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OpenTrials
Completed

NCT Number: NCT00104195

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

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University's Child Study Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intolerance of Uncertainty

    Time frame: at time of assessment/enrollment

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2005
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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