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临床试验/NCT02688959
NCT02688959招募中不适用

A Feasibility/Pilot Trial of a Motor Attention Training Intervention for College Students With ADHD

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2016年2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
招募中
入组人数
145
试验地点
2
主要终点
Change in symptoms of inattention

研究概览

简要总结

The investigators will perform a feasibility/pilot trial of two non-pharmacological interventions for ADHD in college students.

详细描述

College students diagnosed with ADHD will be randomized to three arms of approximately 8 weeks duration: (1) standard care plus a tai chi class, (2) standard care plus an exercise class, and (3) standard care alone. The exercise class will control for the social and motor components of tai chi training. The investigators will determine methodological parameters relevant to a subsequent full scale trial including recruitment and retention rates, acceptance of randomization, adherence to the interventions, and variance in outcome measures. The primary clinical outcome measure of this pilot randomized controlled trial (RCT) will be pre- to post-intervention change in inattention, i.e. the Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L, see Interviews etc. "Converse_S_L"). Secondary measures to be explored will include self- and informant-report, neurocognitive measures, psychophysiological measures, and academic performance. Practice time will be assessed daily and follow-up self-report of ADHD symptoms will be gathered monthly for 3 months beyond the end of the intervention.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 23 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • University of Wisconsin-Madison enrolled undergraduate
  • Documented ADHD diagnosis

排除标准

  • Unable or unwilling to participate in the interventions

研究组 & 干预措施

Control

No Intervention

Participants in the control arm will not attend a class and not be given a video.

Tai Chi

Experimental

Participants in this arm will attend 50-minute classes 2 times per week for 8 weeks. The course will emphasize experiential learning with 2 weeks of introductory sessions on gait, posture, and tai chi principles followed by instruction in the 24-form Yang style sequence. Students will be given a video to aid learning outside of class, and maintenance of practice post-intervention.

干预措施: Tai Chi (Behavioral)

Exercise

Active Comparator

Participants in the exercise arm will attend 50-minute classes 2 times per week for 8 weeks. The course will emphasize cardio-aerobic fitness training. Students will be given a video to aid practice outside of class, and maintenance of practice post-intervention.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Change in symptoms of inattention

时间窗: 8 weeks

Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L). The total range of scores is 0-27 with higher scores indicating more severe symptom levels.

次要结局

  • Feasibility of implementing wireless Electroencephalogram(EEG) to measure the theta beta ratio during performance of tai chi.(up to 90 minute)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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