Attention Bias Modification Treatment for Anxious Youth

Study Overview
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Brief Summary
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The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth.

Detailed Description
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The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game. This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder. Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria. If a child is eligible for the study, he or she will be randomly assigned to either get an active form of the computer program or a placebo or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.

Official Title
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Attention Bias Modification Treatment for Anxious Youth

Conditions
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Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder

Intervention / Treatment
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* Other: Attention Bias Modification Computer Task
* Other: Placebo Computer Task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder Age 7 to 17 Exclusion Criteria: Posttraumatic stress disorder or primary diagnosis of major depressive disorder Seizure disorder Current treatment with psychotropic medication Multiple chronic learning disabilities and/or conduct problems

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attention Bias Modification<br>Attention Bias Modification computer task | Other: Attention Bias Modification Computer Task<br>* Computer task aimed at actively modifying attention bias<br>|
| Placebo Comparator: Placebo Computer Task<br>Placebo computer task | Other: Placebo Computer Task<br>* Computer task that does not actively modify attention bias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version |  | after a 6-week intervention and 4-week no-treatment follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in genes associated with treatment response | We will study allelic variation in a gene that has been associated with treatment response to anxiety interventions, the serotonin-transporter-linked promoter region (5-HTTLPR) | week 1 |