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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07402681
Acronym
EVOLVE
Enrollment
21
Registered
2026-02-11
Start date
2026-02-01
Completion date
2027-12-01
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Symptoms

Keywords

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

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).

Interventions

OTHERTrauma-focused Cognitive Behavioral Therapy for Children and Adolescents

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.

Sponsors

University Children's Hospital, Zurich
Lead SponsorOTHER
Otto-Friedrich-University Bamberg
CollaboratorOTHER
Catholic University of Eichstätt-Ingolstadt
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
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 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 1yearThe 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)

Secondary

MeasureTime frameDescription
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 yearsICD-11 single episode depressive disorder (self- and Caregiver-report); score range: 0 - 27; higher scores mean worse outcome.
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 yearsICD-11 generalised anxiety disorder (self- and caregiver-report); score range: 0 - 24; higher scores mean worse outcome.
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 yearsNegative trauma-related cognitions (self-report); ranges are from 25 to 100 for the total scale; higher scores indicate more dysfunctional trauma-related cognitions.
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 yearsPotentially traumatic events; DSM-5/ICD-11 post-traumatic stress symptoms (self- and caregiver-report); total score range: 0-60; higher scores mean worse outcome.
Functioning scale of the Ohio Scales Youth ScalesBaseline, 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 yearsLevel of daily functioning (self- and caregiver-report); score range: 0-80 higher scores mean better outcome.
Inventory for the assessment of Negative Effects of Psychotherapy for children and adolescentsPost-treatment, up to 1 yearUnwanted negative effects of psychotherapy (self- and caregiver-report); score range: 0-54; higher scores mean worse outcome.
Parental Acceptance Rejection Questionnaire (PARQ)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 yearsInterpersonal acceptance and rejection in the child-parent relationship (self- and caregiver-report); score range: 24-96; higher scores mean worse outcome.
Session Rating Scale (SRS)After every TF-CBT treatment session, up to 1 yearTherapeutic Relationship (self-report); score range: 0-40; higher scores mean better outcome.

Countries

Switzerland

Contacts

CONTACTLasse Bartels, PhD
lasse.bartels@kispi.uzh.ch+41 44 249 56 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026