Social Cognition Assessment in Young Adults
1 other identifier
interventional
153
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 29, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMay 8, 2018
May 1, 2018
9.8 years
September 29, 2016
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in Neuropsychological Scores: Recognizing Emotion
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Theory of Mind
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Behavior
Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Functioning
Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)
Study Arms (1)
Social Cognition Assessment and Training
EXPERIMENTALAssessment and training program to enhance social function
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas at Dallaslead
- University of Texas Southwestern Medical Centercollaborator
- Yale Universitycollaborator
Study Sites (1)
Center for BrainHealth University of Texas at Dallas
Dallas, Texas, 75235, United States
Related Publications (4)
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.
PMID: 22570145RESULTDidehbani 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.
PMID: 22527705RESULTDidehbani 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.
PMID: 23043874RESULTKrawczyk 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.
PMID: 25191240RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra B Chapman, Ph.D.
Center for BrainHealth, UT Dallas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2016
First Posted
October 4, 2016
Study Start
November 1, 2006
Primary Completion
September 1, 2016
Study Completion
January 1, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share