Using Immersive Virtual Reality to Treat Pediatric Anxiety

Study Overview
=================
Brief Summary
-----------------
Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.

Official Title
-----------------
Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety

Conditions
-----------------
Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal, Specific Phobia, Natural Environment, Childhood Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality Exposure Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8-17 years (inclusive), meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking). be fluent in English. Exclusion Criteria: unable to complete rating scales, or attend study visits.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Exposure Therapy<br>Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures. | Behavioral: Virtual Reality Exposure Therapy<br>* Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P) | The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder. | 1 week after virtual reality exposure therapy session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P) | Parent-reported rating of child anxiety that consists of 41-items. Items are rated on a 3-point scale that ranges from 0 (Not True) to 2 (Very True). The total score ranges from 0 to 82, with a total score of 25 or greater may indicate the presence of an anxiety disorder. | 1 week after virtual reality exposure therapy session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exposure Therapy, Virtual Reality