- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219243
Interpretive Biases in Children With Social Anxiety
Modification of Interpretive Biases in Children With Social Anxiety
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- UWM Anxiety Disorders Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist Control
This is a 1-month waitlist control to be compared with the active online interpretation training interventions.
This is a no intervention control group
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Experimental: Active Interpretation Training
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.
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The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
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Experimental: Placebo Interpretation Training
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.
|
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
Time Frame: Baseline, 4-weeks, and 1-month follow-up
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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.
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Baseline, 4-weeks, and 1-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
Time Frame: Baseline, 4 weeks, and 1-month Follow-up
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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.
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Baseline, 4 weeks, and 1-month Follow-up
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWM14.141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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