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Cognitive Function 1, SocialNCT02922400

Social Cognition Assessment in Young Adults

A study testing Social Cognition Assessment and Training in people with Cognitive Function 1, Social, run by The University of Texas at Dallas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 17 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function 1, Social
What is being tested?
Social Cognition Assessment and Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteUnited States
Study dates
Nov 2006to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for BrainHealth University of Texas at Dallas

    Dallas, Texas, 75235

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Social Cognition Assessment and Training
Keywords
Autism, Traumatic Brain Injury, Schizophrenia, Virtual-Reality Social Cognition Training
Medical subject headings
Autistic Disorder, Brain Injuries, Traumatic, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Cognition Assessment and TrainingBehavioural

    Also called Virtual Reality Social Cognition 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.

Study groups in NCT02922400
Study groupRoleWhat they receive
Social Cognition Assessment and TrainingExperimentalAssessment and training program to enhance social function
Receives: Behavioral: Social Cognition Assessment and Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Pre-training (prior to treatment) to Post-training (immediately following training)

Secondary outcomes (4)
  1. Change in Neuropsychological Scores: Recognizing Emotion

    To examine effects after treatment on the social cognitive skill to recognize emotion

    Measured: Change from Pre-training (prior to treatment) to Post-training (immediately following training)

  2. 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

    Measured: Change from Pre-training (prior to treatment) to Post-training (immediately following training)

  3. Change in Neuropsychological Scores: Social Behavior

    To examine effects after treatment on outward social behavior

    Measured: Change from Pre-training (prior to treatment) to Post-training (immediately following training)

  4. Change in Neuropsychological Scores: Social Functioning

    To examine effects after treatment on daily-life social functioning and social engagement

    Measured: Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study startNov 2006
  3. Primary completionSep 2016
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922400
Sponsor's protocol ID
STU 042011-021
Status last verified
May 2018
First submitted
29 Sep 2016
Last updated
8 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22570145
  • 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.

    PubMed 22527705
  • 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.

    PubMed 23043874
  • 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.

    PubMed 25191240

Questions about this trial

What is this clinical trial studying?

A study testing Social Cognition Assessment and Training in people with Cognitive Function 1, Social, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Activation Change: Social Cognitive Network (time frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922400, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.

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