Clinical trial NCT02922400: Social Cognition Assessment in Young Adults
Official title: Social Cognition Assessment in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function 1, Social
Keywords: Autism
Traumatic Brain Injury
Schizophrenia
Virtual-Reality Social Cognition Training
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Yale University
First posted: 2016-10-04
Enrollment: 153
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain Activation Change: Social Cognitive Network
timeFrame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Secondary outcomes:
measure: Change in Neuropsychological Scores: Recognizing Emotion
timeFrame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
measure: Change in Neuropsychological Scores: Theory of Mind
timeFrame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
measure: Change in Neuropsychological Scores: Social Behavior
timeFrame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
measure: Change in Neuropsychological Scores: Social Functioning
timeFrame: Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Center for BrainHealth University of Texas at Dallas
state: Texas
Study officials:
affiliation: Center for BrainHealth, UT Dallas
name: Sandra B Chapman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kandalaft MR, Didehbani N, Krawczyk DC, Allen TT, Chapman SB. Virtual reality social cognition training for young adults with high-functioning autism. J Autism Dev Disord. 2013 Jan;43(1):34-44. doi: 10.1007/s10803-012-1544-6.
citation: Didehbani N, Shad MU, Kandalaft MR, Allen TT, Tamminga CA, Krawczyk DC, Chapman SB. Brief report: Insight into illness and social attributional style in Asperger's syndrome. J Autism Dev Disord. 2012 Dec;42(12):2754-60. doi: 10.1007/s10803-012-1532-x.
citation: Didehbani N, Shad MU, Tamminga CA, Kandalaft MR, Allen TT, Chapman SB, Krawczyk DC. Insight and empathy in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):246-7. doi: 10.1016/j.schres.2012.09.010. Epub 2012 Oct 6. No abstract available.
citation: Krawczyk DC, Kandalaft MR, Didehbani N, Allen TT, McClelland MM, Tamminga CA, Chapman SB. An investigation of reasoning by analogy in schizophrenia and autism spectrum disorder. Front Hum Neurosci. 2014 Aug 20;8:517. doi: 10.3389/fnhum.2014.00517. eCollection 2014.