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临床试验/NCT05384717
NCT05384717已完成不适用

Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022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
21
试验地点
2
主要终点
N-back Visual correct ratio

研究概览

简要总结

Purpose: The purpose of this study is to investigate the usage of fidget technology and its effects on attention, working memory, and comprehension in children ages 6-13 with Attention Deficit Hyperactivity Disorder (ADHD). This study aims to examine the implications of fidget usage 2 different measures of attention; attentional control (working memory domain) and comprehension (recall, encoding, and recognition).

Participants: 6-13 year-old clients at 3-C Family Services, a private mental health clinic in Cary, NC, with a diagnosis of ADHD (Inattentive, Hyperactive, or combined types). Exclusion criteria: participants with an Intelligence Quotient (IQ) below 70 as estimated by referring 3-C clinical staff, or any history of psychosis.

Procedures (methods): This research will use a demographic and background collecting survey to gather relevant data about each participant. Parents will be asked to fill out a baseline ADHD Rating Scale-IV: Home Version (ADHD-RS), to account for their child's symptoms of ADHD over the past 6 months. Participants will be randomly assigned to one of 2 conditions, an experimental group where participants select a fidget, and a control group where participants are not provided a fidget. Fidget options will include a fidget spinner, pop-it, stress ball, and fidget cube as not all children would benefit from the same type of fidget equally. Participants in the experimental group will then be allowed to practice with and familiarize themselves with the fidget for 1 minute to decrease the attentional drain that the fidget may pose in its initial state.

After random assignment to either control or experimental group, participants in each group will then complete the same 2-back version of the N-back Attention Control Task (cognitivefun.net), and a video comprehension multiple choice test. After 3 minutes N-back scores will be recorded including visual correct ratio and visual response time scores. The video comprehension item is adapted from Lee and List, 2019. The video is a Ted Talk titled "The Survival of the Sea Turtle" ( https://www.youtube.com/watch?v=t-KmQ6pGxg4). Items in the multiple choice test will be aggregated to a score of percent correctness for each participant. Participants may request to have questions read to them by the research assistant present.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ADHD

排除标准

  • Psychosis
  • IQ under 70

结局指标

主要结局

N-back Visual correct ratio

时间窗: Day 1 (Up to 30 minutes)

The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. Max value= 1, min value =0, higher scores are closer to 1

N-back visual response time

时间窗: Day 1 (Up to 30 minutes)

The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. The lower the score the better (indicates less time to decide on n-back). For response time measure there is no minimum or maximum.

Number of correct multiple choice responses out of 10

时间窗: Day 1 (Up to 30 minutes)

Participants answer 10 multiple choice questions to assess comprehension of Ted Talk video. Multiple choice questions adapted from Lee \& List, 2019. Max value= 10, min value = 0. Best possible score = 10, higher scores are better.

次要结局

  • Type of fidget selected(Day 1 (Up to 30 minutes))
  • Parent-reported type of ADHD(Day 1 (Up to 30 minutes))
  • ADHD-RS Home Version Score(Day 1 (Up to 30 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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