Technology and Early Anxiety Treatment

NCT03255122 | Completed

• 1 other identifier: IRB-16-0182
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)

  CGI-S/I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by IEs in the present study. The CGI-S score rates illness severity on a 7-point scale, ranging from 1 ("normal") to 7 ("among the most severely ill patients"). The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").

  5 minutes

Secondary Outcomes (10)

• Children's Global Assessment Scale

  5 minutes

• Child Anxiety Impact Scale

  5 minutes

• Family Burden Assessment Scale

  5 minutes

• Family Accommodation Checklist and Interference Scale

  10 minutes

• Family Accommodation Scale- Anxiety

  10 minutes

Study Arms (2)

Immediate treatment

EXPERIMENTAL

Individuals in this condition will immediately receive I-CALM treatment, which draws on videoconferencing to remotely deliver real time cognitive-behavioral therapy for early child anxiety to families in their home.

Behavioral: I-CALM

Waitlist

OTHER

Individuals in Waitlist will participate in an initial waitlist condition, and then after post-waitlist assessment will be offered the I-CALM intervention. Accordingly families in this condition receive Delayed I-CALM.

Behavioral: Delayed I-CALM

Interventions

I-CALM BEHAVIORAL

Families receiving I-CALM will immediately receive a videoconferencing-based, Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program; Puliafico, Comer, \& Albano, 2013) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior.

Immediate treatment

Delayed I-CALM BEHAVIORAL

Families receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program.

Waitlist

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 3-8 years old, and at least one primary caregiver
• Child has diagnosis of social anxiety disorder (as assessed in pre-treatment assessment).
• Child and parent both speak either English or Spanish fluently
• Family's home is equipped with computing device and high-speed internet

You may not qualify if:

• Child has emotional/behavioral problem more impairing than difficulties captured by an anxiety disorder diagnosis.
• Child receiving medication or other psychotherapy to manage emotional difficulties
• History of severe physical or mental impairments (e.g., intellectual disability, deafness, blindness, pervasive developmental disorder) in child or participating caregiver(s)
• Child is a ward of the state

Sponsors & Collaborators

• Florida International University: lead
• Andrew Kukes Foundation for Social Anxiety: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (23)

• Carpenter AL, Puliafico AC, Kurtz SM, Pincus DB, Comer JS. Extending parent-child interaction therapy for early childhood internalizing problems: new advances for an overlooked population. Clin Child Fam Psychol Rev. 2014 Dec;17(4):340-56. doi: 10.1007/s10567-014-0172-4.

  PMID: 25212716 BACKGROUND

• Comer, J.S. (2015). Introduction to the special section: Applying new technologies to extend the scope and accessibility of mental health care. Cognitive and Behavioral Practice, 22, 253-257. doi:http://dx.doi.org/10.1016/j.cbpra.2015.04.002

  BACKGROUND

• Comer JS, Barlow DH. The occasional case against broad dissemination and implementation: retaining a role for specialty care in the delivery of psychological treatments. Am Psychol. 2014 Jan;69(1):1-18. doi: 10.1037/a0033582. Epub 2013 Aug 5.

  PMID: 23915401 BACKGROUND

• Comer JS, Blanco C, Hasin DS, Liu SM, Grant BF, Turner JB, Olfson M. Health-related quality of life across the anxiety disorders: results from the national epidemiologic survey on alcohol and related conditions (NESARC). J Clin Psychiatry. 2011 Jan;72(1):43-50. doi: 10.4088/JCP.09m05094blu. Epub 2010 Aug 24.

  PMID: 20816036 BACKGROUND

• Comer JS, Furr JM, Cooper-Vince CE, Kerns CE, Chan PT, Edson AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: a preliminary case series. J Clin Child Adolesc Psychol. 2014;43(1):74-87. doi: 10.1080/15374416.2013.855127. Epub 2013 Dec 2.

  PMID: 24295036 BACKGROUND

• Comer JS, Furr JM, Cooper-Vince C, Madigan RJ, Chow C, Chan P, Idrobo F, Chase RM, McNeil CB, Eyberg SM. Rationale and Considerations for the Internet-Based Delivery of Parent-Child Interaction Therapy. Cogn Behav Pract. 2015 Aug 1;22(3):302-316. doi: 10.1016/j.cbpra.2014.07.003.

