Youth Emotional and Behavioral Treatment Study

Florida State University

Status: Enrolling

Conditions: Depression, Anxiety

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07296939

U54CA267730 (U.S. NIH Grant/Contract)

STUDY00005777

Details and patient eligibility

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.

Full description

Severe irritability in youth is associated with significant functional impairment and occurs across diagnostic categories. 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. Participants will complete (a) a comprehensive, multimodal assessment - including diagnostic interviews, multi-informant behavioral ratings, and neurophysiological tasks - to evaluate core cognitive, behavioral, and psychosocial factors, and (b) evidence-based treatment (e.g., cognitive behavioral therapy). Repeated assessments throughout the study period will be used to evaluate study outcomes.

Enrollment: 500 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Treatment Group

Experimental group

Treatment:

Behavioral: Cognitive Behavioral Therapy