Psychological Assessment and Treatment of Youth Emotional and Behavioral Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions - Improvement Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment Group
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Clinical Global Impressions - Improvement Scale
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Sherelle Harmon
Principal Investigator
Florida State University