Child and Adolescent Anxiety Disorders (CAMS)
Primary Purpose
Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sertraline (SRT)
Cognitive Behavioral Therapy (CBT)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring Phobic Disorders, Anxiety, Separation
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
Sites / Locations
- UCLA
- Johns Hopkins University
- NYSPI/Columbia University
- Duke University
- Temple University
- University of Pittsburgh/WPIC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Sertraline
CBT
SRT + CBT
Placebo
Arm Description
Participants received sertraline for 12 weeks.
Participants received cognitive behavioral therapy for 12 weeks
Participants received both sertraline and CBT for 12 weeks.
Participants received a placebo pill for 12 weeks.
Outcomes
Primary Outcome Measures
Clinical Global Impression - Improvement Scale
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT00052078
First Posted
January 22, 2003
Last Updated
August 21, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00052078
Brief Title
Child and Adolescent Anxiety Disorders (CAMS)
Official Title
Child/Adolescent Anxiety Multimodal Treatment Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Social Phobia, Generalized Anxiety Disorder
Keywords
Phobic Disorders, Anxiety, Separation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sertraline
Arm Type
Active Comparator
Arm Description
Participants received sertraline for 12 weeks.
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
Participants received cognitive behavioral therapy for 12 weeks
Arm Title
SRT + CBT
Arm Type
Active Comparator
Arm Description
Participants received both sertraline and CBT for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a placebo pill for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sertraline (SRT)
Other Intervention Name(s)
Zoloft
Intervention Description
Participants were treated with sertraline.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
Participants received CBT.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants were treated with a placebo pill.
Primary Outcome Measure Information:
Title
Clinical Global Impression - Improvement Scale
Description
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
Time Frame
Measured at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
NYSPI/Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh/WPIC
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
18974308
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. Erratum In: N Engl J Med. 2013 Jan 31;368(5):490.
Results Reference
result
PubMed Identifier
24565357
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.
Results Reference
result
PubMed Identifier
22122292
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.
Results Reference
result
PubMed Identifier
20051130
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.
Results Reference
result
PubMed Identifier
24417601
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.
Results Reference
result
PubMed Identifier
20206470
Citation
Kendall PC, Compton SN, Walkup JT, Birmaher B, Albano AM, Sherrill J, Ginsburg G, Rynn M, McCracken J, Gosch E, Keeton C, Bergman L, Sakolsky D, Suveg C, Iyengar S, March J, Piacentini J. Clinical characteristics of anxiety disordered youth. J Anxiety Disord. 2010 Apr;24(3):360-5. doi: 10.1016/j.janxdis.2010.01.009. Epub 2010 Feb 6.
Results Reference
result
PubMed Identifier
33705168
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.
Results Reference
derived
PubMed Identifier
31471911
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.
Results Reference
derived
PubMed Identifier
29960692
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.
Results Reference
derived
PubMed Identifier
29877727
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.
Results Reference
derived
PubMed Identifier
30906874
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.
Results Reference
derived
PubMed Identifier
28956620
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.
Results Reference
derived
PubMed Identifier
28735699
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.
Results Reference
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PubMed Identifier
25721183
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.
Results Reference
derived
PubMed Identifier
24610431
Citation
Gonzalez A, Peris TS, Vreeland A, Kiff CJ, Kendall PC, Compton SN, Albano AM, Birmaher B, Ginsburg GS, Keeton CP, March J, McCracken J, Rynn M, Sherrill J, Walkup JT, Piacentini J. Parental anxiety as a predictor of medication and CBT response for anxious youth. Child Psychiatry Hum Dev. 2015 Feb;46(1):84-93. doi: 10.1007/s10578-014-0454-6.
Results Reference
derived
PubMed Identifier
24477837
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.
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PubMed Identifier
24129543
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.
Results Reference
derived
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Child and Adolescent Anxiety Disorders (CAMS)
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