Anxiety DisordersPhase 2NCT02816684
Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
A Phase 2 study testing Pegasys-VR and Social Effectiveness Therapy for Children in people with Anxiety Disorders, run by University of Central Florida at 1 site in United States.
Trial summary
Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness Therapy for Children (SET-C) is an empirically supported treatment with significant potential to impact the lives of children with this severe and chronic disorder. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Pegasys-VR and Social Effectiveness Therapy for Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2018
- Phase
- Phase 2
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of social anxiety disorder
Who cannot join
- an IQ < 85 and/or the presence of comorbid conduct disorder, bipolar disorder, severe depression, suicidal ideation, ADHD, developmental disorders or psychotic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
UCF RESTORES, University of Central Florida
Orlando, Florida, 32816
About this study
Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness Therapy for Children (SET-C) is an empirically supported treatment with significant potential to impact the lives of children with this severe and chronic disorder. The proposed Pegasys-VR™ system will distinctly enhance its utility, as it will allow dissemination to a broad variety of clinical settings including schools as well as traditional outpatient clinics. Its use for the treatment of social skills deficits will offer a superior solution for mental health personnel, solving many of the resource and logistic barriers that they currently face. The final product will address cost and practical issues by disseminating an empirically-supported treatment that was rigorously built and tested. Using VE will make the traditional social skills therapy programs program cost-effective and patient-centric, allowing even clinicians with little background/training in behavior therapy to have tools not typically available to them.
Read the detailed description
Anxiety disorders are the most common psychiatric disorders among youth, with lifetime prevalence ranging between 18-20% of the general population. Among anxiety disorders, social anxiety disorder (SAD) affects 8% of all youth, resulting in significant short and long-term impairment, including increased likelihood of substance abuse, limited academic achievement, attenuated occupational functioning, and impaired or missing social relationships. Emerging data suggest that interventions that include social skills training, formal peer generalization sessions, and homework assignments as part of an overall treatment strategy show enhanced efficacy when compared to interventions without these components - the latter two elements which are designed to enhance skill generalization. Two critical treatment elements (peer generalization, homework assignments) are difficult to implement in traditional clinical settings, limiting optimal dissemination to youth in need of these services in different settings (e.g., at school, outpatient, or community facilities). In a recently completed Phase I STTR, the investigators developed and validated an interactive virtual environment (VE) to solve the need for intensive behavioral practice opportunities that are critical for skill generalization. The VE, known as Pegasys-VR™, allowed intensive practice of social skills without the need for formal peer group activities (in clinic solution) or intensive parental involvement (at-home solution). The results indicated that implementing a VE environment into the SET-C program was accessible, credible and feasible for the parents, clinicians and children who participated in the trial. Furthermore, examination of within group changes indicated statistically significant improvement in SAD symptoms. Given the success of the Phase I, and the need to increase the automation of the system to increase its acceptance and adoption among clinicians and socially anxiety youth, the Phase II STTR study will have the following goals: incorporate an artificial intelligence natural language system, develop additional VEs for in-clinic practice, expand the homework solution to provide additional opportunities to reinforce skills acquisition and generalization practice in in-vivo settings, using serious game theory and technology, and conduct a randomized controlled trial with youth ages 7 to 12 to test whether Pegasys-VR™ is as effective as a traditional behavioral interventions for youth with social anxiety disorder and if the effects are maintained at 3 month follow-up. If Pegasys-VR™ is clinically efficacious, it would offer a sustainable, cost-effective intervention that can be easily and rapidly disseminated.
- Conditions
- Anxiety Disorders
- Being tested
- Pegasys-VR, Social Effectiveness Therapy for Children
- Keywords
- phobic disorders, anxiety disorders
- Medical subject headings
- Anxiety Disorders, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegasys-VRBehavioural
Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.
Social Effectiveness Therapy for ChildrenBehavioural
Group social skills training, peer generalization sessions, individual exposure therapy
| Study group | Role | What they receive |
|---|---|---|
| SET-C | Active comparator | Social Effectiveness Therapy for Children (SET-C; Beidel et al., 2000) includes social skills training, peer generalization experiences, and in vivo exposure. Receives: Behavioral: Social Effectiveness Therapy for Children |
| Pegasys-VR | Experimental | SET-C SST and individual exposure sessions are the same as the active comparator. Peer generalization sessions are replaced by a virtual environment, known as Pegasys School. children engage with artificially intelligent avatars throughout the school. Receives: Behavioral: Pegasys-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia and Anxiety Inventory for Children
self-report measure of social anxiety disorder in children
Measured: Change from baseline at 12 weeks
Secondary outcomes (5)
Diagnosis of Social Anxiety Disorder
assigned at completion of the diagnostic interview
Measured: 12 weeks
Child Behavior Checklist
parental assessment of child functioning
Measured: Change from baseline at 12 weeks
Child Global Assessment of Functioning
clinician assessment of child functioning
Measured: change from baseline at 12 weeks
Clinical Global Improvement Scale
clinician assessment of child improvement
Measured: change from baseline at 12 weeks
Behavioral Assessment
direct observation of child social skill
Measured: change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Virtually Better, Inc.
