Helping children and teens manage severe irritability, anxiety, and depression.
Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation
This program will try cognitive behavioral therapy plus detailed behavioral and brain tests to see if it helps children and teens (ages 4–17) with severe irritability, anxiety, or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07296939 on ClinicalTrials.gov |
What this trial studies
This project enrolls school-aged children (4–17) with anxiety or mood disorders or clinically impairing irritability to characterize mechanisms and deliver evidence-based treatment. Participants complete a comprehensive multimodal assessment including diagnostic interviews, multi-informant behavioral ratings, and neurophysiological tasks to capture cognitive, behavioral, and psychosocial factors. Participants then receive cognitive behavioral therapy with repeated assessments throughout the study period to measure changes. The design links mechanistic measurement with treatment response to identify targets that drive severe irritability.
Who should consider this trial
Good fit: Ideal candidates are English-speaking children aged 4–17 with a principal anxiety or mood disorder or clinically impairing irritability, with at least one parent available to participate.
Not a fit: Children with gross neurological or sensory impairments, seizure disorders, psychosis, active suicidality, or who cannot complete procedures in English are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could reduce severe irritability and improve daily functioning and mood in affected children.
How similar studies have performed: Cognitive behavioral therapy has proven effective for youth anxiety and depression, but applying a multimodal mechanistic assessment specifically to severe irritability is a newer, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children between the ages of 4-17 years * (a) a principal diagnosis of an anxiety or mood disorder per DSM-5 criteria, OR (b) parent report of clinically impairing irritability, emotional dysregulation, and/or disruptive behavior in youth * Child and parent must be able to complete consent documents, assessments, and participate in treatment in English without a translator * At least one parent must be available and willing to participant in both phases. Exclusion Criteria: * Gross neurological, sensory, or motor impairment * History of seizure disorder, psychosis, or organic brain syndrome * Conditions requiring acute intervention, e.g., active suicidality * Non-English speaking child or parent
Where this trial is running
Tallahassee, Florida
- Florida State University — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Sherelle Harmon, PhD
- Email: harmonylab@psy.fsu.edu
- Phone: 18506458724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.