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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorUniversity Children's Hospital, Zurich

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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)

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

Secondary outcomes

1

International Depression Questionnaire (IDQ)

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

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
2

International Anxiety Questionnaire (IAQ)

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

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
3

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.

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
4

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.

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

Other outcomes

Sponsors and contacts

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University Children's Hospital, Zurich

Lead sponsor

Otto-Friedrich-University Bamberg

Collaborator

Catholic University of Eichstätt-Ingolstadt

Collaborator