NCT02922400

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

9.8 years

First QC Date

September 29, 2016

Last Update Submit

May 2, 2018

Conditions

Keywords

AutismTraumatic Brain InjurySchizophreniaVirtual-Reality Social Cognition Training

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

EXPERIMENTAL

Assessment and training program to enhance social function

Behavioral: Social Cognition Assessment and Training

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.

Also known as: Virtual Reality Social Cognition Training
Social Cognition Assessment and Training

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Center for BrainHealth University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Autistic DisorderBrain Injuries, TraumaticSchizophrenia

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Sandra B Chapman, Ph.D.

    Center for BrainHealth, UT Dallas

    PRINCIPAL INVESTIGATOR

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

Locations