Cognitive Training in Children With ASD

August 17, 2018 updated by: McMaster University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Although these recent theories of ASD point to deficits of executive functions, this field is currently lacking an evidence-based intervention, which directly tackles deficits of executive functions. The existing interventions for ASD (mainly consisting of behavioural skills development) are complex in administration and require highly trained staff. As a result, these approaches have placed an extremely high demand on clinics and practitioners creating long wait lists. These approaches have poor accessibility for many families and schools. The most striking and consistent limitation of the existing interventions is an apparent lack of transfer of learned skills to other conditions and contexts. Meaning, new learned behaviours are limited to the specific context in which they are trained. Generalization to other tasks and contexts is a distinguishing strength of cognitive training, this approach can be used at home via a personal computer providing more accessibility, and it can be used in conjunction with the behavioral skills development to improve the child's receptiveness to learning. Thus, cognitive training may have the potential to provide promising results in the areas where the existing treatments have shown limitations.

The present project intends to first develop a software based cognitive training program tailored to cognitive needs of children with ASD (Cognitive Assessment and Video-game Intervention Solutions, CAVINS)(phase 1) and then examine the program's efficacy through clinical trials and imaging of the brain (Clinical Trials and Imaging Phases). The imaging component will provide the opportunity to learn about the neural framework of some of the targeted cognitive processes as well as training-induced changes in each process. This intervention will target several functions implicated in ASD such as the ability to shift attention to a different aspect of the task, inhibitory control, working memory, planning, reasoning, selective attention, and face processing. During the imaging phase, as our first step, the investigators will use functional Magnetic Resonance Imaging (fMRI) to identify training-induced changes in the brain associated with set-shifting and response inhibition.

Response inhibition consists of two distinct forms, the restraint of a response and the cancellation of a response. Preventing a response from being initiated characterizes the restraint process whereas termination of a response that is already underway represents the cancellation process. Additionally the ability to monitor, detect and adjust behaviour following an erroneous response represents error processing and is an inherent component of response inhibition. Difficulties of response inhibition have been hypothesized to be responsible for the stereotyped and repetitive behaviour observed in ASD, predictive of "theory of mind" performances in preschoolers, and associated with altered connectivity between the frontal cortex and the striatal and parietal regions as well as volume differences and altered development of the striatum. Similarly, lower accuracy on set-shifting tasks is associated with reduced activation in frontal, striatal, and parietal cortexes and is hypothesized to be responsible for mental inflexibility, restricted and repetitive behaviours observed in ASD.

Several imaging studies have demonstrated modifications in the underlying neural network following completion of cognitive training in healthy adults. However, similar studies in children are very scarce. Currently, there are no studies that have examined training-induced changes within the brain in children with ASD. Findings from the present project will reveal benefits of cognitive training in ASD, generalization and persistence of potential benefits, identify biological changes associated with training, and provide much needed insight into the plasticity of the systems supporting two cognitive functions implicated in ASD.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Recruiting
        • McMaster University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training group
This group of children will receive the software based intervention program (CAVINS) and will train at home during the training phase.
Behavioral: Cognitive Assessment & Video-game INtervention Solutions (CAVINS)
This is a computerized "video-game" like intervention. The participants will exercise/strengthen the cognitive (mental) deficits that may be responsible for symptom profiles such as socialization impairments, academic disabilities, and repetitive behaviour for several weeks. This program will stimulate communication between brain regions that make up an information processing neural network in order to promote proper network development.
No Intervention: Control group
This group of children will play video-games-as-usual and return in about 3 weeks for their next assessment appointment.
Experimental: fMRI-training group
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.
Behavioral: Cognitive Assessment & Video-game INtervention Solutions (CAVINS)
This is a computerized "video-game" like intervention. The participants will exercise/strengthen the cognitive (mental) deficits that may be responsible for symptom profiles such as socialization impairments, academic disabilities, and repetitive behaviour for several weeks. This program will stimulate communication between brain regions that make up an information processing neural network in order to promote proper network development.
No Intervention: fMRI-Control group
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Dimensional Change Card Sorting task (DCCS): Measuring change in mental flexibility
Time Frame: Through study completion, an average of 1 year
This is a set-shifting task
Through study completion, an average of 1 year
The Go/NoGo task: Measuring change in inhibitory control
Time Frame: Through study completion, an average of 1 year
This is a response inhibition task
Through study completion, an average of 1 year
The preschool version of the Behavior Rating Inventory of Executive Function (BRIEF-P): Measuring change in everyday executive functions
Time Frame: Through study completion, an average of 1 year
This questionnaire captures real life executive control abilities of children
Through study completion, an average of 1 year
Flanker Test: Measuring change in selective attention
Time Frame: 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
Through study completion, an average of 1 year
Aberrant Behaviour Checklist (ABC): Measuring change in behaviour
Time Frame: 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).
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tower of Hanoi: Measuring change in planning ability
Time Frame: Through study completion, an average of 1 year
measures planning and organizational abilities
Through study completion, an average of 1 year
The Stroop-like day-night: Measuring change in inhibitory control
Time Frame: Through study completion, an average of 1 year
This task has been used to measure working memory + inhibition
Through study completion, an average of 1 year
Sequential Order (SO): Measuring change in reasoning ability
Time Frame: Through study completion, an average of 1 year
A measure of children's fluid reasoning
Through study completion, an average of 1 year
The Peabody Picture Vocabulary Test (PPVT): Measuring change in communication abilities
Time Frame: Through study completion, an average of 1 year
A language assessment scale
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Geoffrey Hall, PhD, McMaster University
  • Principal Investigator: Terry Bennett, MD, McMaster University
  • Principal Investigator: Stelios Georgiades, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0323

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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