Using Immersive Virtual Reality to Treat Pediatric Anxiety

NCT04504773 | Completed

• 1 other identifier: IRB00210075
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Exposure Therapy; Virtual Reality

Outcome Measures

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.

  1 week after virtual reality exposure therapy session

Secondary Outcomes (1)

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

  1 week after virtual reality exposure therapy session

Study Arms (1)

Virtual Reality Exposure Therapy

EXPERIMENTAL

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

Virtual Reality Exposure Therapy BEHAVIORAL

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

Virtual Reality Exposure Therapy

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Phobia, Specific

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joseph F. McGuire, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessor is not involved in treatment, and will assess the severity of the participants anxiety.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: September 17, 2020
• Primary Completion: January 12, 2022
• Study Completion: February 14, 2023
• Last Updated: February 21, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)