<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/NCT02219243</url>
  </required_header>
  <id_info>
    <org_study_id>UWM14.141</org_study_id>
    <nct_id>NCT02219243</nct_id>
  </id_info>
  <brief_title>Interpretive Biases in Children With Social Anxiety</brief_title>
  <official_title>Modification of Interpretive Biases in Children With Social Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Milwaukee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Milwaukee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A substantial number of children with social anxiety fail to gain benefit from contemporary&#xD;
      cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment of&#xD;
      social anxiety are needed. The current study attempts to modify an interpretation style that&#xD;
      is characteristic of children who also display high anxiety in social situations.&#xD;
      Participants between the ages of 8-12 years old, with social anxiety, will be randomly&#xD;
      assigned to one of three treatment conditions: two conditions are designed to manipulate the&#xD;
      interpretation bias or a wait-list control condition. All study procedures will be conducted&#xD;
      online. This study will help develop an effective cognitive intervention program for social&#xD;
      anxiety in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study aims to test the effectiveness of computer-based interpretation bias&#xD;
      modification training as a therapeutic intervention for social anxiety disorder (SAD).&#xD;
      Individuals who experience social anxiety often have difficulty in engaging in social&#xD;
      situations, such as speaking in front of a group and maintaining a conversation. For&#xD;
      youngsters, this may take the form of avoidance, including avoiding situations such as&#xD;
      raising one's hand in class, eating in front of other people and participating in small group&#xD;
      activities. Additionally, those with social anxiety are more likely to interpret ambiguous&#xD;
      social scenarios in a threatening way than are control subjects (Bogels, Snieder, &amp; Kindt,&#xD;
      2003; Miers, Blote, Bogels, &amp; Westenberg, 2008; Vassilopoulos &amp; Banerjee, 2008;&#xD;
      Vassilopoulos, 2006; Muris, Meckelbach, &amp; Damsma, 2000). Research has shown that&#xD;
      interpretation biases are modifiable at a young age (Muris, Huijding, Mayer, &amp; Hameetman,&#xD;
      2008; Vassilopoulous, Bangerjee, Prantzalou, 2009; Muris, Huijding, Mayer, Remmerswaal, &amp;&#xD;
      Vreden, 2009; Lothmann, Holmes, Chan, &amp; Lau, 2010).&#xD;
&#xD;
      Participants between the ages of 8-12 years old, with social anxiety, will be randomly&#xD;
      assigned to one of three treatment conditions: two conditions are designed to manipulate the&#xD;
      interpretation bias or a wait-list control condition. All study procedures will be conducted&#xD;
      online. Subjects do not need to come to the University of Wisconsin-Milwaukee to participate.&#xD;
      Thirty children with social anxiety will be randomly assigned to one of the three conditions,&#xD;
      and will be assessed at baseline, post-treatment, and 1-month follow-up. The waitlisted&#xD;
      participants will also be invited to undergo the training program after the 1-month follow-up&#xD;
      assessment is completed. This study is expected to generate important data that will guide&#xD;
      the development of an accessible, cost-efficient, and effective cognitive intervention for&#xD;
      individuals suffering from social anxiety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on the Liebowitz Social Anxiety Scale for Children and Adolescents</measure>
    <time_frame>Baseline, 4-weeks, and 1-month follow-up</time_frame>
    <description>A clinician-rated measure for assessing the severity of social anxiety and the impairment caused by it. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report</measure>
    <time_frame>Baseline, 4 weeks, and 1-month Follow-up</time_frame>
    <description>This is a widely used assessment tool for symptoms of anxiety disorders. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Social Anxiety</condition>
  <condition>Social Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is a 1-month waitlist control to be compared with the active online interpretation training interventions. This is a no intervention control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Interpretation Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online Interpretation Training Condition 2 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Interpretation Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online Interpretation Training Condition 1 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Interpretation Training Condition 1</intervention_name>
    <description>The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.</description>
    <arm_group_label>Active Interpretation Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Interpretation Training Condition 2</intervention_name>
    <description>The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.</description>
    <arm_group_label>Placebo Interpretation Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ages 8-12&#xD;
&#xD;
          -  Diagnosis of social anxiety disorder&#xD;
&#xD;
          -  Overall IQ score of 80 or greater&#xD;
&#xD;
          -  Speak English fluently as the primary language&#xD;
&#xD;
          -  Working internet connection with access to Skype or Facetime video conferencing&#xD;
             software&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder or Conduct&#xD;
             Disorder&#xD;
&#xD;
          -  Pervasive developmental disorder or autism-spectrum disorder&#xD;
&#xD;
          -  Past or active psychosis, bipolar disorder, or schizophrenia&#xD;
&#xD;
          -  Current evidence-based cognitive-behavioral treatment for social anxiety problems&#xD;
&#xD;
          -  Past cognitive behavioral treatment for social anxiety problems that lasted at least 3&#xD;
             sessions&#xD;
&#xD;
          -  Significant suicidal ideation and/or attempts within the past 3 months&#xD;
&#xD;
          -  Any recent (within the past 4 weeks) or planned changes in medication&#xD;
&#xD;
          -  Reading disorder or impairments in reading ability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UWM Anxiety Disorders Laboratory</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Wisconsin, Milwaukee</investigator_affiliation>
    <investigator_full_name>Han Joo Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Social Anxiety Disorder</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>Interpretation Modification Program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</mesh_term>
  </condition_browse>
  <!-- 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/NCT02219243
org study id: UWM14.141
nct id: NCT02219243
lead sponsor: 
has dmc: No
A substantial number of children with social anxiety fail to gain benefit from contemporary
      cognitive-behavior therapy (CBT) approaches. More novel treatment approaches for treatment of
      social anxiety are needed. The current study attempts to modify an interpretation style that
      is characteristic of children who also display high anxiety in social situations.
