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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT06239792
Eligibility Criteria:
Inclusion Criteria:
Youth:
* Able and willing to provide informed assent (with consent from parent/guardian)
* Ages 12-18
* Currently a patient at Kids Plus Pediatrics
* Currently depressed
* Report short sleep duration (\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \>=2 hours
Parents:
Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.
Exclusion Criteria:
Youth:
* Significant or unstable medical conditions
* Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
* Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
* Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
* Changes in medications in the month prior to screening
* Active suicidality requiring immediate treatment
* Unable or unwilling to comply with study procedures
* Have any physical or mental condition that would preclude study participation.
Parents will be excluded if they:
* Express active suicidality that requires immediate treatment;
* Have any physical or mental condition that would preclude study participation; OR
* Are unable or unwilling to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT06239792
Study Brief:
Protocol Section:
NCT06239792