Attention Bias Modification Treatment for Anxious Youth (ABMT)

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.

Study Overview

• Status: Terminated
• Conditions: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Specific Phobia
• Intervention / Treatment: Other: Attention Bias Modification Computer Task; Other: Placebo Computer Task

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: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Payne Whitney Manhattan Child Division
    • White Plains, New York, United States, 10605
      • New York Presbyterian Hospital--Westchester Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attention Bias Modification; Attention Bias Modification computer task	Other: Attention Bias Modification Computer Task; Computer task aimed at actively modifying attention bias
Placebo Comparator: Placebo Computer Task; Placebo computer task	Other: Placebo Computer Task; 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	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Megan H Feltenberger, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 17, 2017
• Study Completion (Actual): January 17, 2017

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Phobia, Social; Phobic Disorders; Anxiety, Separation
• Other Study ID Numbers: 1207012686R001-IRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes