Youth Emotional and Behavioral Treatment Study

NCT07296939 | Recruiting

• 2 other identifiers: STUDY00005777U54CA267730
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impressions - Improvement Scale

  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

  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 Outcomes (4)

• Behavior Assessment System for Children

  Baseline to post-treatment (up to 28 weeks)

• Stop-Signal

  Baseline to post-treatment (up to 28 weeks)

• Global-Local

  Baseline to post-treatment (up to 28 weeks)

• Letter Updating

  Baseline to post-treatment (up to 28 weeks)

Study Arms (1)

Treatment Group

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Participants will receive evidence-based treatment designed to address a wide range of emotional disorders.

Treatment Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sherelle Harmon, PhD

CONTACT

18506458724; harmonylab@psy.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Standard evidence-based intervention based on child's primary diagnosis.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-01

Locations

US (1)