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

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ClinicalTrials.gov Identifier: NCT02472860
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Deborah Munroe Noonan Memorial Research Fund
Information provided by (Responsible Party):
Alysa Emily Doyle, PhD, Massachusetts General Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: 6 weeks ]
    Computerized test



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Current ASD symptomatology at time of enrollment
  3. Evidence of decrements in at least one of three target cognitive domains (mental flexibility/abstraction, working memory, or attention).

Exclusion Criteria:

  1. Intellectual Disability
  2. 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).
  3. Nonverbal or minimal verbal ability
  4. No computer/internet connection at home
  5. No family member with e-mail
  6. Patients likely to have a change in therapeutic treatments within the next 6 weeks

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): NCT02472860


Sponsors and Collaborators
Massachusetts General Hospital
Deborah Munroe Noonan Memorial Research Fund
Investigators
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Principal Investigator: Alysa E Doyle, PhD Massachusetts General Hospital

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Responsible Party: Alysa Emily Doyle, PhD, Assistant Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02472860    
Other Study ID Numbers: 2015P000610
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Keywords provided by Alysa Emily Doyle, PhD, Massachusetts General Hospital:
Autism Spectrum Disorder
Neuroplasticity-based Cognitive Training
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders