Clinical trial NCT01979263: Attention Bias Modification Treatment for Anxious Youth
Official title: Attention Bias Modification Treatment for Anxious Youth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
Specific Phobia
Obsessive-Compulsive Disorder
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 5
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
timeFrame: after a 6-week intervention and 4-week no-treatment follow-up
Secondary outcomes:
measure: Variation in genes associated with treatment response
timeFrame: week 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Payne Whitney Manhattan Child Division
state: New York
city: White Plains
country: United States
facility: New York Presbyterian Hospital--Westchester Division
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Megan H Feltenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: