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Using Immersive Virtual Reality to Treat Pediatric Anxiety

Primary Purpose

Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring Exposure Therapy, Virtual Reality

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Exposure Therapy

Arm Description

Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 5, 2020
Last Updated
February 20, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04504773
Brief Title
Using Immersive Virtual Reality to Treat Pediatric Anxiety
Official Title
Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Specific Phobia, Situational, Specific Phobia, Animal, Specific Phobia, Natural Environment, Childhood Anxiety Disorder
Keywords
Exposure Therapy, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Exposure Therapy
Arm Type
Experimental
Arm Description
Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
Primary Outcome Measure Information:
Title
Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)
Description
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.
Time Frame
1 week after virtual reality exposure therapy session
Secondary Outcome Measure Information:
Title
Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)
Description
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.
Time Frame
1 week after virtual reality exposure therapy session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F. McGuire, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Immersive Virtual Reality to Treat Pediatric Anxiety

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