CompletedNot Applicable

A Pilot Study of Fear Extinction Learning in Anxious Youth

9 participantsStarted 2014-02

Plain-language summary

The goal of this proposed study is to identify a potential biobehavioral marker of CBT outcome in the most common child and adolescent anxiety disorders, including separation anxiety disorder (SAD), social phobia (SoP), and generalized anxiety disorder (GAD), and to replicate in a clinical sample the previous finding from animal and non-clinical human samples that a difference exists in extinction learning across development.

Who can participate

Age range

7 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 7-25 years inclusively (i.e., must be at least 7 years) at the point of consent * Primary DSM 5 diagnosis of SepAD, SocAD, OCD, specific phobia, or panic disorder on the ADIS-IV-C/P * Anxiety severity of moderate or greater (CGI-S \>3 and functional impairment (CGAS score 60) Exclusion Criteria: * Estimated child Full Scale IQ \< 80, as measured by the vocabulary and block design subtests of the WISC-III) (Gate B). If a potential subject has a verified IQ score in the three years prior to enrollment as measured by the WISC-III, IIIR, K-ABC, or Stanford-Binet no IQ assessment is required. * Child meets criteria for current primary or co-primary major depressive disorder, conduct disorder or substance abuse * Child meets criteria for Major Depressive Disorder at greater severity than anxiety disorder (Gate B) * Subjects with the following lifetime psychiatric disorders will be excluded: bipolar disorder, PDD (Asperger's, autism), MDD with psychosis, schizophrenia, and schizoaffective disorder * Current use of psychotropic medication or clinical indication for use of psychotropic medication (except for youth entering on a stable psychostimulant regimen for ADHD) * Recent treatment with psychotropic medication within 6 weeks of study entry for fluoxetine, within 2 weeks for other SSRIs, and within 4 weeks for neuroleptics (Gates A, B). * Child has failed an adequate trial of CBT for anxiety within the previous 2 years (at least 10 treatment sessions …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ADIS Evaluation

Timeframe: 1 year

Trial details

NCT IDNCT03032926

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Anxiety Disorder of Childhood trials