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CompletedNCT02139514Updated Oct 26, 2016

Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders

An interventional study of Virtual Reality Social Cognition Training in Autism Spectrum Disorders, sponsored by Yale University. Completed at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

The purpose of this study is to predict and explain on the basis of brain function and structure the behavioral and brain effects of an evidence-based intervention for adults with high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012; Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned to receive either (a) two hours per week of intervention services for five weeks, or (b) a treatment as usual control. The intervention will focus on enhancing social skills, social cognition, and social functioning. Outcome measures will evaluate changes in these social skills, cognition, and functioning using standardized assessments. We will perform structural and functional magnetic resonance imaging (MRI) scans at three time points-before, during, and after treatment (i.e., Time Point #1, 2, and 3).

Read the detailed description

The purpose of this study is to predict and explain on the basis of brain function and structure the behavioral and brain effects of an evidence-based intervention for adults with high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012; Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned to receive either (a) two hours per week of intervention services for five weeks, or (b) a treatment as usual control. The intervention will focus on enhancing social skills, social cognition, and social functioning. Outcome measures will evaluate changes in these social skills, cognition, and functioning using standardized assessments. We will perform structural and functional magnetic resonance imaging (MRI) scans at three time points-before the treatment, after the treatment, and a 3-month follow-up (i.e., Time Point #1, 2, and 3).

All the recruitment will be taking place at Yale Child Study Center (YCSC), while the intervention will be delivered online by therapists located at the Center for BrainHealth at the University of Texas at Dallas (UTD). The intervention is called Virtual Reality-Social Cognition Training (VR-SCT) and has been approved by the IRB at UTD (approval number #06-54).

02

Conditions studied

  • Autism Spectrum Disorders

Keywords

  • Social Skills
  • Adults
03

In context

Autism Spectrum Disorder

1,726 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's enrollment of 10 is below the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adults:

    1. Age: 18-40, inclusive
    2. A male or female outpatient

  2. High-functioning (so that the treatment can effectively benefit the subjects):

    1. Full Scale Intelligence Quotient (IQ) of WASI at least 80
    2. Able to give informed consent prior to initiation of any protocol required procedures

  3. Autism Spectrum Disorder:

    1. Having a current primary diagnosis of Autism Spectrum Disorder (including Asperger's Disorder) from a licensed psychologist/psychiatrist or from a school diagnostician, as defined by the DSM-IV criteria.
    2. For this project, diagnosis will not be determined by our assessment. The participants we enroll will already carry a current primary diagnosis of Autism Spectrum Disorder. This verification of their diagnosis may also come from study personnel who have seen and/or treated the patient prior to his or her involvement in the project and can verbally confirm that they carry the proper diagnosis.
  4. Mean Length of Utterance (MLU) must be at least 4-5 words (the intervention method requires this)

Exclusion criteria

Exclusion Criteria:

  1. Speech-language criteria:

    1. Those who are not fluent in written and oral English will not be eligible to participate, as many of the instruments are not validated in other languages.
    2. Significant hearing loss or other severe sensory impairment
    3. Inability to read self-report instruments

  2. Health criteria:

    1. Those whose clinical status (e.g., serious suicidal or homicidal risk) requires inpatient or day hospital treatment
    2. Those with a history of seizures, or current use of anticonvulsants
    3. A fragile health status
    4. A history of significant head trauma or serious brain or psychiatric illness
    5. Having any other current psychiatric condition or complications, such as

    i. Diagnosed with substance dependence within the last three months. ii. Current use of prescription medications that may affect cognitive processes under study.

    iii. Current primary diagnosis of bipolar disorder I or II iv. Axis I psychopathology v. Depression

  3. Any metal or electromagnetic implants, including:

    1. Cardiac pacemaker
    2. Defibrillator
    3. Artificial heart valve
    4. Aneurysm clip
    5. Cochlear implants
    6. Shrapnel
    7. Neurostimulators
    8. History of metal fragments in eyes or skin
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Virtual Reality Social Cognition Training

    Virtual Reality Social Cognition Training

    Behavioral: Virtual Reality Social Cognition Training

  • No intervention
    Control

    Participants in the Control condition will be offered treatment following the Control condition.

Interventions

  • BehavioralVirtual Reality Social Cognition Training

    Social skills training via virtual reality with trained therapist.

06

What researchers measure

Primary outcomes

  1. functional magnetic resonance imaging (MRI)

    Time frame: up to 6 weeks

07

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06520, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02139514
Lead sponsor
Yale University
Collaborators
University of Texas
Responsible party
Sponsor
First posted
May 15, 2014
Start date
Jan 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 26, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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