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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Youth Appropriate Online Games; Behavioral: Targeted Cognitive Training (TCT)

• Registration Number: NCT02472860
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Primary Completion: 2017-08-02
• Study Completion: 2017-08-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Condition	Youth Appropriate Online Games	Youth appropriate online games
Cognitive Training	Targeted Cognitive Training (TCT)	Targeted Cognitive Training (TCT)

Primary Outcome Measures

Name	Time	Method
Cambridge Neuropsychological Test Automated Battery (CANTAB)	6 weeks	Computerized test