NCT07296939 · Florida State University
Youth Emotional and Behavioral Treatment Study
What this study is about
This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.
View original scientific description
This study aims to characterize key mechanisms underlying the development, maintenance, and treatment of severe irritability in a clinically heterogeneous sample of school-aged youth.
Interventions
BEHAVIORAL
Cognitive Behavioral Therapy
Participants will receive evidence-based treatment designed to address a wide range of emotional disorders.
Primary outcome measures
Clinical Global Impressions - Improvement Scale
Time frame: Post-treatment (up to 28 weeks from baseline)
Clinician-rated assessment of overall clinical change, with scores ranging from 1 (very much improved) to 7 (very much worse).
Affective Reactivity Index
Time frame: Baseline to post-treatment (up to 28 weeks)
Youth- and caregiver-reported measure of irritability, with total scores ranging from 0 to 12; higher scores indicate greater symptom severity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Tallahassee, Florida
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations