Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders

NCT02139514 | Completed

• 1 other identifier: 1211011083
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorders

Keywords

Social Skills; Adults

Outcome Measures

Primary Outcomes (1)

• functional magnetic resonance imaging (MRI)

  up to 6 weeks

Study Arms (2)

Virtual Reality Social Cognition Training

ACTIVE COMPARATOR

Virtual Reality Social Cognition Training

Behavioral: Virtual Reality Social Cognition Training

Control

NO INTERVENTION

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

Interventions

Virtual Reality Social Cognition Training BEHAVIORAL

Social skills training via virtual reality with trained therapist.

Virtual Reality Social Cognition Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• University of Texas: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)