Cognitive Training in Children With ASD

NCT02813564 | Unknown

• 1 other identifier: 0323
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Autism; Cognitive Training; Brain; fMRI

Outcome Measures

Primary Outcomes (5)

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

  This is a set-shifting task

  Through study completion, an average of 1 year

• The Go/NoGo task: Measuring change in inhibitory control

  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

  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

  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

  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 Outcomes (4)

• Tower of Hanoi: Measuring change in planning ability

  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

• Sequential Order (SO): Measuring change in reasoning ability

  Through study completion, an average of 1 year

• The Peabody Picture Vocabulary Test (PPVT): Measuring change in communication abilities

  Through study completion, an average of 1 year

Study Arms (4)

Training group

EXPERIMENTAL

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)

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.

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

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).

Interventions

Cognitive Assessment & Video-game INtervention Solutions (CAVINS) BEHAVIORAL

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.

Training group; fMRI-training group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Geoffrey Hall, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Terry Bennett, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Stelios Georgiades, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Parvinchi, PhD

CONTACT

905-525-9140; dparvinchi@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: June 27, 2016
• Study Start: March 2, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

CA (1)