NCT02403817

Brief Summary

Current therapies for autism target social and language behaviors, but due to the high-level nature of these skills any improvement rarely extends beyond the targeted behavior. This project uses new technology to implement a novel concept for behavioral intervention to improve basic attention and eye movement skills in ASD. Because these basic skills form the foundation for good social communication, training these abilities has the potential to improve a broad spectrum of clinical symptoms, and in young children may affect the course of development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

March 23, 2015

Results QC Date

August 8, 2019

Last Update Submit

December 3, 2019

Conditions

Keywords

Video Games

Outcome Measures

Primary Outcomes (4)

  • Spatial Attention Baseline

    This behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations.

    Pre-intervention

  • Saccadic Eye Movements Baseline

    This task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task.

    Pre-intervention

  • Change in Spatial Attention at 8 Weeks

    This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention.

    end of Week 8

  • Change in Saccadic Eye Movements at 8 Weeks

    This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task.

    end of Week 8

Study Arms (2)

Eye Movement Game Control

EXPERIMENTAL

Cognitive Training Eye Motor Training

Behavioral: Cognitive TrainingBehavioral: Eye Motor Training

Hand Movement Game Control

ACTIVE COMPARATOR

Cognitive Training Hand Motor Training

Behavioral: Cognitive TrainingBehavioral: Hand Motor Training

Interventions

A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.

Eye Movement Game ControlHand Movement Game Control

Game play will be controlled by the player's eye movements (via an eye tracking device)

Eye Movement Game Control

Game play will be controlled by the player's hand movements (via a joystick).

Hand Movement Game Control

Eligibility Criteria

Age9 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participant has a diagnosis of Autism Spectrum Disorder (on Diagnostic and Statistical Manual -IV, Autism Diagnostic Observation Schedule, Autism Diagnostic Interview-Revised)
  • Participant has a nonverbal Intelligence Quotient (IQ) of 85 or greater and verbal IQ of 70 or greater
  • Cooperative and able to follow instructions
  • Normal hearing acuity
  • Normal or corrected-to-normal vision

You may not qualify if:

  • Major medical or neurological problems including seizures, diagnosed epileptiform EEG abnormalities, migraine, tuberous sclerosis, fragile X, static encephalopathies resulting from prior Central Nervous System insults, significant premature birth, and history of exposure to teratogens, metabolic abnormalities, and history of head trauma, cerebral palsy, stroke, meningitis, brain tumor or additional psychiatric diagnoses
  • Participants currently participating in vision therapy will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093-0959, United States

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Jeanne Townsend, PhD, Professor of Neurosciences
Organization
University of California, San Diego

Study Officials

  • Jeanne Townsend, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This project develops the intervention and includes a small clinical (behavioral) trial for ASD participants. A small number of ASD participants will be randomly assigned to intervention 'games' played by mouse response--the others to gaze-driven response.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosciences

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

November 1, 2015

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

December 4, 2019

Results First Posted

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

De-identified IPD is being shared through National Institutes of Health (NIH) National Database for Autism Research (NDAR).

Time Frame
Data are available to share now (August 8, 2019) and can remain available indefinitely or as long as the National Database for Autism Research is supported.
Access Criteria
Data are shared through the National Database for Autism Research. Access is by registration and meeting eligibility requirements established by the National Institutes of Health for data sharing.

Locations