证支持的治疗方法来提供足够的心理健康护理。学校创伤认知行为干预（CBITS）是一种经过评估的创伤焦点认知行为小组干预，已被证明可有效减少创伤后儿童在小组环境中创伤后应激障碍、抑郁和焦虑的症状。该试验将评估 CBITS 干预作为拓展治疗与德国心理健康和儿童福利系统中的增强治疗即常规（TAU+）相比的有效性。
在一项涉及 90 名儿童和青少年的随机对照试验（RCT）中，我们将 CBITS 与 TAU+进行比较。参与者年龄在 8 至 16 岁之间，报告至少有一次创伤事件和中度创伤后应激症状（PTSS），将在其儿童福利院中根据 CATS-2 严重程度分层块随机分配到其中一种条件。评估将在基线时以及基线后 4 个月和 10 个月进行。主要结局是 4 个月后的 PTSS 严重程度。次要结局是抑郁、焦虑、易怒/愤怒、生活质量和整体功能水平。
我们试验的结果将为受创伤的福利院儿童提供有效的治疗选择证据，这些儿童是一个研究不足的群体，获得心理健康护理的机会有限。此外，它可以作为为福利院儿童实施创伤焦点拓展小组治疗的蓝图，并增加获得适当治疗的机会。
ClinicalTrials.gov NCT06038357，D. 2023 年 9 月 13 日。
