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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02922400
Other study ID # STU 042011-021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2006
Est. completion date January 2018

Study information

Verified date May 2018
Source The University of Texas at Dallas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Center for BrainHealth University of Texas at Dallas Dallas Texas

Sponsors (3)

Lead Sponsor Collaborator
The University of Texas at Dallas University of Texas Southwestern Medical Center, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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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