- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472860
Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder (MGHTCT)
March 26, 2018 updated by: Alysa Emily Doyle, PhD, Massachusetts General Hospital
The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting cognition in 30 teens with autism spectrum disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Training
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
|
Engaging games not designed to improve cognition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame: 6 weeks
|
Computerized test
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alysa E Doyle, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
August 2, 2017
Study Completion (Actual)
August 2, 2017
Study Registration Dates
First Submitted
June 8, 2015
First Submitted That Met QC Criteria
June 11, 2015
First Posted (Estimate)
June 16, 2015
Study Record Updates
Last Update Posted (Actual)
March 27, 2018
Last Update Submitted That Met QC Criteria
March 26, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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