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

NCT02816684 | Completed Phase 2 DMC

• 1 other identifier: 5R42MH094019-05
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

phobic disorders; anxiety disorders

Outcome Measures

Primary Outcomes (1)

• Social Phobia and Anxiety Inventory for Children

  self-report measure of social anxiety disorder in children

  Change from baseline at 12 weeks

Secondary Outcomes (5)

• Diagnosis of Social Anxiety Disorder

  12 weeks

• Child Behavior Checklist

  Change from baseline at 12 weeks

• Child Global Assessment of Functioning

  change from baseline at 12 weeks

• Clinical Global Improvement Scale

  change from baseline at 12 weeks

• Behavioral Assessment

  change from baseline at 12 weeks

Study Arms (2)

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.

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.

Behavioral: Pegasys-VR

Interventions

Pegasys-VR BEHAVIORAL

Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.

Pegasys-VR

Social Effectiveness Therapy for Children BEHAVIORAL

Group social skills training, peer generalization sessions, individual exposure therapy

SET-C

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of social anxiety disorder

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Florida: lead
• Virtually Better, Inc.: collaborator

Study Sites (1)

UCF RESTORES, University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Deborah C Beidel, Ph.D.

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)