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临床试验/NCT03932032
NCT03932032已完成不适用

Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth

Florida International University4 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
4
主要终点
P1 amplitude elicited in the dot-probe task

研究概览

简要总结

This two-site study is a test of Attention Bias Modification Treatment (ABMT) among 260 youths ages 10 to 14 years with social anxiety disorder. One-half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive 8 sessions of computer administered Neutral Control Task (NCT). The investigators hypothesize that a biomarker of attention to social threat measured using electroencephalography (EEG) and ratings of social anxiety severity will be lower in participants who receive ABMT compared to participants who receive NCT.

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)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Be between ages 10 and 14 years
  • meet DSM5 criteria for a diagnosis of Social Anxiety Disorder
  • presence of any coexisting psychiatric diagnoses must be of lesser severity than Social Anxiety Disorder
  • have no current psychotropic medication other than a stable dose of stimulant or non-stimulant medication for coexisting ADHD

排除标准

  • meet DSM5 criteria for Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
  • show high likelihood of hurting self or others
  • be a victim of undisclosed abuse requiring investigation/ supervision by the Department of Social Services
  • have an uncorrected vision or physical disability that interferes with the ability to click a mouse button rapidly and repeatedly
  • have a history of neurological illness, including seizures/epilepsy, or head injury with loss of consciousness > 5 minutes

研究组 & 干预措施

Attention Bias Modification Treatment

Experimental

Attention Bias Modification Treatment is a computer-based attention training program.

干预措施: Attention Bias Modification Treatment (Behavioral)

Neutral Control Task

Sham Comparator

Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.

干预措施: Neutral Control Task (Behavioral)

结局指标

主要结局

P1 amplitude elicited in the dot-probe task

时间窗: Follow-up (six months after completing the final treatment session)

Follow-up P1 event related potential amplitude elicited during the emotional faces dot probe task. The investigators will focus specifically on the P1 amplitude time-locked to the onset of facial stimuli in the dot probe task. P1 amplitude will be measured using EEG methodology.

P1 Amplitude Elicited in the Dot-probe Task

时间窗: post-intervention (within one week of completing the final treatment session)

Posttreatment event related potential amplitude elicited during the emotional faces dot probe task. The investigators focused specifically on the P1 amplitude time-locked to the onset of emotional facial stimuli in the dot probe task. P1 amplitude was measured using EEG methodology. Higher scores indicate greater allocation of neural resources when viewing stimuli in the dot probe task, which can be interpreted as an indicator of greater attention orientation to emotional facial stimuli.

P1 Amplitude Elicited in the Dot-probe Task

时间窗: Follow-up (six months after completing the final treatment session)

Follow-up P1 event related potential amplitude elicited during the emotional faces dot probe task. The investigators focused specifically on the P1 amplitude time-locked to the onset of emotional facial stimuli in the dot probe task. P1 amplitude was measured using EEG methodology. Higher scores indicate greater allocation of neural resources when viewing stimuli in the dot probe task, which can be interpreted as an indicator of greater attention orientation to emotional facial stimuli.

次要结局

  • Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at posttreatment(7 days)
  • Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up(7 days)
  • Liebowitz Social Anxiety Scale for Children and Adolescents(Follow-up (six months after completing the final treatment session))
  • Liebowitz Social Anxiety Scale for Children and Adolescents(post-intervention (within one week of completing the final treatment session))
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment(post-intervention (within one week of completing the final treatment session))
  • Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up(Follow-up (six months after completing the final treatment session))
  • Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment(post-intervention (within one week of completing the final treatment session))
  • Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up(Follow-up (six months after completing the final treatment session))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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