Clinical trial NCT02219243: Interpretive Biases in Children With Social Anxiety
Official title: Modification of Interpretive Biases in Children With Social Anxiety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Social Anxiety
Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Cognitive Training
Interpretation Modification Program
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on the Liebowitz Social Anxiety Scale for Children and Adolescents
timeFrame: Baseline, 4-weeks, and 1-month follow-up
Secondary outcomes:
measure: Change on the Multidimensional Anxiety Scale for Children-2nd edition Parent and Self Report
timeFrame: Baseline, 4 weeks, and 1-month Follow-up
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: UWM Anxiety Disorders Laboratory
state: Wisconsin
Study officials:
References: