Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety

Anxiety Disorders Clinical Trial

Official title:

Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816684
• Other study ID #: 5R42MH094019-05
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of social anxiety disorder

Exclusion Criteria:

• an IQ < 85 and/or the presence of comorbid conduct disorder, bipolar disorder, severe depression, suicidal ideation, ADHD, developmental disorders or psychotic disorders

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Pegasys-VR
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 Children
Group social skills training, peer generalization sessions, individual exposure therapy

Locations

Country	Name	City	State
United States	UCF RESTORES, University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	Virtually Better, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Phobia and Anxiety Inventory for Children	self-report measure of social anxiety disorder in children	Change from baseline at 12 weeks
Secondary	Diagnosis of Social Anxiety Disorder	assigned at completion of the diagnostic interview	12 weeks
Secondary	Child Behavior Checklist	parental assessment of child functioning	Change from baseline at 12 weeks
Secondary	Child Global Assessment of Functioning	clinician assessment of child functioning	change from baseline at 12 weeks
Secondary	Clinical Global Improvement Scale	clinician assessment of child improvement	change from baseline at 12 weeks
Secondary	Behavioral Assessment	direct observation of child social skill	change from baseline at 12 weeks