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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT05686512
Eligibility Criteria:
Inclusion Criteria:
* The child is 7-12 years old. Confirmed by the caregiver and subsequently by the medical records.
* The child suffers from mild to moderate anxiety. The term "mild to moderate anxiety" has not been explicitly defined but is a term aimed to specify a demarcation between the FLMH and the psychiatric specialist services. Adequate level of care for the patient is decided based on an overall clinical assessment. The Children Global Assessment Scale (CGAS) is often used to guide the decision on level of care, where a CGAS value above 60 clearly indicates primary care services, a value below 50 clearly indicates specialist services. For values between 50 and 60 the overall clinical evaluation of symptom severity and impaired function guide the decision on level of care. Confirmed by the assessor at the FLMH-unit
Exclusion Criteria:
* Other psychiatric or developmental disorders than anxiety, or social issues that primarily require other interventions (i.e., where an intervention targeting mild to moderate anxiety is not adequate). Confirmed by assessor at the FLMH-unit.
* The child has another ongoing psychological intervention. An ongoing psychological treatment for any other psychiatric disorder. Confirmed by the caregiver.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT05686512
Study Brief:
Protocol Section:
NCT05686512