Cognitive Function 1, Social Clinical Trial
Official title:
Social Cognition Assessment in Young Adults
Verified date | May 2018 |
Source | The University of Texas at Dallas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 153 |
Est. completion date | January 2018 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Center for BrainHealth University of Texas at Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at Dallas | University of Texas Southwestern Medical Center, Yale University |
United States,
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. — View 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. — View 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. — View 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. eCollec — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain Activation Change: Social Cognitive Network | 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 | Change in Neuropsychological Scores: Recognizing Emotion | 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) | |
Secondary | Change in Neuropsychological Scores: Theory of Mind | 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) | |
Secondary | Change in Neuropsychological Scores: Social Behavior | To examine effects after treatment on outward social behavior | Change from Pre-training (prior to treatment) to Post-training (immediately following training) | |
Secondary | Change in Neuropsychological Scores: Social Functioning | 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) |
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