Clinical trial NCT06038357: CBITS - Treat Trauma in Child Welfare
Official title: Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in Child Welfare Programs in Germany: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: children
adolescents
PTSD
trauma-focused group intervention
randomized controlled trial
child welfare programs
CBITS
Lead sponsor: University Hospital Ulm
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
name: Philipps University Marburg
First posted: 2023-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CBITS intervention vs. Treatment as Usual (TAU+)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. 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.
3. 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.
4. 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.
5. 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:

1. Current psychosis for safety reasons and in because in this case another intervention another intervention has priority (same explanation for 2-4).
2. severe harm to self or others
3. severe substance disorder
4. acute suicidality
5. 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.

Primary outcomes:
measure: Child and Adolescent Trauma Screen - Second Version (CATS-2 self-report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up (primary endpoint 4-months follow up)
Secondary outcomes:
measure: Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up
measure: Screening and Promotion of Children and Adolescents Health: A European Public Health Perspective (KIDSCREEN questionnaire) (self-and caregiver report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up
measure: Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up
measure: Children's Global Assessment Scale (CGAS Caregiver-report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up
Other outcomes:
measure: Non-standardized quantitative questionnaire to collect study feedback
timeFrame: 4-month follow-up, 10-month follow-up
measure: Non-standardized qualitative interview to collect study feedback
timeFrame: 4-month follow-up, 10-month follow-up
measure: Child and Adolescent Mental Health Service Receipt Inventory - German (CAMHSRI-German caregiver-report)
timeFrame: baseline, 4-month follow-up, 10-month follow-up
measure: Implementation Climate Scale (ICS Caregiver-report)
timeFrame: baseline
measure: Evidence-Based Practice Attitude Scale (EBPAS-36 Caregiver-report)
timeFrame: baseline
measure: CBITS original adherence and fidelity measure
timeFrame: through study completion, an average of 10 weeks
measure: Child and Adolescent Trauma Screen - Second and Short Version (CATS-2 self-report)
timeFrame: through study completion, an average of 10 weeks
measure: Therapeutic Alliance Scales for Children - Revised (TASC-r)
timeFrame: through study completion, an average of 10 weeks
measure: Inventory for the Assessment of Negative Effects of Psychotherapy for children and adolescents (Children-INEP) (self-and caregiver report)
timeFrame: 4-month follow-up, 10-month follow-up
Locations:
Study officials:
affiliation: Ulm University Hospital
name: Elisa Pfeiffer, PhD
role: PRINCIPAL_INVESTIGATOR
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