- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816684
Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety
October 18, 2018 updated by: University of Central Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- UCF RESTORES, University of Central Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SET-C
Social Effectiveness Therapy for Children (SET-C; Beidel et al., 2000) includes social skills training, peer generalization experiences, and in vivo exposure.
|
Group social skills training, peer generalization sessions, individual exposure therapy
|
Experimental: Pegasys-VR
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.
|
Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Phobia and Anxiety Inventory for Children
Time Frame: Change from baseline at 12 weeks
|
self-report measure of social anxiety disorder in children
|
Change from baseline at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Social Anxiety Disorder
Time Frame: 12 weeks
|
assigned at completion of the diagnostic interview
|
12 weeks
|
Child Behavior Checklist
Time Frame: Change from baseline at 12 weeks
|
parental assessment of child functioning
|
Change from baseline at 12 weeks
|
Child Global Assessment of Functioning
Time Frame: change from baseline at 12 weeks
|
clinician assessment of child functioning
|
change from baseline at 12 weeks
|
Clinical Global Improvement Scale
Time Frame: change from baseline at 12 weeks
|
clinician assessment of child improvement
|
change from baseline at 12 weeks
|
Behavioral Assessment
Time Frame: change from baseline at 12 weeks
|
direct observation of child social skill
|
change from baseline at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deborah C Beidel, Ph.D., University of Central Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 24, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Actual)
October 19, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R42MH094019-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Disorders
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
-
Loma Linda UniversityCompletedParental/Caregiver Anxiety | Child's AnxietyUnited States
Clinical Trials on Social Effectiveness Therapy for Children
-
University of WashingtonNational Center for Advancing Translational Sciences (NCATS)Not yet recruitingParenting | Mental Health Wellness 1 | Well-Being, Psychological
-
Heidelberg UniversityGerman Association for Systemic Therapy, Counseling and Family Therapy (DGSF) and other collaboratorsCompletedSocial Anxiety DisorderGermany
-
Weill Medical College of Cornell UniversityGreen Chimneys Residential Treatment Center, Brewster, NYCompletedChildhood AggressionUnited States
-
Istanbul Bilgi UniversityThe Scientific and Technological Research Council of Turkey; Anna Freud National...Active, not recruitingMental Disorder, ChildTurkey
-
Biruni UniversityRecruiting
-
University of ManchesterManchester University NHS Foundation TrustCompletedSocial Anxiety | Social Anxiety Disorder | Social PhobiaUnited Kingdom
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingConduct Disorder | Autism-Spectrum DisorderSwitzerland
-
Damascus UniversityCompletedDental Plaque | Dental Care | Dental ProphylaxisSyrian Arab Republic
-
University of OklahomaUniversity of TulsaRecruitingSuicidal Ideation | Children, Only | NightmareUnited States
-
Boston University Charles River CampusNational Institute of Mental Health (NIMH)CompletedDepressive Disorder | Anxiety DisordersUnited States