Cognitive Function 1, Social Clinical Trial
Official title:
Social Cognition Assessment in Young Adults
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.
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.
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