ClinicalTrials.gg
CompletedNCT05839431Updated Jul 19, 2024

Virtual Reality for Youth Phobias

An interventional study of Virtual Reality for Youth Phobias in Specific Phobia, Social Anxiety Disorder and Autism Spectrum Disorder, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Specific Phobia
  • Social Anxiety Disorder
  • Autism Spectrum Disorder

Keywords

  • 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 10 is below the median of 74 across 81 interventional studies indexed under Phobia, Specific.

Browse Phobia, Specific studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

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

04

Who can participate

Ages eligible
8 Years and older
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

  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 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

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 (to not delay intervention).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

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

Study arms

  • 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

Interventions

  • BehavioralVirtual 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.

06

What researchers measure

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.

    Time frame: Up to 10 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, 10 weeks

  2. 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.

    Time frame: Baseline, 10 weeks

  3. 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.

    Time frame: Baseline, 10 weeks

  4. 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.

    Time frame: Baseline, 10 weeks

07

Study locations

1 site
  • University of Miami
    Coral Gables, Florida 33146, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05839431
Collaborators
The Children's Trust, Miami FL
Responsible party
Jill May Ehrenreich (Professor, University of Miami) — Principal investigator
First posted
May 3, 2023
Start date
Jul 14, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Jul 19, 2024

Study contacts

Jill Ehrenreich-May, PhD
principal investigator · University of Miami

Oversight

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

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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