Recruiting NCT07402681
Evaluating Symptom Variations and Observing Longitudinal Individual Change Effects in TF-CBT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents.
- Who it may be relevant to
- Registry conditions: Post-traumatic Stress Symptoms. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Trauma-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.
Primary outcome measures
- 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]
Secondary outcome measures (8)
- 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]
- 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]
- 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]
- 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]
- 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]
- Inventory for the assessment of Negative Effects of Psychotherapy for children and adolescents [Time frame: Post-treatment, up to 1 year]
- 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]
- Session Rating Scale (SRS) [Time frame: After every TF-CBT treatment session, up to 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Switzerland · 1 center
- University Children's Hospital Zurich — Zurich
Identifiers
NCT: NCT07402681 · 2024-00903