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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT06020261
Eligibility Criteria:
Inclusion Criteria:
* clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
* parent or guardian willing to participate in treatment with the child
Exclusion Criteria:
* psychiatric instability (danger to self/others, risky substance abuse)
* current active Post-Traumatic Stress Disorder (PTSD) or a severe active stressor (e.g. child abuse)
* history of severe psychopathology with an established alternate treatment (e.g. autism spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)
* general medical condition that may be driving irritability or prevent generalizable physiologic measures.
* screen positive for an intellectual disability via Wechsler Abbreviated Scale of Intelligence Second Edition (WASI II) estimated Intelligence Quotient (IQ)\<70.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
14 Years
Study:
NCT06020261
Study Brief:
Protocol Section:
NCT06020261