A Pilot Study of Fear Extinction Learning in Anxious Youth

NCT03032926 | Completed DMC

• 1 other identifier: 1310014441
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anxiety Disorder of Childhood

Keywords

Anxiety

Outcome Measures

Primary Outcomes (1)

• ADIS Evaluation

  Anxiety Disorders Interview Schedule for DSM-5-Adult Version

  1 year

Study Arms (1)

Open Trial

N/A - Open Trial

Behavioral: Open Trial

Interventions

Open Trial BEHAVIORAL

Behavioral Intervention

Open Trial

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Youth with anxiety disorders ages 7-25

You may qualify if:

• 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)

You may not qualify if:

• 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 over a period of less than 1 year conducted by a licensed provider of CBT)
• Child has a major neurological disorder, a major medical illness or hearing impairment that requires a prohibited episodic or chronic systemic medication or that would interfere
• Child is pregnant as indicated by history or a positive pregnancy test at Gate B. Sexually active girls must agree to use an effective form of birth control, either hormonal (BCP, Depo-Provera or Norplant), spermicide (foam or vaginal suppository) or a barrier method (condoms, diaphragm, cervical cap) or a combination of barrier/spermicide contraception in order to participate in the study.
• Child poses a significant risk for dangerousness to self or to others
• Child or parent is non-English speaking (unable to complete measures, IE ratings or treatment without the assistance of a translator) NYSPI and UCLA may recruit Spanish speaking subjects.
• Child is a victim of ongoing or previously undisclosed child abuse requiring new department of social service report or ongoing department of social service supervision
• Child has a history of seizures

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Shannon Bennett, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 26, 2017
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share