Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders

• ClinicalTrials.gov Identifier: NCT02139514
• Recruitment Status: Completed
• First Posted: May 15, 2014
• Last Update Posted: October 26, 2016
• Sponsor: Yale University
• Collaborator: University of Texas
• Information provided by (Responsible Party): Yale University

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).

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).

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

University of Texas

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02139514
• Other Study ID Numbers: 1211011083
• First Posted: May 15, 2014
• Last Update Posted: October 26, 2016
• Last Verified: October 2016

Keywords provided by Yale University:

Social Skills; Adults

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders