NCT02401282

Brief Summary

This study examines the way attention may be linked to temperamental risk for anxiety, social behavior and brain processes. The study aims to see if temperamentally at risk youth display an attention bias towards threat, and if anxiety symptoms can be reduced through attentional bias modification training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2016

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

5 years

First QC Date

March 24, 2015

Last Update Submit

January 11, 2018

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

  • Anxiety Symptoms

    parent and child report of child's anxiety symptoms

    8 weeks

  • Attention bias levels

    performance on computerized attention task

    8 weeks

  • Electrophysiological and neural correlates of attention bias

    EEG and fMRI measures

    8 weeks

Study Arms (2)

ABM

EXPERIMENTAL

Attention bias modification

Behavioral: Attention Bias Modification

Placebo

PLACEBO COMPARATOR

Dot-probe task

Behavioral: Dot-probe task

Interventions

Attention Bias ModificationBEHAVIORAL

This is a modification of the dot-probe task (placebo task) designed to train attention away from threat

ABM
Dot-probe taskBEHAVIORAL

This is the active control placebo condition that simply measures levels of attention to threat

Placebo

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • presence or permanent metal orthodontics or implanted metal devices
  • severe psychiatric diagnosis
  • IQ under 70 as assessed by the WISC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University Child Study Center

University Park, Pennsylvania, 16801, United States

Location

Related Publications (7)

  • LoBue V, Perez-Edgar K. Sensitivity to social and non-social threats in temperamentally shy children at-risk for anxiety. Dev Sci. 2014 Mar;17(2):239-47. doi: 10.1111/desc.12110. Epub 2013 Nov 28.

    PMID: 24283271BACKGROUND

  • McDermott JM, Perez-Edgar K, Henderson HA, Chronis-Tuscano A, Pine DS, Fox NA. A history of childhood behavioral inhibition and enhanced response monitoring in adolescence are linked to clinical anxiety. Biol Psychiatry. 2009 Mar 1;65(5):445-8. doi: 10.1016/j.biopsych.2008.10.043. Epub 2008 Dec 24.

    PMID: 19108817BACKGROUND

  • Perez-Edgar K, McDermott JN, Korelitz K, Degnan KA, Curby TW, Pine DS, Fox NA. Patterns of sustained attention in infancy shape the developmental trajectory of social behavior from toddlerhood through adolescence. Dev Psychol. 2010 Nov;46(6):1723-30. doi: 10.1037/a0021064.

    PMID: 20873921BACKGROUND

  • Perez-Edgar K, Reeb-Sutherland BC, McDermott JM, White LK, Henderson HA, Degnan KA, Hane AA, Pine DS, Fox NA. Attention biases to threat link behavioral inhibition to social withdrawal over time in very young children. J Abnorm Child Psychol. 2011 Aug;39(6):885-95. doi: 10.1007/s10802-011-9495-5.

    PMID: 21318555BACKGROUND

  • Perez-Edgar K, Roberson-Nay R, Hardin MG, Poeth K, Guyer AE, Nelson EE, McClure EB, Henderson HA, Fox NA, Pine DS, Ernst M. Attention alters neural responses to evocative faces in behaviorally inhibited adolescents. Neuroimage. 2007 May 1;35(4):1538-46. doi: 10.1016/j.neuroimage.2007.02.006. Epub 2007 Feb 15.

    PMID: 17376704BACKGROUND

  • Williams LR, Degnan KA, Perez-Edgar KE, Henderson HA, Rubin KH, Pine DS, Steinberg L, Fox NA. Impact of behavioral inhibition and parenting style on internalizing and externalizing problems from early childhood through adolescence. J Abnorm Child Psychol. 2009 Nov;37(8):1063-75. doi: 10.1007/s10802-009-9331-3.

    PMID: 19521761BACKGROUND

  • Liu P, Taber-Thomas BC, Fu X, Perez-Edgar KE. Biobehavioral Markers of Attention Bias Modification in Temperamental Risk for Anxiety: A Randomized Control Trial. J Am Acad Child Adolesc Psychiatry. 2018 Feb;57(2):103-110. doi: 10.1016/j.jaac.2017.11.016. Epub 2017 Nov 28.

    PMID: 29413142DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

December 1, 2011

Primary Completion

December 17, 2016

Study Completion

December 17, 2016

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

US(1)