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临床试验/NCT03213613
NCT03213613已完成不适用

Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月13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
60
试验地点
2
主要终点
Test of Variables of Attention (TOVA), visual form, change from baseline

研究概览

简要总结

This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention training in a healthy adolescent population.

详细描述

Aspects of cognitive control, such as attention and working memory, are critical for successful goal-directed behavior. Importantly, variability in cognitive control abilities can influence real-world functioning, such as scholastic success in children and adolescents. The primary goal of this project is to examine the outcomes of a novel, adaptive attention training that primarily targets aspects of sustained attention and secondarily targets delayed gratification in adolescents. As such, the investigators will validate the feasibility and efficacy of this novel training in a randomized controlled trial (RCT) study. Specifically, healthy adolescents (age 12-16 years old) will be recruited for a longitudinal experiment in which they are randomly assigned to the adaptive attention training group ('Engage') or one of two expectancy-matched control groups. Depending on the assigned group, participants will complete 1 hour (low-dose control group) or 15 hours ('Engage' and active control groups) of training as well as pre-, post- and follow-up assessments of cognitive, neural, and behavioral measures. We hypothesize that completion of 'Engage' training will result in enhancement of fronto-parietal control functions that underlie sustained attention and suppression of ventral-striatal reward impulses, ultimately improving these abilities in a healthy adolescent population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy right-handed children, age 12-16 years old
  • No ADHD status (verified with the Vanderbilt ADHD Parent form)
  • Willing and able to undergo MRI and EEG procedures

排除标准

  • Current psychotropic medications
  • Current diagnosis of any axis I psychiatric disorder
  • History of seizure disorder or seizure episodes over the last 2 years
  • Motor/perceptual handicap that prevents computer use

结局指标

主要结局

Test of Variables of Attention (TOVA), visual form, change from baseline

时间窗: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

次要结局

  • Delay Discounting task, change from baseline(Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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