Test of an Inhibitory Learning Model of Extinction in Treatment of Anxious Youth

NCT03372915 | Completed

• 1 other identifier: 17-2040
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, basic research conducted in adults has revealed that fear extinction, or the weakening of a learned fear response, may be best explained by principles of "inhibitory learning." New guidelines for the clinical practice of exposure therapy for anxiety disorders have arisen from research on inhibitory learning, but these guidelines have not yet been empirically tested in youth with anxiety disorders. The overall goal of this research is to investigate the acceptability, feasibility, and efficacy of conducting exposure therapy for anxiety disorders in youth according to clinical guidelines developed from basic research on inhibitory learning principles, using a pilot randomized controlled trial design.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (5)

• Change in Percentage of Exposure Refusals (Feasibility Measure)

  Therapists will record the percentage of exposures the patient refused to complete during the session.

  Treatment weeks 5, 6, 7, and 8

• Change in Latency to Initiating Exposure (Feasibility Measure)

  Therapist will record the average amount of time the patient delayed before initiating each exposure in session

  Treatment weeks 5, 6, 7, 8

• Early Treatment Termination (Feasibility Measure)

  Information will be collected regarding whether the patient terminated treatment early (before session 9)

  Measure will be collected following the patient's termination from treatment

• Change in Homework Completion (Feasibility Measure)

  Therapist will record the number of exposure sessions for which the patient completed homework

  Treatment weeks 6, 7, 8, and 9

• Client Satisfaction Questionnaire-8 (CSQ-8)

  8-item measure of patient satisfaction with treatment. The measure is rated on a four-point scale, with possible scores ranging from 8-32.

  Week 9 (End of Treatment)

Secondary Outcomes (5)

• Change in Distress Tolerance Scale--Child (DTS-C)

  Treatment Week 1, Week 5, and Week 9 (End of Treatment)

• Change in Child Avoidance Measure, Self and Parent Report (CAMS/P)

  Treatment Week 1, Week 5, and Week 9 (End of Treatment)

• Change in Avoidance and Fusion Questionnaire--Youth (AFQ-Y)

  Treatment Week 1, Week 5, and Week 9 (End of Treatment)

• Change in Parent Acceptance and Action Questionnaire (PAAQ)

  Treatment Week 1, Week 5, and Week 9 (End of Treatment)

• Change in Screen for Child Anxiety Related Disorders (SCARED), Self and Parent Report

  Treatment Week 1, Week 5, Week 6, Week 7, Week 8, and Week 9 (End of Treatment)

Study Arms (2)

Standard Exposure

ACTIVE COMPARATOR

This arm will receive exposure therapy conducted according to standard care practices.

Behavioral: Standard Exposure

Exposure + Inhibitory Learning

EXPERIMENTAL

This arm will receive exposure therapy conducted according to principles of inhibitory learning.

Behavioral: Exposure + Inhibitory Learning

Interventions

Standard Exposure BEHAVIORAL

Exposure therapy conducted according to standard clinical care practices

Standard Exposure

Exposure + Inhibitory Learning BEHAVIORAL

Exposure therapy conducted according to practice recommendations based derived from research on inhibitory learning theories of fear extinction

Exposure + Inhibitory Learning

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary or secondary diagnosis of an anxiety disorder
• Ability of both child and caregiver to read and understand English
• Ability of child and at least one caregiver to attend weekly sessions

You may not qualify if:

• Diagnosis of autism spectrum disorder, intellectual development disorder, or limited cognitive functioning (i.e., documented Intelligence Quotient \[IQ\]\<80).
• Diagnosis of a psychotic disorder or bipolar disorder
• Severe and current suicidal ideation, history of suicide attempt in past six months, or frequent and persistent self-injurious behavior
• Diagnosis of a substance use disorder or significant, recent substance use
• Any youth receiving concurrent individual therapy will also be excluded from the study.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (17)

• Arch, J. J., & Abramowitz, J. S. (2015). Exposure therapy for obsessive-compulsive disorder: An optimizing inhibitory learning approach. Journal of Obsessive-Compulsive and Related Disorders, 6, 174-182.

