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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Cognitive Function 1, Social
- 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 group | Role | What they receive |
|---|---|---|
| Social Cognition Assessment and Training | Experimental | Assessment 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.
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)
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)
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)
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)
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.
- First posted4 Oct 2016 (estimated)
- Study startNov 2006
- Primary completionSep 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra B Chapman, Ph.D., Principal investigator, Center for BrainHealth, UT Dallas
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 22570145Didehbani 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 22527705Didehbani 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 23043874Krawczyk 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition Assessment in Young Adults
- ClinicalTrials.gov ID
- NCT02922400
- Acronym / sponsor ID
- STU 042011-021
- Conditions
- Cognitive Function 1, Social
- Keywords
- Autism, Traumatic Brain Injury, Schizophrenia, Virtual-Reality Social Cognition Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Yale University
- Study start
- Nov 2006
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Cognition Assessment and Training | Experimental | Behavioral: Social Cognition Assessment and TrainingAssessment and training program to enhance social function |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition Assessment and TrainingAlso: Virtual Reality Social Cognition TrainingThe 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. | Behavioural | Social Cognition Assessment and Training |
Primary outcome
Brain Activation Change: Social Cognitive Network
Time frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
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.
4 secondary outcomes
Change in Neuropsychological Scores: Recognizing Emotion
Time frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Theory of Mind
Time frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Behavior
Time frame: Change from Pre-training (prior to treatment) to Post-training (immediately following training)
Change in Neuropsychological Scores: Social Functioning
Time frame: Change from Pre-training (prior to treatment), to Post-training (immediately following training), and 3-Month follow-up (3 months following completion of training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Results publication: PubMed 22570145Kandalaft 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.
- Results publication: PubMed 22527705Didehbani 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.
- Results publication: PubMed 23043874Didehbani 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.
- Results publication: PubMed 25191240Krawczyk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra B Chapman, Ph.D. principal investigator
Center for BrainHealth, UT Dallas
1 site in 1 country: see every site and its status.
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.