Social Cognition Assessment in Young Adults

May 2, 2018 updated by: The University of Texas at Dallas
The primary objective of this study is to determine the efficacy and feasibility of a battery of neuropsychological measures evaluating social cognition and behavior in young adults diagnosed with schizophrenia, autism spectrum disorders, or traumatic brain injury (TBI). It also investigates functional differences in regions of the brain associated with social cognition and differences in cognitive processing. Additionally, this study implements a virtual reality intervention to strengthen social cognition skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This purpose of the study is to create a comprehensive social cognitive battery and virtual reality therapy that will be useful in determining and treating social deficits in young adults. With such developments, young adults with social cognition impairment may be provided a way to thoroughly evaluate and treat their deficits.

Participants will be screened for eligibility by research staff. Individuals that have met all enrollment criteria and have provided written consent will be entered into the study. Once written consent has been obtained, participants will enter into the assessment phase of the study, followed by the treatment phase. Both neuropsychological social-cognitive testing and functional magnetic resonance imaging (fMRI) measures will be administered prior and following the treatment phase of the study. The treatment phase will entail use of a virtual-reality platform in which to train and practice social interaction skills. Participants will be reimbursed for the pre- and post- assessment portions only. No compensation will be provided for completing the training.

The first scheduled assessment visits will assess the efficacy and feasibility of a battery of standardized measures as well as measures that are being developed specifically for use with this population, assessing mainly social skills and face processing. The pre-training neuropsychological assessment visit is estimated to take up to 4 hours to complete, however can take longer due to each individual's processing style and social-cognitive abilities. Participants will be scheduled for appointments to conduct both the neuropsychological testing and be given the option to complete an fMRI assessment. The pre-training fMRI assessment visit is estimated to take 1 to 1.5 hours to complete.

Once participants have completed the pre-training assessment, they will enter into the treatment phase of the study and participate in the Virtual Reality Social Cognition Training. Participants will be seen 1-2 times a week for up to six weeks. Session length may range in time from 1 hour to 2 hours each week. Each visit will consist of the participant and clinician engaging in a semi-structured live conversation over a virtual-reality platform. Both the participant and the clinician will talk and interact within the virtual environment through a digital character, an avatar. Each conversation will be set-up, initiated, and conducted by coach and/or confederate clinicians that have been trained to administer the treatment. The confederate clinician will be able to change his/her likeness and voice (through voice modulation software) so as to play the role of the conversation partner with the participant. Live feedback and coaching will be provided by the coach clinician to build social reasoning and thinking skills. Each session will center around a specific social objective (e.g., initiating conversation, conducting a job interview, confronting a friend, going on a blind date) while allowing practicing of specific social strategies. Social strategies will be presented in a hierarchical manner, increasing in complexity throughout the training, to strengthen awareness of and application of social reasoning and thinking skills. Strategies practiced include: 1)recognizing other's social intentions, 2)social response, and 3)self-assertion and social problem solving.

Following completion of the treatment phase, participants will complete post-assessment measures that include neuropsychological social cognitive assessments and an fMRI imaging assessment. The post-neuropsychological assessment visit is estimated to take up to 3 hours to complete where as the post- fMRI visit is estimated to take 1 to 1.5 hours to complete.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Center for BrainHealth University of Texas at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current primary diagnosis of schizophrenia, schizoaffective disorder, or autism spectrum disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Traumatic Brain Injury (TBI), or healthy control.
  • Between the ages of 17 and 40
  • TBI must be a close-head injury, at least one year post-injury
  • Intelligence Quotient (IQ) at least 80 or above
  • Mean Length of Utterance (MLU) must be 4-5 words.

Exclusion Criteria:

  • Not fluent in written and oral English
  • Clinical status that requires inpatient or day hospital treatment
  • Diagnosed with substance dependence within the last three months
  • Inability to read self-report instruments
  • History of seizures
  • Current primary diagnosis of Bipolar Disorder I or II

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Social Cognition Assessment and Training
Assessment and training program to enhance social function
Behavioral: Social Cognition Assessment and Training
The study includes an assessment and treatment phase: The assessment phase will test the efficacy and feasibility of a battery of measures evaluating social cognition and behavior. Functional magnetic resonance imaging (fMRI) will also be used to investigate functional differences in regions of the brain associated with social cognition and differences in cognitive progressing. The treatment phase will assess the efficacy and feasibility of a strategy-based social skills treatment using a virtual reality platform.
Other Names:
  • Virtual Reality Social Cognition Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Activation Change: Social Cognitive Network
Time Frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
To examine activation change in the brain as a result of treatment on fMRI measures to further understand the mechanism and predictors of change in young adults with social impairment.
Change from Pre-training (prior to treatment) to Post-training (immediately following training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropsychological Scores: Recognizing Emotion
Time Frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
To examine effects after treatment on the social cognitive skill to recognize emotion
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Theory of Mind
Time Frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
To examine effects after treatment on the social cognitive skill to have theory of mind, understand other's thought and intentions
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Behavior
Time Frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
To examine effects after treatment on outward social behavior
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Functioning
Time Frame: Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)
To examine effects after treatment on daily-life social functioning and social engagement
Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Dallas

Collaborators

Yale University
University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Sandra B Chapman, Ph.D., Center for BrainHealth, UT Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU 042011-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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