Feasibility and Effectiveness of Computerized Cognitive T... | NCT02472860

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

NCT02472860

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 27, 2018Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Autism Spectrum Disorder

Interventions

Targeted Cognitive Training (TCT)
Youth Appropriate Online Games

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Aug 2, 2017Actual

Completion Date

Aug 2, 2017Actual

First Submitted Date

Jun 8, 2015

First Submission Date that Met QC Criteria

Jun 11, 2015

First Posted Date

Jun 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alysa Emily Doyle, PhD, Assistant Professor of Psychiatry, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Deborah Munroe Noonan Memorial Research Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Training	Experimental	Targeted Cognitive Training (TCT)	Behavioral: Targeted Cognitive Training (TCT)
Control Condition	Placebo Comparator	Youth appropriate online games	Other: Youth Appropriate Online Games

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Targeted Cognitive Training (TCT)	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cambridge Neuropsychological Test Automated Battery (CANTAB)	Computerized test	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alysa E Doyle, PhD	Massachusetts General Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

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Browse Branches

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