- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979263
Attention Bias Modification Treatment for Anxious Youth (ABMT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Payne Whitney Manhattan Child Division
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White Plains, New York, United States, 10605
- New York Presbyterian Hospital--Westchester Division
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Attention Bias Modification
Attention Bias Modification computer task
|
Computer task aimed at actively modifying attention bias
|
Placebo Comparator: Placebo Computer Task
Placebo computer task
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Computer task that does not actively modify attention bias
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
Time Frame: after a 6-week intervention and 4-week no-treatment follow-up
|
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
Time Frame: week 1
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Megan H Feltenberger, PhD, Weill Medical College of Cornell University
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1207012686R001-IRB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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