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

Autism Spectrum Disorder Clinical Trial

— MGHTCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472860
• Other study ID #: 2015P000610
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: March 26, 2018
• Start date: June 2015
• Est. completion date: August 2, 2017

Study information

• Verified date: March 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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.

Other:
• Youth Appropriate Online Games
Engaging games not designed to improve cognition

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Deborah Munroe Noonan Memorial Research Fund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cambridge Neuropsychological Test Automated Battery (CANTAB)	Computerized test	6 weeks