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Clinical Trials/NCT01979263
NCT01979263TerminatedNot Applicable

Attention Bias Modification Treatment for Anxious Youth

Weill Medical College of Cornell University3 sites in 1 country5 target enrollmentStarted: October 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
3
Primary Endpoint
Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Attention Bias Modification

Active Comparator

Attention Bias Modification computer task

Intervention: Attention Bias Modification Computer Task (Other)

Placebo Computer Task

Placebo Comparator

Placebo computer task

Intervention: Placebo Computer Task (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Variation in genes associated with treatment response(week 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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