Clinical trial NCT00104195: A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions
Official title: Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Separation Anxiety Disorder
Phobic Disorders
Keywords: Anxiety
Adolescence
Generalized Anxiety Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2005-02-24
Enrollment: 127
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anxious and healthy adolescents

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intolerance of Uncertainty
timeFrame: at time of assessment/enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University's Child Study Center
state: New York
Study officials:
References: