CBITS - Treat Trauma in Child Welfare

Study Overview
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Brief Summary
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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
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The study objectives are 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 Investigate potential long-term effects of the treatment in the CBITS condition regarding the primary and secondary outcomes at 10-month follow-up. 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. 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.

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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: CBITS
* Other: TAU+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 8-16 years, because this age range reflects the age range in the CBITS evaluation studies, and this age range is specified in the CBITS manual and toolkit). Having experienced at least one traumatic event (based on DSM-5 or ICD-10/ICD-11 criteria) as CBITS is designed for children and adolescents with a trauma history. At least moderate PTSS (at least 21 points on the CATS-2) as this is recommended in the intervention manual. Participants don't have to fulfill PTSD criteria as the manual does not name this a pre-condition for participation. Additionally, there is large evidence that also youth with subthreshold PTSS show high functional impairment, but respond very well to trauma-focused interventions. Being currently cared for by a child welfare program (safe and stable living conditions), planned further stay in the program for at least 12 months in order to complete the CBITS intervention and 10-month follow-up. Willingness and informed assent/consent of the participant as well as informed consent of the caregiver/legal guardian to participate in the study (sufficient motivation for group intervention and compliance with the study design). Exclusion Criteria: Current psychosis for safety reasons and in because in this case another intervention another intervention has priority (same explanation for 2-4). severe harm to self or others severe substance disorder acute suicidality Severe mental retardation as there is a certain necessity of sufficient cognitive abilities to benefit from CBITS, to recall trauma memories and to create a trauma narrative.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CBITS intervention vs. Treatment as Usual (TAU+)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBITS<br>Cognitive Behavioral Intervention for Trauma in Schools (CBITS) | Behavioral: CBITS<br>* 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.<br>* Other names: Cognitive Behavioral Intervention for Trauma in Schools;|
| Active Comparator: Treatment as usual (TAU+)<br>Enhanced Treatment as Usual means regular care in child welfare program and mental health care. They also receive feedback on their assessments and a treatment recommendation. | Other: TAU+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report) | The CATS-2 is a questionnaire to screen for potentially traumatic events and assesses symptoms of PTSD/Complex-PTSD (CPTSD) (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and International Classification of Diseases Version 11 (ICD-11)) in children and adolescents. The minimal score value is 0, the maximum score value is 60, while higher scores mean a worse outcome. | baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report) | The RCADS is a 47-item, self- and caregiver-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). For the anxiety subscale the minimum score value is 0, the maximum score value is 111, while higher scores mean more anxiety. For the depression subscale the minimum score value is 0, the maximum score value is 30, while higher scores mean worse depressive symptoms. Therefore, the minimum score value is 0, the maximum score value is 141, while higher scores mean a worse outcome. | baseline, 4-month follow-up, 10-month follow-up | 
| Screening and Promotion of Children and Adolescents Health: A European Public Health Perspective (KIDSCREEN questionnaire) (self-and caregiver report) | Quality of life will be assessed via the KIDSCREEN-10 which is a generic health related quality of life measure. The minimum score value is 10, the maximum score value is 50, while higher scores mean a better quality of life. | baseline, 4-month follow-up, 10-month follow-up | 
| Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report) | corresponding measure to CATS-2 self-report, completed by the participants' caregivers. The minimum score value is 0, the maximum score value is 60, while higher scores mean a worse outcome. | baseline, 4-month follow-up, 10-month follow-up | 
| Children's Global Assessment Scale (CGAS Caregiver-report) | The level of functioning will be assessed via the CGAS. The minimum score value is 1, the maximum score value is 100, while higher scores mean a higher functioning level. | baseline, 4-month follow-up, 10-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, adolescents, PTSD, trauma-focused group intervention, randomized controlled trial, child welfare programs, CBITS