Attention and Social Behavior in Children (BRAINS)

January 11, 2018 updated by: Koraly E. Perez-Edgar, Penn State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16801
        • Penn State University Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 9-12 year olds who do not meet exclusionary criteria (split into groups based on high and low temperamental shyness)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABM
Attention bias modification
Behavioral: Attention Bias Modification
This is a modification of the dot-probe task (placebo task) designed to train attention away from threat
Placebo Comparator: Placebo
Dot-probe task
Behavioral: Dot-probe task
This is the active control placebo condition that simply measures levels of attention to threat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Symptoms
Time Frame: 8 weeks
parent and child report of child's anxiety symptoms
8 weeks
Attention bias levels
Time Frame: 8 weeks
performance on computerized attention task
8 weeks
Electrophysiological and neural correlates of attention bias
Time Frame: 8 weeks
EEG and fMRI measures
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 17, 2016

Study Completion (Actual)

December 17, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 5R01MH094633-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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