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

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).

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Symptoms
• Intervention / Treatment: Other: Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents

• Study Type: Observational
• Enrollment (Estimated): 21

Contacts and Locations

• Study Contact: Name: Lasse Bartels, PhD; Phone Number: +41 44 249 56 60; Email: lasse.bartels@kispi.uzh.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8008
      • Recruiting
      • University Children's Hospital Zurich
      • Contact: Lasse Bartels, PhD; Phone Number: +41 44 249 56 60; Email: lasse.bartels@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Depression Questionnaire (IDQ)	ICD-11 single episode depressive disorder (self- and Caregiver-report); score range: 0 - 27; higher scores mean worse outcome.	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)	ICD-11 generalised anxiety disorder (self- and caregiver-report); score range: 0 - 24; higher scores mean worse outcome.	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)	Negative trauma-related cognitions (self-report); ranges are from 25 to 100 for the total scale; higher scores indicate more dysfunctional trauma-related cognitions.	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)	Potentially traumatic events; DSM-5/ICD-11 post-traumatic stress symptoms (self- and caregiver-report); total score range: 0-60; higher scores mean worse outcome.	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	Level of daily functioning (self- and caregiver-report); score range: 0-80 higher scores mean better outcome.	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
Inventory for the assessment of Negative Effects of Psychotherapy for children and adolescents	Unwanted negative effects of psychotherapy (self- and caregiver-report); score range: 0-54; higher scores mean worse outcome.	Post-treatment, up to 1 year
Parental Acceptance Rejection Questionnaire (PARQ)	Interpersonal acceptance and rejection in the child-parent relationship (self- and caregiver-report); score range: 24-96; higher scores mean worse outcome.	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
Session Rating Scale (SRS)	Therapeutic Relationship (self-report); score range: 0-40; higher scores mean better outcome.	After every TF-CBT treatment session, up to 1 year

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: Otto-Friedrich-University Bamberg; Catholic University of Eichstätt-Ingolstadt

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: TF-CBT; single-case experimental design; post-traumatic stress symptoms
• Other Study ID Numbers: 2024-00903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No