A Pilot Study of Fear Extinction Learning in Anxious Youth
Condition: Anxiety Disorder of Childhood
MeSH terms: Anxiety Disorders
Study type: Observational

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.
    

Detailed description: 
      Study Sample and Design: The study will utilize an open treatment pilot trial design.
      Participants will include 10 individuals, ages 11-18, with a primary anxiety disorder
      diagnosis. Participants must not have failed prior trials of CBT. Participants on psychiatric
      medication must be on a stable dose for at least 2 months prior to study participation and
      remain symptomatic to the level identified for study inclusion (ADIS CSR ≥ 4).

      Measures: Independent evaluators will administer a comprehensive assessment at baseline and
      post-treatment. The Anxiety Disorder Interview Schedule for Children for DSM-5 (ADIS-C-5)19
      will measure the primary outcome of change in clinical severity of anxiety disorder symptoms
      across age groups. The Clinical Global Impression Scale (CGI) will assess overall symptom
      severity. The PARS and the MASC will provide secondary, dimensional measures of anxiety. In
      addition, we will measure treatment adherence and parent engagement as important secondary
      variables.

      Fear Conditioning & Extinction Paradigm: Subjects will participate in a laboratory test of
      extinction training prior to CBT in order to establish extinction learning as a potential
      predictive marker of treatment outcome. Subjects will be exposed to two shapes on a computer
      screen, one shape (conditioned stimulus (CS+) will be paired with an aversive sound
      (unconditioned stimulus) on 38% of the trials, whereas the other shape will never be paired
      with aversive sound (CS-)20. A day later, individuals will undergo extinction training in
      which the two conditioned stimuli will be repeatedly presented without the unconditioned
      stimulus. Extinction will be measured as the difference score of skin conductance response to
      the CS+ and CS-.

      Exposure Therapy Intervention: investigators will offer participants an 8 session exposure
      therapy intervention. Session one will consist of psychoeducation and completion of an
      exposure hierarchy. Sessions 2-7 will consist of weekly gradual exposure sessions. Session 8
      will include review, relapse prevention and referral to additional treatment if needed.
      Assessment measures will be given at the completion of each exposure session to assess
      individual differences in symptom change related to exposure therapy. All treatment sessions
      will be videotaped to ensure fidelity to treatment manual and modules.

      Data analysis plan: Investigators will track the monthly number of participants screened and
      enrolled to determine feasibility of a larger trial, as well as session attendance, study
      attrition, treatment adherence and patient safety to assess acceptability of the selected
      measures and interventions. Though this pilot will not be adequately powered to detect
      statistical significance, the investigators will execute a preliminary test of the
      association between performance on the extinction learning task and treatment outcome, and
      the investigators will assess age group differences in extinction learning and treatment
      outcome to determine early proof of concept.
    

Intervention name(s): Open Trial
Intervention type(s): Behavioral
Intervention description(s): Behavioral Intervention
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Youth with anxiety disorders ages 7-25
      
Keywords: Anxiety