      Participants between the ages of 8-12 years old, with social anxiety, will be randomly
      assigned to one of three treatment conditions: two conditions are designed to manipulate the
      interpretation bias or a wait-list control condition. All study procedures will be conducted
      online. This study will help develop an effective cognitive intervention program for social
      anxiety in children.
The current study aims to test the effectiveness of computer-based interpretation bias
      modification training as a therapeutic intervention for social anxiety disorder (SAD).
      Individuals who experience social anxiety often have difficulty in engaging in social
      situations, such as speaking in front of a group and maintaining a conversation. For
      youngsters, this may take the form of avoidance, including avoiding situations such as
      raising one's hand in class, eating in front of other people and participating in small group
      activities. Additionally, those with social anxiety are more likely to interpret ambiguous
      social scenarios in a threatening way than are control subjects (Bogels, Snieder, & Kindt,
      2003; Miers, Blote, Bogels, & Westenberg, 2008; Vassilopoulos & Banerjee, 2008;
      Vassilopoulos, 2006; Muris, Meckelbach, & Damsma, 2000). Research has shown that
      interpretation biases are modifiable at a young age (Muris, Huijding, Mayer, & Hameetman,
      2008; Vassilopoulous, Bangerjee, Prantzalou, 2009; Muris, Huijding, Mayer, Remmerswaal, &
      Vreden, 2009; Lothmann, Holmes, Chan, & Lau, 2010).

      Participants between the ages of 8-12 years old, with social anxiety, will be randomly
      assigned to one of three treatment conditions: two conditions are designed to manipulate the
      interpretation bias or a wait-list control condition. All study procedures will be conducted
      online. Subjects do not need to come to the University of Wisconsin-Milwaukee to participate.
      Thirty children with social anxiety will be randomly assigned to one of the three conditions,
      and will be assessed at baseline, post-treatment, and 1-month follow-up. The waitlisted
      participants will also be invited to undergo the training program after the 1-month follow-up
      assessment is completed. This study is expected to generate important data that will guide
      the development of an accessible, cost-efficient, and effective cognitive intervention for
      individuals suffering from social anxiety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
time frame: Baseline, 4-weeks, and 1-month follow-up
description: A clinician-rated measure for assessing the severity of social anxiety and the impairment caused by it. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.
measure: Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
time frame: Baseline, 4 weeks, and 1-month Follow-up
description: This is a widely used assessment tool for symptoms of anxiety disorders. This measure will be administered at baseline, at 4 weeks, and at 1-month follow-up.
arm group label: Waitlist Control
arm group type: No Intervention
description: This is a 1-month waitlist control to be compared with the active online interpretation training interventions. This is a no intervention control group
arm group label: Active Interpretation Training
arm group type: Experimental
description: Online Interpretation Training Condition 2 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.
arm group label: Placebo Interpretation Training
arm group type: Experimental
description: Online Interpretation Training Condition 1 provides three sessions of a computerized training. Each session will last approximately 20-30 minutes, and participants will undergo 1 session each week.
intervention type: Behavioral
intervention name: Online Interpretation Training Condition 1
description: The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
arm group label: Active Interpretation Training
intervention type: Behavioral
intervention name: Online Interpretation Training Condition 2
description: The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
arm group label: Placebo Interpretation Training
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Wisconsin, Milwaukee
investigator full name: Han Joo Lee
investigator title: Assistant Professor
mesh term: Anxiety Disorders
mesh term: Phobia, Social