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:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05675020
Eligibility Criteria:
* Adolescents, 12-17 years old, with a clinical diagnosis of a mental health condition(s) and their parent/legal guardian.
* Examples of eligible diagnosed mental health conditions include major depressive disorder (MDD), generalized anxiety disorder (GAD), attention-deficit disorder (ADD)/ attention deficit hyperactivity disorder (ADHD), bipolar disorder (BPD).
* Adolescents that score below 13 on the World Health Organization (Five) Well-Being Index survey or if the adolescent has answered 0 to 1 to any of the five items, they will not be allowed to complete the REDCap survey or participate in the project unless they are currently enrolled in outpatient mental health services (Ex: counseling, therapy, partial hospitalization).
* Parent(s)/legal guardian(s), 18 years old or older, live with adolescents diagnosed with a mental health condition(s)
Inclusion Criteria:
* Individuals who are not yet adults (Adolescents 12-17 years old)
* With diagnosed mental health condition (ex: Depression, Anxiety, ADD/ADHD) more than one year ago.
* Adolescent eligibility determined with WHO-5 screening prior to pre-intervention survey. o Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental health condition(s)
* Be able to read/write in English
Exclusion Criteria:
* Children \<12 years old or \>18 years old
* Children 12-17 that are wards of the state or any other agency, institution, or entity
* Adolescent scoring \<13 and not currently enrolled in mental health services, or if the adolescent has answered 0 to 1 to any of the five items, on the WHO-5, and not currently enrolled in mental health services.
* Female participants that report they are pregnant before or after the start of the study will be excluded from the study.
* Parent(s)/legal guardian(s) \< 18 years old
* Non-legal guardians
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05675020
Study Brief:
Protocol Section:
NCT05675020