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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Targeted Cognitive Training (TCT)
Youth Appropriate Online Games
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Neuroplasticity-based Cognitive Training

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Cognitive Training

    Control Condition

    Arm Description

    Targeted Cognitive Training (TCT)

    Youth appropriate online games

    Outcomes

    Primary Outcome Measures

    Cambridge Neuropsychological Test Automated Battery (CANTAB)
    Computerized test

    Secondary Outcome Measures

    Full Information

    First Posted
    June 8, 2015
    Last Updated
    March 26, 2018
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Deborah Munroe Noonan Memorial Research Fund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02472860
    Brief Title
    Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder
    Acronym
    MGHTCT
    Official Title
    Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    August 2, 2017 (Actual)
    Study Completion Date
    August 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Deborah Munroe Noonan Memorial Research Fund

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Autism Spectrum Disorder, Neuroplasticity-based Cognitive Training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Training
    Arm Type
    Experimental
    Arm Description
    Targeted Cognitive Training (TCT)
    Arm Title
    Control Condition
    Arm Type
    Placebo Comparator
    Arm Description
    Youth appropriate online games
    Intervention Type
    Behavioral
    Intervention Name(s)
    Targeted Cognitive Training (TCT)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Youth Appropriate Online Games
    Intervention Description
    Engaging games not designed to improve cognition
    Primary Outcome Measure Information:
    Title
    Cambridge Neuropsychological Test Automated Battery (CANTAB)
    Description
    Computerized test
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alysa E Doyle, PhD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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