NCT02472860

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

June 8, 2015

Last Update Submit

March 26, 2018

Conditions

Keywords

Autism Spectrum DisorderNeuroplasticity-based Cognitive Training

Outcome Measures

Primary Outcomes (1)

  • Cambridge Neuropsychological Test Automated Battery (CANTAB)

    Computerized test

    6 weeks

Study Arms (2)

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

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.

Cognitive Training

Engaging games not designed to improve cognition

Control Condition

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alysa E Doyle, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 16, 2015

Study Start

June 1, 2015

Primary Completion

August 2, 2017

Study Completion

August 2, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03