Interpretive Biases in Children With Social Anxiety

Social Anxiety Disorder Clinical Trial

Official title:

Modification of Interpretive Biases in Children With Social Anxiety

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02219243
• Other study ID #: UWM14.141
• Status: Terminated
• Phase: N/A
• First received: August 14, 2014
• Last updated: October 24, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety
• Social Anxiety Disorder

Intervention

Behavioral:
• Online Interpretation Training Condition 1
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
• Online Interpretation Training Condition 2
The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.

Locations

Country	Name	City	State
United States	UWM Anxiety Disorders Laboratory	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4-weeks, and 1-month follow-up	No
Secondary	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.	Baseline, 4 weeks, and 1-month Follow-up	No

External Links

•   Child Social Anxiety Study Info