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

Обзор

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).

Вмешательства

• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: 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]

Вторичные конечные точки (8)

• International Depression Questionnaire (IDQ) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Post-treatment, up to 1 year]
• Parental Acceptance Rejection Questionnaire (PARQ) [Срок оценки: 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) [Срок оценки: After every TF-CBT treatment session, up to 1 year]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Швейцария · 1 центр

• University Children's Hospital Zurich — Zurich

Идентификаторы

NCT: NCT07402681 · 2024-00903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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