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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT05128669
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria for registration:
* Age 3 to 8
* Sufficiently stable psychosocial situation of the child for potential participation in the study
* Written informed consent of the patient's parents or legal guardian
* Informed oral consent of children (from 6 years)
* Release from professional secrecy Teacher / educator
* Positive pre-screening for internalizing symptoms
* Inclusion criteria for randomisation:
* Confirmation that the child's psychosocial situation is sufficiently stable to participate in the study
* physical/emotional neglect
* DSM-5 internalizing disorder
Exclusion Criteria:
* Exclusion criteria for registration:
* limited language skills of children or caregivers (caregiver: if communication severely impeded despite translators)
* unresolved custody dispute
* concurrent intensive psychotherapy of \>3 months duration
* participation of the child in other interventional trials
* Exclusion criteria for randomisation:
* IQ \< 70
* autism or psychosis/schizophrenia spectrum disorder of the child
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
8 Years
Study:
NCT05128669
Study Brief:
Protocol Section:
NCT05128669