Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Training in Children With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02813564
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
McMaster University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Cognitive Assessment & Video-game INtervention Solutions (CAVINS) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Targeted Cognitive Training: Assessment and Plasticity in Autism Spectrum Disorder (ASD)
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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).


Secondary Outcome Measures :
  1. Tower of Hanoi: Measuring change in planning ability [ Time Frame: Through study completion, an average of 1 year ]
    measures planning and organizational abilities

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813564


Contacts
Layout table for location contacts
Contact: Diana Parvinchi, PhD 905-525-9140 ext 24784 dparvinchi@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Diana Tajik-Parvinchi, PhD    9056171631    dparvinchi@mcmaster.ca   
Contact: Geoffrey Hall, PhD    9055259140 ext 23033    hallg@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Investigators
Layout table for investigator information
Principal Investigator: Geoffrey Hall, PhD McMaster University
Principal Investigator: Terry Bennett, MD McMaster University
Principal Investigator: Stelios Georgiades, PhD McMaster University

Publications:
MEZZACAPPA, E. & BUCKNER, J. C. 2010. Working memory training for children with attention problems or hyperactivity: A school-based pilot study. School Mental Health, 2, 202-208.

Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02813564     History of Changes
Other Study ID Numbers: 0323
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
Autism
Cognitive Training
Brain
fMRI

Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders