Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139514
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Yale University

Brief 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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: Virtual Reality Social Cognition Training Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Virtual Reality Social Cognition Training
Virtual Reality Social Cognition Training
Behavioral: Virtual Reality Social Cognition Training
Social skills training via virtual reality with trained therapist.

No Intervention: Control
Participants in the Control condition will be offered treatment following the Control condition.



Primary Outcome Measures :
  1. functional magnetic resonance imaging (MRI) [ Time Frame: up to 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139514


Locations
Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
University of Texas
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02139514    
Other Study ID Numbers: 1211011083
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Yale University:
Social Skills
Adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders