Clinical trial NCT00052078: Child and Adolescent Anxiety Disorders (CAMS)
Official title: Child/Adolescent Anxiety Multimodal Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Social Phobia
Generalized Anxiety Disorder
Keywords: Phobic Disorders
Anxiety, Separation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-23
Enrollment: 488
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Detailed description: Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.

During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria:

* Major neurological disorder or medical illness that would interfere with participation in the study

Primary outcomes:
measure: Clinical Global Impression - Improvement Scale
timeFrame: Measured at Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: NYSPI/Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh/WPIC
state: Pennsylvania
Study officials:
References:
citation: Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
citation: Piacentini J, Bennett S, Compton SN, Kendall PC, Birmaher B, Albano AM, March J, Sherrill J, Sakolsky D, Ginsburg G, Rynn M, Bergman RL, Gosch E, Waslick B, Iyengar S, McCracken J, Walkup J. 24- and 36-week outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS). J Am Acad Child Adolesc Psychiatry. 2014 Mar;53(3):297-310. doi: 10.1016/j.jaac.2013.11.010. Epub 2013 Nov 28.
citation: Ginsburg GS, Kendall PC, Sakolsky D, Compton SN, Piacentini J, Albano AM, Walkup JT, Sherrill J, Coffey KA, Rynn MA, Keeton CP, McCracken JT, Bergman L, Iyengar S, Birmaher B, March J. Remission after acute treatment in children and adolescents with anxiety disorders: findings from the CAMS. J Consult Clin Psychol. 2011 Dec;79(6):806-13. doi: 10.1037/a0025933.
citation: Compton SN, Walkup JT, Albano AM, Piacentini JC, Birmaher B, Sherrill JT, Ginsburg GS, Rynn MA, McCracken JT, Waslick BD, Iyengar S, Kendall PC, March JS. Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2010 Jan 5;4:1. doi: 10.1186/1753-2000-4-1.
citation: Compton SN, Peris TS, Almirall D, Birmaher B, Sherrill J, Kendall PC, March JS, Gosch EA, Ginsburg GS, Rynn MA, Piacentini JC, McCracken JT, Keeton CP, Suveg CM, Aschenbrand SG, Sakolsky D, Iyengar S, Walkup JT, Albano AM. Predictors and moderators of treatment response in childhood anxiety disorders: results from the CAMS trial. J Consult Clin Psychol. 2014 Apr;82(2):212-24. doi: 10.1037/a0035458. Epub 2014 Jan 13.
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citation: Crane ME, Norris LA, Frank HE, Klugman J, Ginsburg GS, Keeton C, Albano AM, Piacentini J, Peris TS, Compton SN, Sakolsky D, Birmaher B, Kendall PC. Impact of treatment improvement on long-term anxiety: Results from CAMS and CAMELS. J Consult Clin Psychol. 2021 Feb;89(2):126-133. doi: 10.1037/ccp0000523.
citation: Cervin M, Storch EA, Piacentini J, Birmaher B, Compton SN, Albano AM, Gosch E, Walkup JT, Kendall PC. Symptom-specific effects of cognitive-behavioral therapy, sertraline, and their combination in a large randomized controlled trial of pediatric anxiety disorders. J Child Psychol Psychiatry. 2020 Apr;61(4):492-502. doi: 10.1111/jcpp.13124. Epub 2019 Aug 30.
citation: Ginsburg GS, Becker-Haimes EM, Keeton C, Kendall PC, Iyengar S, Sakolsky D, Albano AM, Peris T, Compton SN, Piacentini J. Results From the Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS): Primary Anxiety Outcomes. J Am Acad Child Adolesc Psychiatry. 2018 Jul;57(7):471-480. doi: 10.1016/j.jaac.2018.03.017. Epub 2018 May 9.
citation: Kiff CJ, Ernestus S, Gonzalez A, Kendall PC, Albano AM, Compton SN, Birmaher B, Ginsburg GS, Rynn M, Walkup JT, McCracken J, Piacentini J. The Interplay of Familial and Individual Risk in Predicting Clinical Improvements in Pediatric Anxiety Disorders. J Clin Child Adolesc Psychol. 2018;47(sup1):S542-S554. doi: 10.1080/15374416.2018.1460848. Epub 2018 Jun 7.
citation: Albano AM, Comer JS, Compton SN, Piacentini J, Kendall PC, Birmaher B, Walkup JT, Ginsburg GS, Rynn MA, McCracken J, Keeton C, Sakolsky DJ, Sherrill JT. Secondary Outcomes From the Child/Adolescent Anxiety Multimodal Study: Implications for Clinical Practice. Evid Based Pract Child Adolesc Ment Health. 2018;3(1):30-41. doi: 10.1080/23794925.2017.1399485. Epub 2017 Dec 5.
citation: Taylor JH, Lebowitz ER, Jakubovski E, Coughlin CG, Silverman WK, Bloch MH. Monotherapy Insufficient in Severe Anxiety? Predictors and Moderators in the Child/Adolescent Anxiety Multimodal Study. J Clin Child Adolesc Psychol. 2018 Mar-Apr;47(2):266-281. doi: 10.1080/15374416.2017.1371028. Epub 2017 Sep 28.
citation: Caporino NE, Sakolsky D, Brodman DM, McGuire JF, Piacentini J, Peris TS, Ginsburg GS, Walkup JT, Iyengar S, Kendall PC, Birmaher B. Establishing Clinical Cutoffs for Response and Remission on the Screen for Child Anxiety Related Emotional Disorders (SCARED). J Am Acad Child Adolesc Psychiatry. 2017 Aug;56(8):696-702. doi: 10.1016/j.jaac.2017.05.018. Epub 2017 Jun 6.
citation: Rynn MA, Walkup JT, Compton SN, Sakolsky DJ, Sherrill JT, Shen S, Kendall PC, McCracken J, Albano AM, Piacentini J, Riddle MA, Keeton C, Waslick B, Chrisman A, Iyengar S, March JS, Birmaher B. Child/Adolescent anxiety multimodal study: evaluating safety. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):180-90. doi: 10.1016/j.jaac.2014.12.015. Epub 2014 Dec 31.
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citation: Ginsburg GS, Becker EM, Keeton CP, Sakolsky D, Piacentini J, Albano AM, Compton SN, Iyengar S, Sullivan K, Caporino N, Peris T, Birmaher B, Rynn M, March J, Kendall PC. Naturalistic follow-up of youths treated for pediatric anxiety disorders. JAMA Psychiatry. 2014 Mar;71(3):310-8. doi: 10.1001/jamapsychiatry.2013.4186.
citation: Crawley SA, Caporino NE, Birmaher B, Ginsburg G, Piacentini J, Albano AM, Sherrill J, Sakolsky D, Compton SN, Rynn M, McCracken J, Gosch E, Keeton C, March J, Walkup JT, Kendall PC. Somatic complaints in anxious youth. Child Psychiatry Hum Dev. 2014 Aug;45(4):398-407. doi: 10.1007/s10578-013-0410-x.