Depression, Anxiety
Conditions
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.
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
BEHAVIORALCognitive Behavioral Therapy
Participants will receive evidence-based treatment designed to address a wide range of emotional disorders.
Sponsors
Florida State University
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Standard evidence-based intervention based on child's primary diagnosis.
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions - Improvement Scale | 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). |
| Affective Reactivity Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Behavior Assessment System for Children | 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. |
| Stop-Signal | 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. |
| Global-Local | Baseline to post-treatment (up to 28 weeks) | Computerized task assessing set-shifting in youth participants; longer reaction times indicate poorer performance. |
| Letter Updating | Baseline to post-treatment (up to 28 weeks) | Computerized task assessing working memory updating in youth participants; higher scores indicate better updating abilities. |
Countries
United States
Contacts
CONTACTSherelle Harmon, PhD
Outcome results
None listed