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
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
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
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
NCT ID
NCT02472860
First Posted
June 8, 2015
Last Updated
March 26, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Deborah Munroe Noonan Memorial Research Fund
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
Learn more about this trial
Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder
We'll reach out to this number within 24 hrs