A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions

April 15, 2014 updated by: F. Xavier Castellanos, NYU Langone Health

Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth

The purpose of this trial is to study how teens with and without an anxiety disorder make decisions.

This is a brain imaging study using functional magnetic resonance imaging (fMRI) in adolescents between the ages of 13 and 17.

Study Overview

Status

Completed

Conditions

Detailed Description

Preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. However, behavioral ratings of certainty during the task showed differences between groups. Anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p < .05). This difference was consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks showed that subjects responded as expected. Reaction times (RT) during uncertain conditions of the HiLo-Game were significantly longer than during more certain conditions (p = .001). Diary Task RTs for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p < .05). Preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary results were not submitted for publication.

Study Type

Observational

Enrollment (Actual)

127

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
    • New York
      • New York, New York, United States, 10016
        • New York University's 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

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anxious and healthy adolescents

Description

Inclusion Criteria:

  • Must meet diagnostic criteria for Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia, OR must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls)
  • Sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history

Exclusion Criteria:

  • Having any major medical conditions that may interfere with interpretation of results or be associated with risk in an MRI environment (history of metal implants, or contraindications to MRI scanning for research purposes, including pregnancy)
  • Current evidence of Autism, Major Depression, Substance Abuse, Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Panic Disorder, Tic Disorders, significant suicidality, lifetime history of psychosis or mania.
  • Estimated Full-Scale IQ below 80
  • Inability or unwillingness to remain still during scanning
  • Inability or unwillingness to provide assent
  • Absence of signed consent by parent or legal guardian
  • Current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing Department of Social Services (DSS) involvement

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intolerance of Uncertainty
Time Frame: at time of assessment/enrollment
at time of assessment/enrollment

Collaborators and Investigators

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

Sponsor

NYU Langone Health

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

February 1, 2004

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 23, 2005

First Submitted That Met QC Criteria

February 23, 2005

First Posted (Estimate)

February 24, 2005

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11610

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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