Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
研究概览
简要总结
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview
排除标准
- •Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation
- •Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood
- •IQ < 70 (Raven)
研究组 & 干预措施
PCI+ABMT(placebo)
干预措施: Attentional Bias Modification Treatment - Placebo (Other)
PCI+ABMT(placebo)
干预措施: Psychoeducational Control Intervention (Behavioral)
CBGT+ABMT(active)
干预措施: Attentional Bias Modification Treatment (ABMT) - Active (Other)
PCI+ABMT(active)
干预措施: Attentional Bias Modification Treatment (ABMT) - Active (Other)
PCI+ABMT(active)
干预措施: Psychoeducational Control Intervention (Behavioral)
CBGT+ABMT(placebo)
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
CBGT+ABMT(active)
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
CBGT+ABMT(placebo)
干预措施: Attentional Bias Modification Treatment - Placebo (Other)
结局指标
主要结局
Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
时间窗: Endpoint (week-10) and 6-month follow-up
Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
Pediatric Anxiety Rating Scale (PARS) / continuous
时间窗: Endpoint (week 10) and 6-month follow-up
Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
次要结局
- Screen for Children and Anxiety Related Emotional Disorders (SCARED)(Endpoint (week-10) and 6-months follow-up)
- Childhood Depression Inventory (CDI)(Endpoint (week-10) and 6-month follow-up)
- Spence Children's Anxiety Scale (SCAS)(Endpoint (week-10) and 6-month follow-up)
- Biological measures(Endpoint (week-10) and 6-month follow-up)
- Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)(Endpoint (week-10) and 6-month follow-up)
- Neuropsychological measures(Endpoint (week-10) and 6-month follow-up)