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Interpretive Biases in Children With Social Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219243
Recruitment Status : Terminated
First Posted : August 18, 2014
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Han Joo Lee, University of Wisconsin, Milwaukee

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Social Anxiety Disorder Behavioral: Online Interpretation Training Condition 1 Behavioral: Online Interpretation Training Condition 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modification of Interpretive Biases in Children With Social Anxiety
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
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.
Behavioral: Online Interpretation Training Condition 1
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.

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.
Behavioral: Online Interpretation Training Condition 2
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.




Primary Outcome Measures :
  1. Change on the Liebowitz Social Anxiety Scale for Children and Adolescents [ Time Frame: Baseline, 4-weeks, and 1-month follow-up ]
    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 :
  1. Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report [ Time Frame: Baseline, 4 weeks, and 1-month Follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219243


Locations
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United States, Wisconsin
UWM Anxiety Disorders Laboratory
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
University of Wisconsin, Milwaukee
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Responsible Party: Han Joo Lee, Assistant Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT02219243    
Other Study ID Numbers: UWM14.141
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Han Joo Lee, University of Wisconsin, Milwaukee:
Social Anxiety Disorder
Cognitive Training
Interpretation Modification Program
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders