Evaluating Symptom Variations and Observing Longitudinal Individual Change Effects in TF-CBT

NCT07402681 | Recruiting

• 1 other identifier: 2024-00903
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the level of change in post-traumatic stress symptoms in adolescents with traumatic experiences over the course of trauma-focused cognitive behavioral therapy for children and adolescents according to Cohen, Manarinno, \& Deblinger (2017).

Conditions

Post-traumatic Stress Symptoms

Keywords

TF-CBT; post-traumatic stress symptoms; single-case experimental design

Outcome Measures

Primary Outcomes (1)

• Short, semi-individually-tailored questionnaire - so-called Idiosyncratic Assessment (IA) - assessing the six ICD-11 PTSS plus six individually selected PTSS that are most distressing to the patient.

  The 12 symptoms are selected at the baseline assessment from the Child And Adolescent Trauma Screen 2 (Sachser et al., 2022). A Visual Analogue Scale is utilized the intensity of symptoms (0 = not at all - 100 = extreme)

  The IA will be assessed every two days four weeks before the start of TF-CBT treatment as well as every two days over the course of TF-CBT treatment; up to 1year

Secondary Outcomes (8)

• International Depression Questionnaire (IDQ)

  Baseline, pre-treatment, after TF-CBT stabilization and skills phase, after TF-CBT trauma narrative treatment phase, after TF-CBT cognitive restructuring-treatment phase, post-treatment, three-month follow-up; up to 1.5 years

• International Anxiety Questionnaire (IAQ)

  Baseline, pre-treatment, after TF-CBT stabilization and skills phase, after TF-CBT trauma narrative treatment phase, after TF-CBT cognitive restructuring-treatment phase, post-treatment, three-month follow-up; up to 1.5 years

• Child Post-Traumatic Cognitions Inventory (CPTCI)

  Baseline, pre-treatment, after TF-CBT stabilization and skills phase, after TF-CBT trauma narrative treatment phase, after TF-CBT cognitive restructuring-treatment phase, post-treatment, three-month follow-up, up to 1.5 years

• Child and Adolescent Trauma Screen 2 (CATS-2)

  Baseline, pre-treatment, after TF-CBT stabilization and skills phase, after TF-CBT trauma narrative treatment phase, after TF-CBT cognitive restructuring-treatment phase, post-treatment, three-month follow-up, up to 1.5 years

• Functioning scale of the Ohio Scales Youth Scales

  Baseline, pre-treatment, after TF-CBT stabilization and skills phase, after TF-CBT trauma narrative treatment phase, after TF-CBT cognitive restructuring-treatment phase, post-treatment, three-month follow-up, up to 1.5 years

Interventions

Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents OTHER

TF-CBT is a child and family-focused, component-based trauma-focused intervention that aims to address post-traumatic stress symptoms and other trauma-related difficulties (e.g., anxiety, depression) associated with traumatic events.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents between 12 and 18 years for whom trauma-focused treatment is indicated due to a PTE/ PTEs they have experienced as well as a significant level of PTSS.

Participants will be included if: 1. they are between 12 and 18 years of age; 2. they have been exposed to at least one or more traumatic event(s) according to the DSM-5 A criteria after the age of 3 years and dating back at least 1 months (with regard to the ability of patients to remember the event(s) and to the high spontaneous remissions of PTSS in the first month after a traumatic event); 3. they exhibit high severity of DSM-5 PTSS as indicated by a total symptom score of ≥25 assessed with the Child and Adolescent Trauma Screen 2 (CATS-2); 4. a nonoffending adult caregiver is available for the treatment and willing to participate in weekly treatment sessions (the inclusion of a caregiver is integral to the TF-CBT treatment model); 5. they are willing and able to attend weekly treatment sessions; 6. if their living circumstances are safe and stable to minimize the risk of re-traumatization during the project; 7. they and their caregiver have sufficient command of the German language (i.e., to participate in assessment \[read\] and treatment\[converse\]); 8. they and their caregivers possess a smartphone. 9. they and their caregiver provided written informed consent. Participants will not be included if: 1. they exhibit acute suicidal behavior or have suicidal ideations requiring immediate hospitalization; 2. they have a documented developmental disorder (i.e., autism spectrum disorder) or current psychosis based on adolescent- and caregiver-report and clinical assessment; 3. they exhibit severe substance misuse based on clinical assessment; 4. take part in concurrent psychotherapy during TF-CBT; 5. exhibit severe intellectual disability based on clinical assessment.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• Otto-Friedrich-University Bamberg: collaborator
• Catholic University of Eichstätt-Ingolstadt: collaborator

Study Sites (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Central Study Contacts

Lasse Bartels, PhD

CONTACT

+41 44 249 56 60; lasse.bartels@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CH (1)