Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Pegasys-VR; Social Effectiveness Therapy for Children
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.; Group social skills training, peer generalization sessions, individual exposure therapy
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phobic disorders; anxiety disorders