Virtual Reality for Youth Phobias

The purpose of this study is to examine the effectiveness of virtual reality (VR) delivered exposure therapy for youth with phobias or social anxiety, with and without autism spectrum disorder. The study team is also interested in collecting information to better understand phobias and social anxiety.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Social Anxiety Disorder; Specific Phobia
• Intervention / Treatment: Behavioral: Virtual Reality for Youth Phobias

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The target population for this project are 48 youth (ages of 8-16) that meet criteria for a specific phobia or social anxiety disorder within Miami-Dade County.
2. Youth will be eligible if they or their parent report clinically significant symptoms of social anxiety disorder or a specific phobia targeted with the VR program, based on self- or parent-report scores on online screening measures (>1 average total scores on Severity Measure for Specific Phobia-Child or Social Anxiety Disorder-Child) or clinician-report diagnosis (i.e., diagnosed with Social Anxiety Disorder or Specific Phobia during clinical interview).
3. Youth are able to complete study procedures, speak/read English or Spanish sufficiently.
4. Youth have at least one caregiver who can complete all study measures in English or Spanish.
5. Youth have a caregiver who is available to sign study consent forms, remain present during assessments, and fill out study questionnaires.

Exclusion Criteria:

1. Youth who would be inappropriate for a brief VR-exposure therapy protocol will be referred to local resources for additional support or provided with alternate cognitive behavioral therapy services through the clinical center in which this program takes place.
2. Research staff will review all measures and the youth's psychological history and consult with the PI to ensure that the participant does not have a current diagnosis of psychosis, bipolar disorder, acute suicidality, alcohol/substance dependence, or eating disorder.
3. Youth will also be excluded if they are currently receiving psychotherapy elsewhere.
4. Youth with co-occurring intellectual disability may be eligible, but youth who are non-verbal will not be eligible, as some verbal abilities are necessary in order to communicate with the clinician during the intervention.
5. Youth who are currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded (or discussed on a case-by-case basis).
6. Youth who engage in self-harm behaviors (e.g., cutting) and who do not present with suicidal intent will be allowed to participate.
7. If youth develop psychiatric problems (e.g., severe depression, acute suicidal ideation/intent, severe conduct problems) that require a higher level of care, youth will be withdrawn from the study and referred for appropriate treatment.
8. Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay intervention).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Therapy for Youth Phobias; Participants will undergo up to 10 weeks of virtual reality-assisted exposure therapy.	Behavioral: Virtual Reality for Youth Phobias; The intervention will consist of up to 10, 50-minute-long weekly in-person individual sessions of virtual reality-assisted exposure therapy. This intervention also includes psychoeducation about anxiety/phobias and their maintenance, youth strategies for tolerating distress, and parent strategies for reducing accommodation of anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire is an 8-item measure of client satisfaction with services with both a parent and child version. The total scores range from 8 to 32, with higher scores indicating higher satisfaction.	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social anxiety as measured by the Severity Measure for Social Anxiety Disorder (Social Phobia)	The Severity Measure for Social Anxiety Disorder (Social Phobia)-Child is a 10-item measure that assesses the severity of symptoms of social anxiety (social phobia) in children and adolescents over the last 7 days. Scores range from 0 to 4. An average total score of 2 or greater indicates at least moderate social anxiety.	Baseline, 10 weeks
Change in social anxiety as measured by the Severity Measure for Specific Phobia	The Severity Measure for Specific Phobia-Child is a 10-item measure that assesses the severity of symptoms of specific phobias in children and adolescents, including those targeted by the VR programs, over the last 7 days. Scores range from 0 to 4. An average total score of 2 or greater indicates at least moderate phobia symptoms.	Baseline, 10 weeks
Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale for Children	The Intolerance of Uncertainty Scale for Children 12-item child and parent report of the tendency to react negatively on an emotional, cognitive, and/or behavioral level to uncertain situations and events. Scores range from 12 to 60. Higher scores indicate greater intolerance of uncertainty.	Baseline, 10 weeks
Change in family accommodation as measured by the Family Accommodation Scale-Anxiety	The Family Accommodation Scale-Anxiety is a 9-item scale of measuring caregiver accommodation behaviors (modification of routines, facilitating avoidance, etc.) in light of youth anxiety. Scores range from 0 to 36. Higher scores indicate greater family accommodation.	Baseline, 10 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Children's Trust, Miami FL
• Investigators: Principal Investigator: Jill Ehrenreich-May, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Anxiety Disorders; Autism Spectrum Disorder; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: 20221240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No