- Responsible party
- Sponsor
- Investigators
- Deborah C Beidel, Ph.D., Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816684
- Sponsor's protocol ID
- 5R42MH094019-05
- Status last verified
- Oct 2018
- First submitted
- 20 Jun 2016
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
- ClinicalTrials.gov ID
- NCT02816684
- Acronym / sponsor ID
- 5R42MH094019-05
- Conditions
- Anxiety Disorders
- Keywords
- phobic disorders, anxiety disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Virtually Better, Inc.
- Study start
- Jun 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 28 Jun 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.
Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness Therapy for Children (SET-C) is an empirically supported treatment with significant potential to impact the lives of children with this severe and chronic disorder. The proposed Pegasys-VR™ system will distinctly enhance its utility, as it will allow dissemination to a broad variety of clinical settings including schools as well as traditional outpatient clinics. Its use for the treatment of social skills deficits will offer a superior solution for mental health personnel, solving many of the resource and logistic barriers that they currently face. The final product will address cost and practical issues by disseminating an empirically-supported treatment that was rigorously built and tested. Using VE will make the traditional social skills therapy programs program cost-effective and patient-centric, allowing even clinicians with little background/training in behavior therapy to have tools not typically available to them.
Detailed description
Anxiety disorders are the most common psychiatric disorders among youth, with lifetime prevalence ranging between 18-20% of the general population. Among anxiety disorders, social anxiety disorder (SAD) affects 8% of all youth, resulting in significant short and long-term impairment, including increased likelihood of substance abuse, limited academic achievement, attenuated occupational functioning, and impaired or missing social relationships. Emerging data suggest that interventions that include social skills training, formal peer generalization sessions, and homework assignments as part of an overall treatment strategy show enhanced efficacy when compared to interventions without these components - the latter two elements which are designed to enhance skill generalization. Two critical treatment elements (peer generalization, homework assignments) are difficult to implement in traditional clinical settings, limiting optimal dissemination to youth in need of these services in different settings (e.g., at school, outpatient, or community facilities). In a recently completed Phase I STTR, the investigators developed and validated an interactive virtual environment (VE) to solve the need for intensive behavioral practice opportunities that are critical for skill generalization. The VE, known as Pegasys-VR™, allowed intensive practice of social skills without the need for formal peer group activities (in clinic solution) or intensive parental involvement (at-home solution). The results indicated that implementing a VE environment into the SET-C program was accessible, credible and feasible for the parents, clinicians and children who participated in the trial. Furthermore, examination of within group changes indicated statistically significant improvement in SAD symptoms. Given the success of the Phase I, and the need to increase the automation of the system to increase its acceptance and adoption among clinicians and socially anxiety youth, the Phase II STTR study will have the following goals: incorporate an artificial intelligence natural language system, develop additional VEs for in-clinic practice, expand the homework solution to provide additional opportunities to reinforce skills acquisition and generalization practice in in-vivo settings, using serious game theory and technology, and conduct a randomized controlled trial with youth ages 7 to 12 to test whether Pegasys-VR™ is as effective as a traditional behavioral interventions for youth with social anxiety disorder and if the effects are maintained at 3 month follow-up. If Pegasys-VR™ is clinically efficacious, it would offer a sustainable, cost-effective intervention that can be easily and rapidly disseminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SET-C | Active comparator | Behavioral: Social Effectiveness Therapy for ChildrenSocial Effectiveness Therapy for Children (SET-C; Beidel et al., 2000) includes social skills training, peer generalization experiences, and in vivo exposure. |
| Pegasys-VR | Experimental | Behavioral: Pegasys-VRSET-C SST and individual exposure sessions are the same as the active comparator. Peer generalization sessions are replaced by a virtual environment, known as Pegasys School. children engage with artificially intelligent avatars throughout the school. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of social anxiety disorder
Key exclusion criteria (1 listed)
- an IQ < 85 and/or the presence of comorbid conduct disorder, bipolar disorder, severe depression, suicidal ideation, ADHD, developmental disorders or psychotic disorders
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 |
|---|---|---|
| Pegasys-VRPegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills. | Behavioural | Pegasys-VR |
| Social Effectiveness Therapy for ChildrenGroup social skills training, peer generalization sessions, individual exposure therapy | Behavioural | SET-C |
Primary outcome
Social Phobia and Anxiety Inventory for Children
Time frame: Change from baseline at 12 weeks
self-report measure of social anxiety disorder in children
5 secondary outcomes
Diagnosis of Social Anxiety Disorder
Time frame: 12 weeks
Child Behavior Checklist
Time frame: Change from baseline at 12 weeks
Child Global Assessment of Functioning
Time frame: change from baseline at 12 weeks
Clinical Global Improvement Scale
Time frame: change from baseline at 12 weeks
Behavioral Assessment
Time frame: change from baseline at 12 weeks
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 19 Oct 2018.
- 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.
Deborah C Beidel, Ph.D. principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegasys-VR and Social Effectiveness Therapy for Children in people with Anxiety Disorders, run by University of Central Florida 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 1 inclusion and 1 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 19 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Social Phobia and Anxiety Inventory for Children (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2018.