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临床试验/NCT03429465
NCT03429465已完成不适用

Training Resiliency in Youth (TRY) Study

University of Washington2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年1月16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
46
试验地点
2
主要终点
Executive Function

研究概览

简要总结

The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress. The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires. Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Currently enrolled in 6th grade during the 2017-2018 school year at Lucille Umbarger Elementary School in the Burlington-Edison School District
  • Physical ability to use a touchscreen iPad
  • Cognitive ability to assent, complete questionnaires, and play EVO game
  • English speaking child, English or Spanish speaking parent
  • Child has legal parent/guardian (i.e., not a ward of the state)

排除标准

  • The child is identified by parent or school as diagnosed with an intellectual disability
  • The child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen iPad and appropriate engagement with EVO
  • The child is identified by parent or school as unlikely to engage for 20 minutes with EVO
  • Child unable to read or understand English
  • Parent unable to read or understand English/Spanish
  • Child is in public (i.e., child welfare) custody

结局指标

主要结局

Executive Function

时间窗: Measured 5 times across 5 months

Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.

Behavioral Problems

时间窗: Measured 5 times across 5 months

Measuring difficulties with attention (i.e., attention deficit/hyperactivity disorder), oppositionality, and conduct at home and school as measured by parent-report on children's behavior.

Depression

时间窗: Measured 5 times across 5 months

depression symptoms measured with self- and parent- report

Anxiety

时间窗: Measured 5 times across 5 months

Measuring self- and parent-reported symptoms of anxiety.

次要结局

  • Emotion Regulation(Measured 5 times across 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pat Arean

Professor, School of Medicine: Psychiatry And Behavioral Sciences

University of Washington

研究点 (2)

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