  BACKGROUND

• Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.

  PMID: 9100430 BACKGROUND

• Cheron DM, Ehrenreich JT, Pincus DB. Assessment of parental experiential avoidance in a clinical sample of children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):383-403. doi: 10.1007/s10578-009-0135-z. Epub 2009 Mar 12.

  PMID: 19280337 BACKGROUND

• Craske MG, Kircanski K, Zelikowsky M, Mystkowski J, Chowdhury N, Baker A. Optimizing inhibitory learning during exposure therapy. Behav Res Ther. 2008 Jan;46(1):5-27. doi: 10.1016/j.brat.2007.10.003. Epub 2007 Oct 7.

  PMID: 18005936 BACKGROUND

• Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014 Jul;58:10-23. doi: 10.1016/j.brat.2014.04.006. Epub 2014 May 9.

  PMID: 24864005 BACKGROUND

• Deacon B, Kemp JJ, Dixon LJ, Sy JT, Farrell NR, Zhang AR. Maximizing the efficacy of interoceptive exposure by optimizing inhibitory learning: a randomized controlled trial. Behav Res Ther. 2013 Sep;51(9):588-96. doi: 10.1016/j.brat.2013.06.006. Epub 2013 Jul 6.

  PMID: 23872701 BACKGROUND

• Ehrenreich-May, J., Kennedy, S. M., Sherman, J., Bilek, E. L., Buzzella, B., Bennett, S., & Barlow, D. H. (In press). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents. New York: Oxford University Press.

  BACKGROUND

• Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.

  PMID: 2871574 BACKGROUND

• Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.

  PMID: 18557686 BACKGROUND

• Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2016;45(2):91-113. doi: 10.1080/15374416.2015.1046177. Epub 2015 Jun 18.

  PMID: 26087438 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Milad MR, Pitman RK, Ellis CB, Gold AL, Shin LM, Lasko NB, Zeidan MA, Handwerger K, Orr SP, Rauch SL. Neurobiological basis of failure to recall extinction memory in posttraumatic stress disorder. Biol Psychiatry. 2009 Dec 15;66(12):1075-82. doi: 10.1016/j.biopsych.2009.06.026. Epub 2009 Sep 12.

  PMID: 19748076 BACKGROUND

• Muris, P., Merckelbach, H., van Brakel, A., Mayer, B., & van Dongen, L. (1998). The Screen for Child Anxiety Related Emotional Disorders (SCARED): Relationship with anxiety and depression in normal children. Personality and Individual Differences, 24(4), 451-456.

  BACKGROUND

• Shin LM, Liberzon I. The neurocircuitry of fear, stress, and anxiety disorders. Neuropsychopharmacology. 2010 Jan;35(1):169-91. doi: 10.1038/npp.2009.83.

  PMID: 19625997 BACKGROUND

• Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and Emotion, 29(2), 83-102.

  BACKGROUND

• Whiteside SP, Ale CM, Young B, Dammann JE, Tiede MS, Biggs BK. The feasibility of improving CBT for childhood anxiety disorders through a dismantling study. Behav Res Ther. 2015 Oct;73:83-9. doi: 10.1016/j.brat.2015.07.011. Epub 2015 Jul 29.

  PMID: 26275761 BACKGROUND

• Whiteside SP, Gryczkowski M, Ale CM, Brown-Jacobsen AM, McCarthy DM. Development of child- and parent-report measures of behavioral avoidance related to childhood anxiety disorders. Behav Ther. 2013 Jun;44(2):325-37. doi: 10.1016/j.beth.2013.02.006. Epub 2013 Mar 4.

  PMID: 23611081 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jessica Hawks, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 14, 2017
• Study Start: January 31, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)