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临床试验/NCT02560454
NCT02560454已完成不适用

Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年1月最近更新:
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
83
试验地点
2
主要终点
The ADHD Rating Scale IV (ADHD RS)

研究概览

简要总结

ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.

Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.

In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.

To address these challenges, this study will follow a randomized and controlled design.

The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:

  1. ADHD symptoms,
  2. cognitive functioning,
  3. attentional capacities
  4. academic achievement.

The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.

Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.

详细描述

Attention-Deficit Hyperactivity Disorder (ADHD) is a chronic developmental disorder characterized by symptoms of inattention, impulsivity and hyperactivity that do not correspond to the child's developmental level (American Psychiatric Association, 2013). For a diagnosis to be confirmed, symptoms must be present before age 12 and must be observed in at least to two domains of functioning, such as school, work, social interactions and family life (American Psychiatric Association, 2013).

ADHD is one of the most common neurobehavioral disorder with a prevalence estimated at about 5-7% for school-age children (Psychiatric Association, 2013).

ADHD alters family, social and academic functioning as well as one's professional life.

Results from studies indicated that working memory and inhibition are often altered in ADHD in childhood and persist into adulthood.

Pharmacological treatments of ADHD mostly include psychostimulants (Amphetamine and Methylphenidate) and non-stimulants (Atomoxetine, Clonidine, Guanfacine). Stimulants and no-stimulants are effective in managing ADHD symptoms.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age ≥ 8 et ≤ 12, (2)
  • ADHD diagnostic according to DSM IV or V criteria,
  • score between 28 to 40 for The ADHD-RS,
  • IQ-score, non-verbal reasoning (WISC-III or IV) ≥80, verbal reasoning (WISC-III or IV) ≥80,
  • have internet and a computer at home,
  • if methylphenidate treatments must not be changed for six months, (7) written consent by legal guardian.

排除标准

  • Participant taking other medication than methylphenidate won't be included.
  • Participant suffering from another neurological disorder than ADHD won't be included

研究组 & 干预措施

Cogmed®

Experimental

Cogmed® : working memory training (unifactorial) Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

干预措施: Cogmed (Behavioral)

Presco®

Experimental

Presco® : different cognitive function are trained (multifactorial) Before beginning the program an appointment of one hour will be organized to present the program.

Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.

A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.

干预措施: Presco (Behavioral)

Control

No Intervention

Control ( waiting list)

结局指标

主要结局

The ADHD Rating Scale IV (ADHD RS)

时间窗: 6 weeks

次要结局

  • ADHD Scale(6 weeks and 6 months)
  • TEA-Ch and Continuous Performance Test(6 weeks and 6 months)
  • Wechsler Test (WIAT-II CDN-F)(6 weeks and 6 months)
  • Behavior Rating Inventory of Executive Function (BRIEF)(6 weeks and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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