Back to resultsVirtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Social Cognition Training
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Social Skills, Adults
Eligibility Criteria
Inclusion Criteria:
Adults:
- Age: 18-40, inclusive
- A male or female outpatient
High-functioning (so that the treatment can effectively benefit the subjects):
- Full Scale Intelligence Quotient (IQ) of WASI at least 80
- Able to give informed consent prior to initiation of any protocol required procedures
Autism Spectrum Disorder:
- 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.
- 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.
- Mean Length of Utterance (MLU) must be at least 4-5 words (the intervention method requires this)
Exclusion Criteria:
Speech-language criteria:
- 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.
- Significant hearing loss or other severe sensory impairment
- Inability to read self-report instruments
Health criteria:
- Those whose clinical status (e.g., serious suicidal or homicidal risk) requires inpatient or day hospital treatment
- Those with a history of seizures, or current use of anticonvulsants
- A fragile health status
- A history of significant head trauma or serious brain or psychiatric illness
- 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
Any metal or electromagnetic implants, including:
- Cardiac pacemaker
- Defibrillator
- Artificial heart valve
- Aneurysm clip
- Cochlear implants
- Shrapnel
- Neurostimulators
- History of metal fragments in eyes or skin
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Virtual Reality Social Cognition Training
Control
Arm Description
Virtual Reality Social Cognition Training
Participants in the Control condition will be offered treatment following the Control condition.
Outcomes
Primary Outcome Measures
functional magnetic resonance imaging (MRI)
Secondary Outcome Measures
Full Information
NCT ID
NCT02139514
First Posted
May 13, 2014
Last Updated
October 24, 2016
Sponsor
Yale University
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT02139514
Brief Title
Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of Texas
4. Oversight
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
Social Skills, Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Social Cognition Training
Arm Type
Active Comparator
Arm Description
Virtual Reality Social Cognition Training
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the Control condition will be offered treatment following the Control condition.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Social Cognition Training
Intervention Description
Social skills training via virtual reality with trained therapist.
Primary Outcome Measure Information:
Title
functional magnetic resonance imaging (MRI)
Time Frame
up to 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults:
Age: 18-40, inclusive
A male or female outpatient
High-functioning (so that the treatment can effectively benefit the subjects):
Full Scale Intelligence Quotient (IQ) of WASI at least 80
Able to give informed consent prior to initiation of any protocol required procedures
Autism Spectrum Disorder:
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.
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.
Mean Length of Utterance (MLU) must be at least 4-5 words (the intervention method requires this)
Exclusion Criteria:
Speech-language criteria:
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.
Significant hearing loss or other severe sensory impairment
Inability to read self-report instruments
Health criteria:
Those whose clinical status (e.g., serious suicidal or homicidal risk) requires inpatient or day hospital treatment
Those with a history of seizures, or current use of anticonvulsants
A fragile health status
A history of significant head trauma or serious brain or psychiatric illness
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
Any metal or electromagnetic implants, including:
Cardiac pacemaker
Defibrillator
Artificial heart valve
Aneurysm clip
Cochlear implants
Shrapnel
Neurostimulators
History of metal fragments in eyes or skin
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
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Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders
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