Youth Emotional and Behavioral Treatment Study

May 12, 2026 updated by: Sherelle Harmon, Florida State University

Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32304
        • Recruiting
        • Florida State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Behavioral: Cognitive Behavioral Therapy
Participants will receive evidence-based treatment designed to address a wide range of emotional disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Post-treatment (up to 28 weeks from baseline)
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.
Baseline to post-treatment (up to 28 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior Assessment System for Children
Time Frame: Baseline to post-treatment (up to 28 weeks)
Youth- and caregiver-reported measure of behavioral and emotional functioning; T-scores of 70 or higher indicate clinically significant symptoms.
Baseline to post-treatment (up to 28 weeks)
Stop-Signal
Time Frame: Baseline to post-treatment (up to 28 weeks)
Computerized task assessing inhibitory control in youth participants; longer stop-signal reaction times reflect slower inhibitory control.
Baseline to post-treatment (up to 28 weeks)
Global-Local
Time Frame: Baseline to post-treatment (up to 28 weeks)
Computerized task assessing set-shifting in youth participants; longer reaction times indicate poorer performance.
Baseline to post-treatment (up to 28 weeks)
Letter Updating
Time Frame: Baseline to post-treatment (up to 28 weeks)
Computerized task assessing working memory updating in youth participants; higher scores indicate better updating abilities.
Baseline to post-treatment (up to 28 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005777
  • U54CA267730 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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