Recruiting

Cognitive Training

Sponsor:

McMaster University

Code:

NCT02813564

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Interventions

Cognitive Assessment & Video-game INtervention Solutions (CAVINS)

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT02813564

Start date

Mar 2, 2018

Status verified date

Aug, 2018

Completion date

Mar 1, 2020

Anticipated

Primary completion date

Mar 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Training group

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

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.

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).

Interventions

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.

Primary outcome measure

  • The Dimensional Change Card Sorting task (DCCS): Measuring change in mental flexibility [ Time Frame: 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 ]
  • 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 ]
  • Flanker Test: Measuring change in selective attention [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Diana Tajik-Parvinchi, PhD

9056171631dparvinchi@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Aug 21, 2018

Last verified

Aug, 2018

Keywords

  • Autism
  • Cognitive Training
  • Brain
  • fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by McMaster University on 2018-08-21.