NCT01979263

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

3.3 years

First QC Date

September 30, 2013

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Variation in genes associated with treatment response

    week 1

Study Arms (2)

Attention Bias Modification

ACTIVE COMPARATOR

Attention Bias Modification computer task

Other: Attention Bias Modification Computer Task

Placebo Computer Task

PLACEBO COMPARATOR

Placebo computer task

Other: Placebo Computer Task

Interventions

Computer task aimed at actively modifying attention bias

Attention Bias Modification

Computer task that does not actively modify attention bias

Placebo Computer Task

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Payne Whitney Manhattan Child Division

New York, New York, 10065, United States

Location

New York Presbyterian Hospital--Westchester Division

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety, SeparationPhobia, SocialPhobia, SpecificObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental DisordersPhobic Disorders

Study Officials

  • Megan H Feltenberger, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

January 17, 2017

Study Completion

January 17, 2017

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations