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CompletedNCT04504773Updated Feb 21, 2023

Using Immersive Virtual Reality to Treat Pediatric Anxiety

An interventional study of Virtual Reality Exposure Therapy in Specific Phobia, Specific Phobia, Situational and Specific Phobia, Animal, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
8 Years to 17 Years
Sex
All
01

Study 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.

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Conditions studied

  • Specific Phobia
  • Specific Phobia, Situational
  • Specific Phobia, Animal
  • Specific Phobia, Natural Environment
  • Childhood Anxiety Disorder

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Keywords

  • Exposure Therapy
  • Virtual Reality
03

In context

Phobia, Specific

85 studies on the registry are indexed under Phobia, Specific; 13 are open to participants now.

This study's enrollment of 3 is below the median of 74 across 81 interventional studies indexed under Phobia, Specific.

Browse Phobia, Specific studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • unable to complete rating scales, or
  • attend study visits.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralVirtual Reality Exposure Therapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week after virtual reality exposure therapy session

Secondary outcomes

  1. 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.

    Time frame: 1 week after virtual reality exposure therapy session

07

Study locations

1 site
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21205, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Jan 2022, 15 months.

Of 48 non-industry interventional studies with no phase under Phobia, Specific, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 15 months is below that.

Counting every sponsor, half of 49 studies reached it within 28 months; a quarter within 11 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2020
First posted
Aug 7, 2020
StartActual
Sep 17, 2020
Primary completionActual
Jan 12, 2022
CompletionActual
Feb 14, 2023
Last update
Feb 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04504773
Responsible party
Sponsor
First posted
Aug 7, 2020
Start date
Sep 17, 2020
Primary completion
Jan 12, 2022
Completion
Feb 14, 2023
Last update
Feb 21, 2023

Study contacts

Joseph F. McGuire, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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