Virtual Reality for Youth Phobias

NCT05839431 | Completed

• 1 other identifier: 20221240
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Specific Phobia; Social Anxiety Disorder; Autism Spectrum Disorder

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in social anxiety as measured by the Severity Measure for Social Anxiety Disorder (Social Phobia)

  Baseline, 10 weeks

• Change in social anxiety as measured by the Severity Measure for Specific Phobia

  Baseline, 10 weeks

• Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale for Children

  Baseline, 10 weeks

• Change in family accommodation as measured by the Family Accommodation Scale-Anxiety

  Baseline, 10 weeks

Study Arms (1)

Virtual Reality Therapy for Youth Phobias

EXPERIMENTAL

Participants will undergo up to 10 weeks of virtual reality-assisted exposure therapy.

Behavioral: Virtual Reality for Youth Phobias

Interventions

Virtual Reality for Youth Phobias BEHAVIORAL

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.

Virtual Reality Therapy for Youth Phobias

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Youth are able to complete study procedures, speak/read English or Spanish sufficiently.
• Youth have at least one caregiver who can complete all study measures in English or Spanish.
• Youth have a caregiver who is available to sign study consent forms, remain present during assessments, and fill out study questionnaires.

You may not qualify if:

• 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.
• 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.
• Youth will also be excluded if they are currently receiving psychotherapy elsewhere.
• 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.
• 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).
• Youth who engage in self-harm behaviors (e.g., cutting) and who do not present with suicidal intent will be allowed to participate.
• 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.
• Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay intervention).

Sponsors & Collaborators

• University of Miami: lead
• The Children's Trust, Miami FL: collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Phobia, Specific; Phobia, Social; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: July 14, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)