Youth Emotional and Behavioral Treatment Study
ConditionDepression, Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralParticipants will receive evidence-based treatment designed to address a wide range of emotional disorders.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Post-treatment (up to 28 weeks from baseline)2
Affective Reactivity Index
Youth- and caregiver-reported measure of irritability, with total scores ranging from 0 to 12; higher scores indicate greater symptom severity.
Time frame
Baseline to post-treatment (up to 28 weeks)Secondary outcomes
1
Behavior Assessment System for Children
Youth- and caregiver-reported measure of behavioral and emotional functioning; T-scores of 70 or higher indicate clinically significant symptoms.
Time frame
Baseline to post-treatment (up to 28 weeks)2
Stop-Signal
Computerized task assessing inhibitory control in youth participants; longer stop-signal reaction times reflect slower inhibitory control.
Time frame
Baseline to post-treatment (up to 28 weeks)3
Global-Local
Computerized task assessing set-shifting in youth participants; longer reaction times indicate poorer performance.
Time frame
Baseline to post-treatment (up to 28 weeks)4
Letter Updating
Computerized task assessing working memory updating in youth participants; higher scores indicate better updating abilities.
Time frame
Baseline to post-treatment (up to 28 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida State University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov