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

NCT ID: NCT00104195

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Disorders Separation Anxiety Disorder Phobic Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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F. Xavier Castellanos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York University's Child Study Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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H11610

Identifier Type: -

Identifier Source: org_study_id

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