Post-traumatic Stress SymptomsEVOLVENCT07402681
Evaluating Symptom Variations and Observing Longitudinal Individual Change Effects in TF-CBT
An observational study of Post-traumatic Stress Symptoms, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Post-traumatic Stress Symptoms
- What is being tested?
- Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8008
Lasse Bartels, PhD, +41 44 249 56 60, lasse.bartels@kispi.uzh.ch
About this study
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).
- Conditions
- Post-traumatic Stress Symptoms
- Being tested
- Trauma-focused Cognitive Behavioral Therapy for Children and Adolescents
- Keywords
- TF-CBT, post-traumatic stress symptoms, single-case experimental design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused Cognitive Behavioral Therapy for Children and AdolescentsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 (8)
International Depression Questionnaire (IDQ)
ICD-11 single episode depressive disorder (self- and Caregiver-report); score range: 0 - 27; higher scores mean worse outcome.
Measured: 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)
ICD-11 generalised anxiety disorder (self- and caregiver-report); score range: 0 - 24; higher scores mean worse outcome.
Measured: 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)
Negative trauma-related cognitions (self-report); ranges are from 25 to 100 for the total scale; higher scores indicate more dysfunctional trauma-related cognitions.
Measured: 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)
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.
Measured: 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
Level of daily functioning (self- and caregiver-report); score range: 0-80 higher scores mean better outcome.
Measured: 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
Unwanted negative effects of psychotherapy (self- and caregiver-report); score range: 0-54; higher scores mean worse outcome.
Measured: Post-treatment, up to 1 year
Parental Acceptance Rejection Questionnaire (PARQ)
Interpersonal acceptance and rejection in the child-parent relationship (self- and caregiver-report); score range: 24-96; higher scores mean worse outcome.
Measured: 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)
Therapeutic Relationship (self-report); score range: 0-40; higher scores mean better outcome.
Measured: After every TF-CBT treatment session, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Otto-Friedrich-University Bamberg, Catholic University of Eichstätt-Ingolstadt
- Responsible party
- Principal investigator, Lasse Bartels, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402681
- Sponsor's protocol ID
- 2024-00903
- Acronym
- EVOLVE
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Symptom Variations and Observing Longitudinal Individual Change Effects in TF-CBT
- ClinicalTrials.gov ID
- NCT07402681
- Acronym / sponsor ID
- EVOLVE / 2024-00903
- Conditions
- Post-traumatic Stress Symptoms
- Keywords
- TF-CBT, post-traumatic stress symptoms, single-case experimental design
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Otto-Friedrich-University Bamberg, Catholic University of Eichstätt-Ingolstadt
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-focused Cognitive Behavioral Therapy for Children and AdolescentsTF-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. | Other | – |
Primary outcome
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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Symptoms, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lasse Bartels, PhD (+41 44 249 56 60, lasse.bartels@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.