Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT05984706
Eligibility Criteria:
Inclusion Criteria:
The same inclusion criteria apply for the focus group discussions and for the Delphi process.
For children and adolescents:
* Children and adolescents, who experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) must have occurred after the fourth birthday.
* The PTE(s) must have occurred at least 1 month ago.
* Children and adolescents must be 7-18 years of age.
* Children and adolescents are either in trauma-focused treatment at the time of recruitment or they present with at least a moderate PTSS severity according to the Child and Adolescents Trauma Screen 2 (CATS-2) Self-report.
* Children and adolescents must have sufficient command of the German language, excluding a small group of 4-5 unaccompanied refugee adolescents who will also be included. This group will be assisted by an interpreter.
* The children and adolescents do not have any physical impairment due to injuries or somatic illnesses (self-assessment).
* The children and adolescents are not acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
For caregivers:
* Caregivers of children and adolescents, who experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) must have occurred at least 1 month ago.
* The child or adolescent must be between 1-18 years of age.
* Children and adolescents are either in trauma-focused therapy at the time of recruitment or they present with at least a moderate PTSS severity according to the Child and Adolescents Trauma Screen 2 (CATS-2).
* Caregivers must have sufficient command of the German language.
* The children and adolescents do not have any physical impairment due to injuries or somatic illnesses (self-assessment).
* The children and adolescents are not acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
For clinical experts:
* Clinician or researcher specialized in trauma and PTSD in children and adolescents.
* Clinical experts must have sufficient command of the English language.
Exclusion Criteria:
* For children and adolescent participants:
* Children and Adolescents who have not experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) occurred before the fourth birthday.
* The PTE(s) occurred less than 1 month ago.
* Children and adolescents that are younger than 7 years old and older than 18 years old.
* Children and adolescents that are neither in trauma-focused therapy at the time of recruitment nor meet the CATS-2 score for moderate PTSS severity or higher.
* Children and adolescents that do not have sufficient command of the German language.
* Children and adolescents that have physical impairment due to injuries or somatic illnesses (self-assessment).
* Children and adolescents that are acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
For caregivers:
* Caregivers of children or adolescents who have not experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) occurred less than 1 month ago.
* The child or adolescent is younger than 1 year old or older than 18 years old.
* The child or adolescent is neither in trauma-focused therapy at the time of recruitment nor meets the CATS-2 score for moderate PTSS severity or higher.
* Caregivers that do not have sufficient command of the German language.
* Children and adolescents that have physical impairment due to injuries or somatic illnesses (self-assessment).
* Children and adolescents that are acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
For clinical experts:
* Clinical experts that don't work as clinician or as researcher specialized in trauma and PTSD in children and adolescents.
* Clinical experts that do not have sufficient command of the English language.
All the participants' informed consent must be obtained before any data is collected.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT05984706
Study Brief:
Protocol Section:
NCT05984706