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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT05697627
Eligibility Criteria:
Inclusion criteria:
1. Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
2. Males and females (age 9 - 17.99)
3. Participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of Michigan, if not already accessible to participant).
4. Self-reported depressive symptoms (Children's Depression Inventory \[CDI\] score between 3-19 at Assessment 1)
5. Participants will be required to maintain a stable dose of medications
EXCLUSION CRITERIA
1. Color blindness
2. Unable to play the video game for any reason
3. Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
4. Has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment
5. Endorses items #1, #2, #3, #4, #5, or #6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screener (Past-Month); i.e., has present suicidal intention/behavior.
6. Has had any changes to their medication in the 4-weeks prior to study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT05697627
Study Brief:
Protocol Section:
NCT05697627