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临床试验/NCT03238118
NCT03238118已完成不适用

Randomized Clinical Trial Comparing Attention Bias Modification, Attention Control and Psychoeducation for Irritability in Children and Adolescents

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)

研究概览

简要总结

The aim of this project is to evaluate the efficacy of an attention bias modification training if compared to an attention control and psychoeducation to reduce the symptoms of irritability among children with high levels of irritability.

详细描述

Children with high levels of irritability have showed significant bias towards threatening faces. Computerized training programs have showed to be able to successfully modify these biases in children with mood and anxiety disorders. Of particular importance, a study examined the effects of attention training towards positive stimuli on attention biases and anxiety symptoms in pediatric anxiety disorders. In the attention-towards-positive condition, children searched picture arrays for a happy face amongst angry faces. In the attention-training control condition, children searched for a bird amongst flowers. This study showed significantly greater reductions in clinician-rated diagnostic severity and number of diagnoses of anxiety with that training. However, no study has investigated the role of these training in children and adolescents with high levels of irritability The present project, aims to examine the effects of the attention bias modification training and compare to attention-training control condition and psychoeducation in children with high levels of irritability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants and caregivers will be blinded to the intervention and control groups. They will not be blinded to the psychoeducation group.

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 9 to 12 years with symptoms of irritability who scored above the 90% percentile for their existing symptoms on Affective Reactivity Index

排除标准

  • a diagnosis of intellectual disability.

结局指标

主要结局

Mean change from baseline to endpoint in the "Irritability Subscale" of The Multidimensional Assessment of Preschool Disruptive Behavior (mean values)

时间窗: two weeks

The Multidimensional Assessment of Preschool Disruptive Behavior is a developmentally sensitive questionnaire, which is used to assess temper loss in terms of tantrum features and anger regulation. A total of 39 items are rated in terms of frequency over the past month: 0 = Never in the past month; 1 = Rarely (less than weekly); 2 = Some days (1-3 days per week); 3 = Most days (4-6 days); 4 = Daily; and 5 = Multiple times per day.

次要结局

  • Mean change from baseline to endpoint in the Affective Reactivity Index(two weeks)
  • Mean change from baseline to endpoint in The Extended Strengths and Weaknesses Assessment of Normal Behavior(two weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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