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

Abstract Background Children and adolescents growing up in child welfare institutions have been frequently exposed to traumatic events, 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 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. Methods In a randomized controlled trial (RCT) involving N = 90 children and adolescents, we will compare CBITS with TAU+. Participants between 8–16 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. Discussion 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 blueprint for implementing trauma-focused outreach group treatments for children in care and increase the accessibility to appropriate treatment. Trial registration Clinical Trials.gov, ID: NCT06038357 D. Registered on ClinicalTrials.gov public website. URL: https://classic.clinicaltrials.gov/ct2/show/NCT06038357?cond=NCT06038357&draw=2&rank=1