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临床试验/NCT05839431
NCT05839431已完成不适用

Virtual Reality for Youth Phobias

University of Miami2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: Up to 10 weeks

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.

次要结局

  • 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 social anxiety as measured by the Severity Measure for Social Anxiety Disorder (Social Phobia)(Baseline, 10 weeks)
  • Change in family accommodation as measured by the Family Accommodation Scale-Anxiety(Baseline, 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill May Ehrenreich

Professor

University of Miami

研究点 (2)

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