Clinical trial NCT05839431: Virtual Reality for Youth Phobias
Official title: Virtual Reality for Youth Phobias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Social Anxiety Disorder
Autism Spectrum Disorder
Keywords: Virtual Reality
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
First posted: 2023-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Change in social anxiety as measured by the Severity Measure for Social Anxiety Disorder (Social Phobia)
timeFrame: Baseline, 10 weeks
measure: Change in social anxiety as measured by the Severity Measure for Specific Phobia
timeFrame: Baseline, 10 weeks
measure: Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale for Children
timeFrame: Baseline, 10 weeks
measure: Change in family accommodation as measured by the Family Accommodation Scale-Anxiety
timeFrame: Baseline, 10 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, PhD
role: PRINCIPAL_INVESTIGATOR
References: