<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04504773</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00210075</org_study_id>
    <nct_id>NCT04504773</nct_id>
  </id_info>
  <brief_title>Using Immersive Virtual Reality to Treat Pediatric Anxiety</brief_title>
  <official_title>Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety is a common and impairing problem for children. The principle treatment for pediatric&#xD;
      anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise&#xD;
      called exposures. While exposures are effective, some feared situations cannot be confronted&#xD;
      in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical&#xD;
      challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to&#xD;
      rely on imagined exposures, and/or (3) requires families to complete exposures outside of the&#xD;
      therapy visits. This creates a burden for clinicians and families, and impedes treatment&#xD;
      success. Immersive virtual reality (VR) presents an innovative solution that allows children&#xD;
      to face fears without leaving the clinician's office. While VR has been used to distract&#xD;
      children during painful medical procedures, it has not been well examined as a primary&#xD;
      treatment for pediatric anxiety. This study proposes to examine the effectiveness and&#xD;
      acceptability of using immersive VR exposures to treat children and adolescents with specific&#xD;
      phobias.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2020</start_date>
  <completion_date type="Actual">February 14, 2023</completion_date>
  <primary_completion_date type="Actual">January 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Outcomes assessor is not involved in treatment, and will assess the severity of the participants anxiety.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)</measure>
    <time_frame>1 week after virtual reality exposure therapy session</time_frame>
    <description>The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)</measure>
    <time_frame>1 week after virtual reality exposure therapy session</time_frame>
    <description>Parent-reported rating of child anxiety that consists of 41-items. Items are rated on a 3-point scale that ranges from 0 (Not True) to 2 (Very True). The total score ranges from 0 to 82, with a total score of 25 or greater may indicate the presence of an anxiety disorder.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Specific Phobia</condition>
  <condition>Specific Phobia, Situational</condition>
  <condition>Specific Phobia, Animal</condition>
  <condition>Specific Phobia, Natural Environment</condition>
  <condition>Childhood Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Virtual Reality Exposure Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality Exposure Therapy</intervention_name>
    <description>Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.</description>
    <arm_group_label>Virtual Reality Exposure Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8-17 years (inclusive),&#xD;
&#xD;
          -  meet diagnostic criteria for one or more phobias on a structured diagnostic interview&#xD;
             (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights)&#xD;
             and/or situational settings (e.g., airplanes, public speaking).&#xD;
&#xD;
          -  be fluent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to complete rating scales, or&#xD;
&#xD;
          -  attend study visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph F. McGuire, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exposure Therapy</keyword>
  <keyword>Virtual Reality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504773
org study id: IRB00210075
nct id: NCT04504773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anxiety is a common and impairing problem for children. The principle treatment for pediatric
      anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise
      called exposures. While exposures are effective, some feared situations cannot be confronted
      in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical
      challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to
      rely on imagined exposures, and/or (3) requires families to complete exposures outside of the
      therapy visits. This creates a burden for clinicians and families, and impedes treatment
      success. Immersive virtual reality (VR) presents an innovative solution that allows children
      to face fears without leaving the clinician's office. While VR has been used to distract
      children during painful medical procedures, it has not been well examined as a primary
      treatment for pediatric anxiety. This study proposes to examine the effectiveness and
      acceptability of using immersive VR exposures to treat children and adolescents with specific
      phobias.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Outcomes assessor is not involved in treatment, and will assess the severity of the participants anxiety.
measure: Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)
time frame: 1 week after virtual reality exposure therapy session
description: The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder.
measure: Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)
time frame: 1 week after virtual reality exposure therapy session
description: Parent-reported rating of child anxiety that consists of 41-items. Items are rated on a 3-point scale that ranges from 0 (Not True) to 2 (Very True). The total score ranges from 0 to 82, with a total score of 25 or greater may indicate the presence of an anxiety disorder.
arm group label: Virtual Reality Exposure Therapy
arm group type: Experimental
description: Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures.
intervention type: Behavioral
intervention name: Virtual Reality Exposure Therapy
description: Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
arm group label: Virtual Reality Exposure Therapy
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Joseph F. McGuire, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Phobic Disorders
sharing ipd: No