  PMID: 26120268 BACKGROUND

• Comer JS, Furr JM, Kerns CE, Miguel E, Coxe S, Elkins RM, Carpenter AL, Cornacchio D, Cooper-Vince CE, DeSerisy M, Chou T, Sanchez AL, Khanna M, Franklin ME, Garcia AM, Freeman JB. Internet-delivered, family-based treatment for early-onset OCD: A pilot randomized trial. J Consult Clin Psychol. 2017 Feb;85(2):178-186. doi: 10.1037/ccp0000155. Epub 2016 Nov 21.

  PMID: 27869451 BACKGROUND

• Comer JS, Furr JM, Miguel EM, Cooper-Vince CE, Carpenter AL, Elkins RM, Kerns CE, Cornacchio D, Chou T, Coxe S, DeSerisy M, Sanchez AL, Golik A, Martin J, Myers KM, Chase R. Remotely delivering real-time parent training to the home: An initial randomized trial of Internet-delivered parent-child interaction therapy (I-PCIT). J Consult Clin Psychol. 2017 Sep;85(9):909-917. doi: 10.1037/ccp0000230. Epub 2017 Jun 26.

  PMID: 28650194 BACKGROUND

• Comer JS, Puliafico AC, Aschenbrand SG, McKnight K, Robin JA, Goldfine ME, Albano AM. A pilot feasibility evaluation of the CALM Program for anxiety disorders in early childhood. J Anxiety Disord. 2012 Jan;26(1):40-9. doi: 10.1016/j.janxdis.2011.08.011. Epub 2011 Aug 25.

  PMID: 21917417 BACKGROUND

• Costello EJ, Mustillo S, Erkanli A, Keeler G, Angold A. Prevalence and development of psychiatric disorders in childhood and adolescence. Arch Gen Psychiatry. 2003 Aug;60(8):837-44. doi: 10.1001/archpsyc.60.8.837.

  PMID: 12912767 BACKGROUND

• Egger HL, Angold A. Common emotional and behavioral disorders in preschool children: presentation, nosology, and epidemiology. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):313-37. doi: 10.1111/j.1469-7610.2006.01618.x.

  PMID: 16492262 BACKGROUND

• Guy, W. (1976) ECDEU Assessment Manual for Psychopharmacology - Revised. Rockville, MD: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs.

  BACKGROUND

• Puliafico, A.C., Comer, J.S., & Albano, A.M. (2013). Coaching Approach behavior and Leading by Modeling: Rationale, principles, and a case illustration of the CALM Program for anxious preschoolers. Cognitive and Behavioral Practice, 20, 517-528. doi:http://dx.doi.org/10.1016/j.cbpra.2012.05.002

  BACKGROUND

• Puliafico AC, Comer JS, Pincus DB. Adapting parent-child interaction therapy to treat anxiety disorders in young children. Child Adolesc Psychiatr Clin N Am. 2012 Jul;21(3):607-19. doi: 10.1016/j.chc.2012.05.005. Epub 2012 Jun 2.

  PMID: 22800997 BACKGROUND

• Silverman, W. K., & Albano, A. M. (1997). The Anxiety Disorders Interview Schedule for children for DSM-IV: Child and parent versions. San Antonio, TX: Psychological Corporation.

  BACKGROUND

• Thompson-Hollands J, Kerns CE, Pincus DB, Comer JS. Parental accommodation of child anxiety and related symptoms: range, impact, and correlates. J Anxiety Disord. 2014 Dec;28(8):765-73. doi: 10.1016/j.janxdis.2014.09.007. Epub 2014 Sep 16.

  PMID: 25261837 BACKGROUND

• Keenan K, Wakschlag LS, Danis B. Kiddie-Disruptive Behavior Disorder Schedule. Chicago, IL: U Chicago; 2001.

  BACKGROUND

• Guy W, Bonato RR. Clinical Global Impressions. Chevy Chase, MD: NIMH; 1970.

  BACKGROUND

• Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.

  PMID: 6639293 BACKGROUND

• Achenbach T, Rescorla L. Child Behavior Checklist for Ages 1.5-5. Vermont: ASEBA; 2000.

  BACKGROUND

• Achenbach T. Child Behavior Checklist for Ages 6-18. Vermont: ASEBA; 2001.

  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

• Brestan E, Jacobs J, Rayfield A, Eyberg SM. (1999). A consumer satisfaction measure for parent-child treatments and its relationship to measures of child behavior change. Behav Ther. 1999;30:17-30.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jonathan S Comer, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators masked to each participating family's treatment condition will perform all structured diagnostic interviews and generate responder status data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Families are randomly designed to receive either immediate treatment (I-CALM) or waitlist and then I-CALM

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: August 21, 2017
• Study Start: November 3, 2016
• Primary Completion: January 22, 2020
• Study Completion: April 22, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Locations

US (1)