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Interpretive Biases in Children With Social Anxiety

Primary Purpose

Social Anxiety, Social Anxiety Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Interpretation Training Condition 1
Online Interpretation Training Condition 2
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety focused on measuring Social Anxiety Disorder, Cognitive Training, Interpretation Modification Program

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between ages 8-12
  • Diagnosis of social anxiety disorder
  • Overall IQ score of 80 or greater
  • Speak English fluently as the primary language
  • Working internet connection with access to Skype or Facetime video conferencing software

Exclusion Criteria:

  • Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder or Conduct Disorder
  • Pervasive developmental disorder or autism-spectrum disorder
  • Past or active psychosis, bipolar disorder, or schizophrenia
  • Current evidence-based cognitive-behavioral treatment for social anxiety problems
  • Past cognitive behavioral treatment for social anxiety problems that lasted at least 3 sessions
  • Significant suicidal ideation and/or attempts within the past 3 months
  • Any recent (within the past 4 weeks) or planned changes in medication
  • Reading disorder or impairments in reading ability.

Sites / Locations

  • UWM Anxiety Disorders Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Waitlist Control

Active Interpretation Training

Placebo Interpretation Training

Arm 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

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.

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.

Outcomes

Primary Outcome Measures

Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
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.

Secondary Outcome Measures

Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
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.

Full Information

First Posted
August 14, 2014
Last Updated
October 24, 2016
Sponsor
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT02219243
Brief Title
Interpretive Biases in Children With Social Anxiety
Official Title
Modification of Interpretive Biases in Children With Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Social Anxiety Disorder
Keywords
Social Anxiety Disorder, Cognitive Training, Interpretation Modification Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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 Title
Active Interpretation Training
Arm Type
Experimental
Arm 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 Title
Placebo Interpretation Training
Arm Type
Experimental
Arm 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(s)
Online Interpretation Training Condition 1
Intervention Description
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
Intervention Type
Behavioral
Intervention Name(s)
Online Interpretation Training Condition 2
Intervention Description
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
Primary Outcome Measure Information:
Title
Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
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.
Time Frame
Baseline, 4-weeks, and 1-month follow-up
Secondary Outcome Measure Information:
Title
Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
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.
Time Frame
Baseline, 4 weeks, and 1-month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between ages 8-12 Diagnosis of social anxiety disorder Overall IQ score of 80 or greater Speak English fluently as the primary language Working internet connection with access to Skype or Facetime video conferencing software Exclusion Criteria: Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder or Conduct Disorder Pervasive developmental disorder or autism-spectrum disorder Past or active psychosis, bipolar disorder, or schizophrenia Current evidence-based cognitive-behavioral treatment for social anxiety problems Past cognitive behavioral treatment for social anxiety problems that lasted at least 3 sessions Significant suicidal ideation and/or attempts within the past 3 months Any recent (within the past 4 weeks) or planned changes in medication Reading disorder or impairments in reading ability.
Facility Information:
Facility Name
UWM Anxiety Disorders Laboratory
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

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Interpretive Biases in Children With Social Anxiety

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