MGHTCT: Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02472860

Collaborator

Deborah Munroe Noonan Memorial Research Fund (Other)

Enrollment

Arms

26.1

Duration (Months)

Study Details

Study Description

Brief Summary

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting cognition in 30 teens with autism spectrum disorder.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Behavioral: Targeted Cognitive Training (TCT) Other: Youth Appropriate Online Games	N/A

Detailed Description

Given the limited options for treatments to improve the core symptoms of autism spectrum disorder (ASD), strategies that could target secondary features of the condition and improve quality of life for affected individuals are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with attention deficit hyperactivity disorder (ADHD) and in adults with schizophrenia. In this trial, the investigators are seeking to extend the relevance of computerized cognitive training to youth with ASD. Given the literature, the investigators hypothesize that computerized cognitive training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ASD. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity based cognitive tests or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 15 hours of training over 6 weeks and then again at a three month follow up.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 2, 2017

Actual Study Completion Date :

Aug 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Training Targeted Cognitive Training (TCT)	Behavioral: Targeted Cognitive Training (TCT) The investigators have selected a set of computer exercises designed to specifically target aspects of cognition relevant to autism spectrum disorder (including attention and executive functions). The tasks were designed to benefit subjects through principles of learning dependent plasticity.
Placebo Comparator: Control Condition Youth appropriate online games	Other: Youth Appropriate Online Games Engaging games not designed to improve cognition

Arm

Intervention/Treatment

Experimental: Cognitive Training

Targeted Cognitive Training (TCT)

Behavioral: Targeted Cognitive Training (TCT)

The investigators have selected a set of computer exercises designed to specifically target aspects of cognition relevant to autism spectrum disorder (including attention and executive functions). The tasks were designed to benefit subjects through principles of learning dependent plasticity.

Placebo Comparator: Control Condition

Youth appropriate online games

Other: Youth Appropriate Online Games

Engaging games not designed to improve cognition

Outcome Measures

Primary Outcome Measures

Cambridge Neuropsychological Test Automated Battery (CANTAB) [6 weeks]
Computerized test

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 ASD or previously diagnosed DSM-IV autistic disorder, Asperger's disorder or pervasive developmental disorder not otherwise specified (NOS) and who continue to manifest symptoms in core domains
Current ASD symptomatology at time of enrollment
Evidence of decrements in at least one of three target cognitive domains (mental flexibility/abstraction, working memory, or attention).

Exclusion Criteria:

Intellectual Disability
A known comorbid neurodevelopmental disorder with possible association with autism (i.e., fragile X syndrome, tuberous sclerosis, Angelman syndrome, Prader-Willi syndrome, Williams syndrome, neurofibromatosis, mitochondrial disorder).
Nonverbal or minimal verbal ability
No computer/internet connection at home
No family member with e-mail
Patients likely to have a change in therapeutic treatments within the next 6 weeks