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

NCT ID: NCT02472860

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-08-02

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cognitive Training

Targeted Cognitive Training (TCT)

Group Type: EXPERIMENTAL

Targeted Cognitive Training (TCT)

Intervention Type: BEHAVIORAL

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.

Control Condition

Youth appropriate online games

Group Type: PLACEBO_COMPARATOR

Youth Appropriate Online Games

Intervention Type: OTHER

Engaging games not designed to improve cognition

Interventions

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.

Intervention Type: BEHAVIORAL

Youth Appropriate Online Games

Engaging games not designed to improve cognition

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deborah Munroe Noonan Memorial Research Fund

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alysa Emily Doyle, PhD

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alysa E Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2015P000610

Identifier Type: -

Identifier Source: org_study_id