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Virtual Reality for Youth Phobias

Primary Purpose

Specific Phobia, Social Anxiety Disorder, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality for Youth Phobias
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring Virtual Reality

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Therapy for Youth Phobias

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 20, 2023
Last Updated
August 11, 2023
Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL
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1. Study Identification

Unique Protocol Identification Number
NCT05839431
Brief Title
Virtual Reality for Youth Phobias
Official Title
Virtual Reality for Youth Phobias
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Social Anxiety Disorder, Autism Spectrum Disorder
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Therapy for Youth Phobias
Arm Type
Experimental
Arm Description
Participants will undergo up to 10 weeks of virtual reality-assisted exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality for Youth Phobias
Intervention Description
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.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
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 Outcome Measure Information:
Title
Change in social anxiety as measured by the Severity Measure for Social Anxiety Disorder (Social Phobia)
Description
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
Title
Change in social anxiety as measured by the Severity Measure for Specific Phobia
Description
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
Title
Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale for Children
Description
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
Title
Change in family accommodation as measured by the Family Accommodation Scale-Anxiety
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Ehrenreich-May, PhD
Phone
305-284-6476
Email
j.ehrenreich@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Milgram, BA
Phone
305-284-9852
Email
camatprogram@miami.edu
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality for Youth Phobias

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