Using Immersive Virtual Reality to Treat Pediatric Anxiety

Sponsor

Johns Hopkins University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04504773

Collaborator

(none)

Enrollment

Location

Arm

26.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Specific Phobia Specific Phobia, Situational Specific Phobia, Animal Specific Phobia, Natural Environment Childhood Anxiety Disorder	Behavioral: Virtual Reality Exposure Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Outcomes assessor is not involved in treatment, and will assess the severity of the participants anxiety.

Primary Purpose:

Treatment

Official Title:

Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety

Actual Study Start Date :

Sep 17, 2020

Actual Primary Completion Date :

Jan 12, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P) [1 week after virtual reality exposure therapy session]
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.

Secondary Outcome Measures

Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P) [1 week after virtual reality exposure therapy session]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04504773

Other Study ID Numbers:

IRB00210075

First Posted:

Aug 7, 2020

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johns Hopkins University

Exposure Therapy

Virtual Reality

Additional relevant MeSH terms:

Anxiety Disorders

Phobic Disorders

Study Results

No Results Posted as of Jun 10, 2022