Using Immersive Virtual Reality to Treat Pediatric Anxiety

Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Specific Phobia; Specific Phobia, Animal; Specific Phobia, Situational; Specific Phobia, Natural Environment; Childhood Anxiety Disorder
• Intervention / Treatment: Behavioral: Virtual Reality Exposure Therapy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Exposure Therapy; 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; Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Joseph F. McGuire, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): January 12, 2022
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Exposure Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: IRB00210075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No