NCT06038357

CBITS - Treat Trauma in Child Welfare

Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital Ulm · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of the trauma-focused group intervention CBITS compared with enhanced treatment as usual (TAU+) in child welfare programs in Germany. The target group are traumatized children and adolescents in out-of-home care who report posttraumatic stress symptoms (PTSS).

Detailed description

The study objectives are 1. Evaluate the effectiveness of CBITS compared to TAU+ regarding PTSS symptom reduction (primary outcome), anxiety, depression, quality of life and functional level, and continuance of the child welfare program (secondary outcomes) at 4-month follow-up 2. Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up. 3. Implement CBITS as an outreach intervention into routine mental health care for traumatized children, to evaluate treatment fidelity, treatment completion and investigate different potential individual or structural factors that might have an impact on the implementation. 4. To assess the readiness in child welfare programs to collaborate with mental health services and the role of institutional environments for developmental trajectories. Participants and their caregivers will complete questionnaires at three measurement time points. Weekly PTSS symptom monitoring during treatment and alliance ratings (participants and therapists) at the beginning and the end of the intervention will be implemented. Trained therapists at three study centers (Marburg, Ulm, Bochum) will complete questionnaires before their training and after CBITS implementation. Site monitoring and auditing, as well as reliability checks of the data will be conducted by an independent data manager. Randomization will be implemented by an independent Institute at Ulm University. Standard Operating Procedures (SOPs) to address patient recruitment, data collection, data management, reporting for adverse events, and change management will be provided. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect were performed via the program G-Power, in collaboration with an independent statistical advisor, before proposal submission. A plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results are prepared in collaboration with the independent statistical advisor. We will following Intention-to-treat (ITT) principles in our analyses. The statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, are specified in the study protocol which will be published before data collection.

Conditions

• Posttraumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	CBITS	The CBITS program is a skills-based group and individual intervention, which uses evidence-based cognitive-behavioral techniques (e.g. psychoeducation, relaxation, social problem solving, cognitive restructuring, and exposure) and is designed for delivery by mental health professionals. The program consists of 10 45-minute group sessions (about 6-8 students/participants per group), 1-3 individual sessions, 2 parent/caregiver psychoeducational sessions, and 1 teacher/ child welfare staff educational session. For this study, we will specifically train and supervise study therapists to deliver the intervention within child welfare programs.
OTHER	TAU+	In the control condition (TAU+), child welfare programs will follow their usual procedures (i.e. routine care of child welfare, referral to medical practitioners and psychotherapists, handling of prescribed medication, referral to inpatient treatments in case of risk to self and others) which reflects treatment as usual in child welfare programs and the mental health care system in Germany. Additionally, participants in the control condition will receive the same baseline assessment and reporting of screening results as participants in the treatment condition after each assessment.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2023-09-14
• Last updated: 2023-09-14