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NCT Number: NCT07296939

Youth Emotional and Behavioral Treatment Study

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32304, United States

Location status: Recruiting

Location contact

Harmon Youth Lab

CONTACT

[email protected]

8506458724

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherelle Harmon, PhD

CONTACT

[email protected]

18506458724

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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