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NCT Number: NCT07402681

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

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).

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Key information

Conditions

Post-traumatic Stress Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8008, Switzerland

Location status: Recruiting

Location contact

Lasse Bartels, PhD

CONTACT

[email protected]

+41 44 249 56 60

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participants will be included if:

  • they are between 12 and 18 years of age;
  • 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);
  • 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);
  • 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);
  • they are willing and able to attend weekly treatment sessions;
  • if their living circumstances are safe and stable to minimize the risk of re-traumatization during the project;
  • they and their caregiver have sufficient command of the German language (i.e., to participate in assessment [read] and treatment[converse]);
  • they and their caregivers possess a smartphone.
  • they and their caregiver provided written informed consent.

Participants will not be included if:

  • they exhibit acute suicidal behavior or have suicidal ideations requiring immediate hospitalization;
  • they have a documented developmental disorder (i.e., autism spectrum disorder) or current psychosis based on adolescent- and caregiver-report and clinical assessment;
  • they exhibit severe substance misuse based on clinical assessment;
  • take part in concurrent psychotherapy during TF-CBT;
  • exhibit severe intellectual disability based on clinical assessment.

Treatment and study plan

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.

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.

    Time frame: 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

    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)

Secondary outcomes

  1. International Depression Questionnaire (IDQ)

    Time frame: 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

    ICD-11 single episode depressive disorder (self- and Caregiver-report); score range: 0 - 27; higher scores mean worse outcome.

  2. International Anxiety Questionnaire (IAQ)

    Time frame: 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

    ICD-11 generalised anxiety disorder (self- and caregiver-report); score range: 0 - 24; higher scores mean worse outcome.

  3. Child Post-Traumatic Cognitions Inventory (CPTCI)

    Time frame: 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

    Negative trauma-related cognitions (self-report); ranges are from 25 to 100 for the total scale; higher scores indicate more dysfunctional trauma-related cognitions.

  4. Child and Adolescent Trauma Screen 2 (CATS-2)

    Time frame: 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

    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.

  5. Functioning scale of the Ohio Scales Youth Scales

    Time frame: 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

    Level of daily functioning (self- and caregiver-report); score range: 0-80 higher scores mean better outcome.

  6. Inventory for the assessment of Negative Effects of Psychotherapy for children and adolescents

    Time frame: Post-treatment, up to 1 year

    Unwanted negative effects of psychotherapy (self- and caregiver-report); score range: 0-54; higher scores mean worse outcome.

  7. Parental Acceptance Rejection Questionnaire (PARQ)

    Time frame: 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

    Interpersonal acceptance and rejection in the child-parent relationship (self- and caregiver-report); score range: 24-96; higher scores mean worse outcome.

  8. Session Rating Scale (SRS)

    Time frame: After every TF-CBT treatment session, up to 1 year

    Therapeutic Relationship (self-report); score range: 0-40; higher scores mean better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Lasse Bartels, PhD

CONTACT

[email protected]

+41 44 249 56 60

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • Catholic University of Eichstätt-Ingolstadt
  • Otto-Friedrich-University Bamberg

Registry information

Acronym: EVOLVE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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