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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegasys-VR
Social Effectiveness Therapy for Children
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring phobic disorders, anxiety disorders

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCF RESTORES, University of Central Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SET-C

Pegasys-VR

Arm Description

Social Effectiveness Therapy for Children (SET-C; Beidel et al., 2000) includes social skills training, peer generalization experiences, and in vivo exposure.

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.

Outcomes

Primary Outcome Measures

Social Phobia and Anxiety Inventory for Children
self-report measure of social anxiety disorder in children

Secondary Outcome Measures

Diagnosis of Social Anxiety Disorder
assigned at completion of the diagnostic interview
Child Behavior Checklist
parental assessment of child functioning
Child Global Assessment of Functioning
clinician assessment of child functioning
Clinical Global Improvement Scale
clinician assessment of child improvement
Behavioral Assessment
direct observation of child social skill

Full Information

First Posted
June 20, 2016
Last Updated
October 18, 2018
Sponsor
University of Central Florida
Collaborators
Virtually Better, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02816684
Brief Title
Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
Official Title
Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
Virtually Better, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
phobic disorders, anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SET-C
Arm Type
Active Comparator
Arm Description
Social Effectiveness Therapy for Children (SET-C; Beidel et al., 2000) includes social skills training, peer generalization experiences, and in vivo exposure.
Arm Title
Pegasys-VR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pegasys-VR
Intervention Description
Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.
Intervention Type
Behavioral
Intervention Name(s)
Social Effectiveness Therapy for Children
Intervention Description
Group social skills training, peer generalization sessions, individual exposure therapy
Primary Outcome Measure Information:
Title
Social Phobia and Anxiety Inventory for Children
Description
self-report measure of social anxiety disorder in children
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Diagnosis of Social Anxiety Disorder
Description
assigned at completion of the diagnostic interview
Time Frame
12 weeks
Title
Child Behavior Checklist
Description
parental assessment of child functioning
Time Frame
Change from baseline at 12 weeks
Title
Child Global Assessment of Functioning
Description
clinician assessment of child functioning
Time Frame
change from baseline at 12 weeks
Title
Clinical Global Improvement Scale
Description
clinician assessment of child improvement
Time Frame
change from baseline at 12 weeks
Title
Behavioral Assessment
Description
direct observation of child social skill
Time Frame
change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah C Beidel, Ph.D.
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCF RESTORES, University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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