Skip to main content
OpenTrials
Completed

NCT Number: NCT04504773

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

virtual reality exposure therapy

Behavioral

Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.

Primary outcomes

  1. Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)

    Time frame: 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 outcomes

  1. Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 7, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.