Youth Emotional and Behavioral Treatment Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation
Overview
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.
Detailed 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.
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)]
- Affective Reactivity Index [Time frame: Baseline to post-treatment (up to 28 weeks)]
Secondary outcome measures (4)
- Behavior Assessment System for Children [Time frame: Baseline to post-treatment (up to 28 weeks)]
- Stop-Signal [Time frame: Baseline to post-treatment (up to 28 weeks)]
- Global-Local [Time frame: Baseline to post-treatment (up to 28 weeks)]
- Letter Updating [Time frame: Baseline to post-treatment (up to 28 weeks)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Florida State University — Tallahassee
Identifiers
NCT: NCT07296939 · STUDY00005777 · U54CA267730