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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT03633903
Eligibility Criteria:
Inclusion Criteria:
* Age 13.00 to 15.99 years at time of baseline assessment
* Able to validly and safely complete baseline assessments
* All genders
* All races
* Eligibility as a subject with early life stress will be determined by:
* Scoring 4 or greater on Adverse Childhood Experiences (ACE) scale, with at least two experiences having occurred prior to age 10.
Exclusion Criteria:
* No biological parent or legal guardian identified to give permission for minor to participate
* History of neurological disorders including seizure disorder, cerebral palsy, or other conditions requiring neurological or medical care, being managed for migraines (e.g., daily prophylactic medication, seeing a neurologist for migraines), or a diagnosis of Developmental Delay, including severe learning disorder, mental retardation, pervasive developmental disorder, or other conditions requiring repeated and persistent specialized education.
* Current psychotic disorder, bipolar disorder, obsessive-compulsive and related disorders, substance use disorder, or conduct disorder.
* Current active suicidal ideation.
* Current use of medications with major effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); ADHD medications and SSRIs, that have been stable for at least 6 weeks, are not exclusionary since their use is associated with conditions that confer risk for monitored disorders that emerge in adolescence, and assessment of these individuals will provide useful data to the scientific community. Youth on ADHD medications and SSRIs will not be asked to go off their medications.
* Not fluent in English
* Non-correctable vision, hearing or sensorimotor impairments, as protocol elements may not be valid.
* Youth planning to move to an area not within reasonable traveling distance of LIBR; knowledge at baseline that treatment completion / follow-up will not be possible.
* Youth appears to be high/intoxicated, or withdrawing from the effects of alcohol or drugs at time of enrollment.
* Youth / parent who are unable or unwilling to provide biological samples (i.e., blood draws or saliva collection).
* Female youth who are pregnant
* Youth who are currently in unsafe environments (e.g., currently living with an abusive parent)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
15 Years
Study:
NCT03633903
Study Brief:
Protocol Section:
NCT03633903