CBITS - Treat Trauma in Child Welfare

NCT06038357 | Unknown DMC

• 1 other identifier: DFG PF 990/4-1 - AO 692822
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Posttraumatic Stress Disorder

Keywords

children; adolescents; PTSD; trauma-focused group intervention; randomized controlled trial; child welfare programs; CBITS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Revised Child Anxiety and Depression Scale (RCADS) (self-and caregiver report)

  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)

  baseline, 4-month follow-up, 10-month follow-up

• Child and Adolescent Trauma Screen - Second Version (CATS-2 caregiver-report)

  baseline, 4-month follow-up, 10-month follow-up

• Children's Global Assessment Scale (CGAS Caregiver-report)

  baseline, 4-month follow-up, 10-month follow-up

Other Outcomes (9)

• Non-standardized quantitative questionnaire to collect study feedback

  4-month follow-up, 10-month follow-up

• Non-standardized qualitative interview to collect study feedback

  4-month follow-up, 10-month follow-up

• Child and Adolescent Mental Health Service Receipt Inventory - German (CAMHSRI-German caregiver-report)

  baseline, 4-month follow-up, 10-month follow-up

Study Arms (2)

CBITS

EXPERIMENTAL

Cognitive Behavioral Intervention for Trauma in Schools (CBITS)

Behavioral: CBITS

Treatment as usual (TAU+)

ACTIVE COMPARATOR

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+

Interventions

CBITS BEHAVIORAL

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.

Also known as: Cognitive Behavioral Intervention for Trauma in Schools

CBITS

TAU+ OTHER

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.

Treatment as usual (TAU+)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Ulm: lead
• Ruhr University of Bochum: collaborator
• Philipps University Marburg: collaborator

Related Publications (8)

• Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.

  PMID: 35928521 BACKGROUND

• Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.

  PMID: 10937431 BACKGROUND

• Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.

  PMID: 6639293 BACKGROUND

• Waldmann T, Stiawa M, Dinc U, Saglam G, Busmann M, Daubmann A, Adema B, Wegscheider K, Wiegand-Grefe S, Kilian R. Costs of health and social services use in children of parents with mental illness. Child Adolesc Psychiatry Ment Health. 2021 Feb 20;15(1):10. doi: 10.1186/s13034-021-00360-y.

  PMID: 33610177 BACKGROUND

• Ehrhart MG, Aarons GA, Farahnak LR. Going above and beyond for implementation: the development and validity testing of the Implementation Citizenship Behavior Scale (ICBS). Implement Sci. 2015 May 7;10:65. doi: 10.1186/s13012-015-0255-8.

  PMID: 25948489 BACKGROUND

• Rye M, Torres EM, Friborg O, Skre I, Aarons GA. The Evidence-based Practice Attitude Scale-36 (EBPAS-36): a brief and pragmatic measure of attitudes to evidence-based practice validated in US and Norwegian samples. Implement Sci. 2017 Apr 4;12(1):44. doi: 10.1186/s13012-017-0573-0.

  PMID: 28372587 BACKGROUND

• Bieda A, Pflug V, Scholten S, Lippert MW, Ladwig I, Nestoriuc Y, Schneider S. [Unwanted Side Effects in Children and Youth Psychotherapy - Introduction and Recommendations]. Psychother Psychosom Med Psychol. 2018 Sep;68(9-10):383-390. doi: 10.1055/s-0044-102291. Epub 2018 May 30. German.

  PMID: 29847849 BACKGROUND

• Pfeiffer E, Dorrie L, Koksal J, Krech F, Muche R, Segler J, Sachser C. Evaluation of "Cognitive Behavioral Intervention for Trauma in Schools" (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial. Trials. 2024 Jun 19;25(1):399. doi: 10.1186/s13063-024-08190-x.

  PMID: 38898537 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Schools

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Elisa Pfeiffer, PhD

  Ulm University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Pfeiffer, PhD

CONTACT

+49 731 500 62658; CBITS.kjp@uniklinik-ulm.de

Cedric Sachser, PhD

CONTACT

+49 731 500 62659; CBITS.kjp@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Chief Psychologist)

Model Details: CBITS intervention vs. Treatment as Usual (TAU+)

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: September 14, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share