Recruiting

Observational Study

Sponsor:

Florida State University

Code:

NCT07296939

Conditions

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Study Details

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

Study ID

NCT07296939

Start date

May 7, 2026

Status verified date

Jan, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Interventions

Cognitive Behavioral Therapy

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Sherelle Harmon, PhD

18506458724harmonylab@psy.fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32304

Contacts

Harmon Youth Lab

8506458724harmonylab@psy.fsu.edu

More Information

Sponsor

Florida State University

Last update posted

May 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-05-14.