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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT05376358
Eligibility Criteria:
Inclusion Criteria:
Adolescent:
* age 12 -18
* prior or present history of depression per self-report and/or clinician diagnosis
* scores between 5 or higher on PHQ-9 consistent with at least mild symptoms of depression
* read and understand English
* has an Android or iOS smartphone compatible with AWARE mobile application and access to a smartphone data plan
* currently in United States
Parent/Guardian:
* adolescent qualifies for study and assents to enroll
* understands English
* currently in United States
* has a smartphone device that can download the intervention application
Healthcare Provider:
\- involved in providing mental health treatment (psychotherapy or antidepressant prescribing or making referrals) to adolescent participant - can be a primary care provider, therapist, subspecialist, psychiatrist
Exclusion Criteria:
Adolescent:
* currently actively suicidal (have suicidal thoughts and plan with an intent to act on it)
* plans to travel to countries belonging to the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden), the United Kingdom (England, Scotland, Wales, and Northern Ireland), Norway, Iceland, or Lichtenstein in the next 6 months for more than 2 weeks at a time
Parent:
\- If their adolescent child is excluded
Healthcare Provider:
\- None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05376358
Study Brief:
Protocol Section:
NCT05376358