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Attention Bias Modification Treatment for Anxious Youth (ABMT)

Primary Purpose

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention Bias Modification Computer Task
Placebo Computer Task
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Payne Whitney Manhattan Child Division
  • New York Presbyterian Hospital--Westchester Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Attention Bias Modification

Placebo Computer Task

Arm Description

Attention Bias Modification computer task

Placebo computer task

Outcomes

Primary Outcome Measures

Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version

Secondary Outcome Measures

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)

Full Information

First Posted
September 30, 2013
Last Updated
July 29, 2019
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01979263
Brief Title
Attention Bias Modification Treatment for Anxious Youth
Acronym
ABMT
Official Title
Attention Bias Modification Treatment for Anxious Youth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment/data collection
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 17, 2017 (Actual)
Study Completion Date
January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification
Arm Type
Active Comparator
Arm Description
Attention Bias Modification computer task
Arm Title
Placebo Computer Task
Arm Type
Placebo Comparator
Arm Description
Placebo computer task
Intervention Type
Other
Intervention Name(s)
Attention Bias Modification Computer Task
Intervention Description
Computer task aimed at actively modifying attention bias
Intervention Type
Other
Intervention Name(s)
Placebo Computer Task
Intervention Description
Computer task that does not actively modify attention bias
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Variation in genes associated with treatment response
Description
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)
Time Frame
week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan H Feltenberger, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Payne Whitney Manhattan Child Division
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New York Presbyterian Hospital--Westchester Division
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Attention Bias Modification Treatment for Anxious Youth

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