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临床试验/NCT02813564
NCT02813564Unknown不适用

Targeted Cognitive Training: Assessment and Plasticity in Autism Spectrum Disorder (ASD)

McMaster University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
The Go/NoGo task: Measuring change in inhibitory control

研究概览

简要总结

Plasticity refers to susceptibility of an organism to change. Cognitive training is an intervention approach based on the notion of plasticity. It entails the repeated exercise of a set of higher-order cognitive abilities over several weeks after which performance gains are expected on the trained as well as untrained tasks. Cognitive training has produced successful results in various clinical groups, but its benefits have not been explored in Autism Spectrum Disorder (ASD). The present study will develop a software-based training program tailored to the cognitive deficits in ASD. The investigators will also examine possible training-induced functional changes within the brain using functional Magnetic Resonance Imaging (fMRI). Fifty children with ASD 3-7 years will be recruited and randomly assigned to the control (n=25) or the training group (n=25). A subgroup of these samples will carry out the response inhibition and set-shifting tasks in the fMRI scanner. The study will consist of a pre-post design and a four-month follow up. Repeated measures Analysis of Variance (ANOVA) will be carried out with group (training, control) as the between subjects factor and Time (pre- post-training, follow-up) as the within subjects factor to identify training induced cognitive improvements. To determine training-induced biological changes within the brain, activity maps associated with response inhibition and set-shifting at pre-training and post-training sessions will be entered into a group ANOVA and contrasted for differences within- and between groups.

详细描述

  1. INTRODUCTION Autism Spectrum Disorder (ASD) is a severe neurodevelopmental disorder characterized by deficits of social and communicative skills, restricted set of interests, activities and/or repetitive behaviours that are typically observed in early childhood. The prevalence of ASD is about 1 in 68 children and it is the fastest growing developmental disability. The cost of diagnosing and treating ASD is estimated to be around $236-262 billion annually.

Plasticity broadly refers to the susceptibility of an organism to change. The human brain shows incredible plastic capacity. Multiple neuronal networks can sustain the same cognitive function (a mental ability) with different systems supporting the same function in different individuals. This "many-to-one" structure-function relationship is one form of plasticity. Examining neural networks responsible for a cognitive process in different individuals can provide insight into the plastic capacity of that process.

Cognitive training is centered on the notion of plasticity. It entails the repeated exercise of a specific cognitive process (or multiple processes) over several weeks, after which performance gains are expected on the trained task as well as various untrained tasks that directly or indirectly involve the targeted cognitive process(s). The generalization of performance gains to untrained tasks is termed "transfer" and is essential to the efficacy of the training. Cognitive training has been used to remediate deficits in adults with strokes, multiple sclerosis, Schizophrenia, children with working memory deficits , children with attention deficit hyperactivity disorder (ADHD), healthy pre-kindergarten children, as well as to enhance cognitive performance in healthy young adults, and healthy older adults. Yet, the benefits of this intervention for children with ASD have received relatively little attention.

Recent research indicates that disrupted patterns of cortical development in ASD may lead to its clinical manifestation. More specifically earlier reports have shown a pattern of reduced long-range cortical connectivity and increased localized functional connectivity in ASD. This pattern has been recently verified using highly stringent imaging analysis methods. This altered functional connectivity may be especially disruptive to cognitive functions that demand integrative information processing such as executive functioning (higher order cognitive functions that control other cognitive processes eg. Conscious control of thought and action), theory of mind, face processing, language and communication, all of which have been previously established as impaired processes in ASD.

Moreover, approximately 50-70% of children with ASD are diagnosed with intellectual disability, which manifests as cognitive impairments. Intellectual disability has been shown to place children with ASD at risk for a "low functioning" trajectory throughout life and at risk for having more severe symptoms. Cognitive training has been shown to enhance executive functions underlying intellectual capacity such as working memory, fluid intelligence, executive attention as well as academic achievement . Cognitive training delivered at an early age may strengthen the processes that are important for intellectual capacity and therefore improve the clinical trajectory of ASD.

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 (Participant)

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of ASD
  • Age between 3-7 years

排除标准

  • History of head injury
  • Current medical problems that would preclude their participation in the study

研究组 & 干预措施

Training group

Experimental

This group of children will receive the software based intervention program (CAVINS) and will train at home during the training phase.

干预措施: Cognitive Assessment & Video-game INtervention Solutions (CAVINS) (Behavioral)

Control group

No Intervention

This group of children will play video-games-as-usual and return in about 3 weeks for their next assessment appointment.

fMRI-training group

Experimental

This sub-group of children from the "Training group" will carry out two of the tasks in the fMRI scanner during the baseline appointment. They will then go home and train on CAVINS (the intervention) during the training phase.

干预措施: Cognitive Assessment & Video-game INtervention Solutions (CAVINS) (Behavioral)

fMRI-Control group

No Intervention

This sub-group of children from the "Control group" will carry out two of the tasks in the fMRI scanner during the baseline appointment. They will then go home and play video-games-as-usual until their next assessment appointment (after about 3 weeks).

结局指标

主要结局

The Go/NoGo task: Measuring change in inhibitory control

时间窗: Through study completion, an average of 1 year

This is a response inhibition task

The Dimensional Change Card Sorting task (DCCS): Measuring change in mental flexibility

时间窗: Through study completion, an average of 1 year

This is a set-shifting task

Flanker Test: Measuring change in selective attention

时间窗: Through study completion, an average of 1 year

This task measures the ability to pay attention to a given aspect of a task and ignore distractors

The preschool version of the Behavior Rating Inventory of Executive Function (BRIEF-P): Measuring change in everyday executive functions

时间窗: Through study completion, an average of 1 year

This questionnaire captures real life executive control abilities of children

Aberrant Behaviour Checklist (ABC): Measuring change in behaviour

时间窗: Through study completion, an average of 1 year

This is a rating scale. A person who knows the participant well completes it. This scale will captures behavioural symptom areas. The informant rates the participant on a scale from 0 (not at all a problem) to 3 (the problem is severe in degree).

次要结局

  • The Peabody Picture Vocabulary Test (PPVT): Measuring change in communication abilities(Through study completion, an average of 1 year)
  • The Stroop-like day-night: Measuring change in inhibitory control(Through study completion, an average of 1 year)
  • Tower of Hanoi: Measuring change in planning ability(Through study completion, an average of 1 year)
  • Sequential Order (SO): Measuring change in reasoning ability(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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