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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT05930535
Eligibility Criteria:
Inclusion Criteria:
1. for Caregivers:
* Age 18 or older at baseline assessment;
* Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household at least four nights a week in the previous month;
* Able to speak at least one of the local languages in which the program will be offered (Romanian, Russian, Macedonian)
* Agreement to participate in the program;
* Provision of consent for self and child to participate in the study.
2. for Adolescents:
* Age 10-14 at baseline assessment;
* Assent to participate in the study;
* Caregiver consent to participate in the study.
Exclusion Criteria:
No formal exclusion criteria have been set for FLOURISH. However, during the process of introducing the project, the research team will guide the participants through a consent form that asks whether they are currently experiencing acute distress or a mental health or physical health condition that would interfere with their participation. The judgement will be made by the potential participant. If the participant decides they are not currently able to take part due to acute health issues, the research team will follow up and provide referrals for other services.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
14 Years
Study:
NCT05930535
Study Brief:
Protocol Section:
NCT05930535