Child/Adolescent Anxiety Multimodal Study (CAMS): Rationale, design, and methods

被引：133

作者：

Compton S.N. ^{[1
]}

Walkup J.T. ^{[2
]}

Albano A.M. ^{[3
]}

Piacentini J.C. ^{[4
]}

Birmaher B. ^{[5
]}

Sherrill J.T. ^{[6
]}

Ginsburg G.S. ^{[2
]}

Rynn M.A. ^{[3
]}

McCracken J.T. ^{[4
]}

Waslick B.D. ^{[7
]}

Iyengar S. ^{[5
]}

Kendall P.C. ^{[8
]}

March J.S. ^{[1
]}

机构：

[1] Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, Durham, NC 27710

[2] The Johns Hopkins Hospital, Division of Child and Adolescent Psychiatry, Baltimore, MD 21287

[3] New York State Psychiatric Institute, Columbia University Medical Center, New York, NY 10032

[4] University of California at Los Angeles, Semel Institute for Neuroscience and Human Behavior, 68-251B, Los Angeles, CA 90095

[5] Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA 15213

[6] Division of Services and Intervention Research, National Institute of Mental Health, MSC 9633, Bethesda, MD 20892

[7] Baystate Medical Center, Springfield, MA 01199

[8] Temple University, Department of Psychology, Philadelphia, PA 19122

来源：

Child and Adolescent Psychiatry and Mental Health | / 4卷 / 1期

关键词：

Anxiety Disorder; Generalize Anxiety Disorder; Separation Anxiety Disorder; Anxious Youth; Treatment Visit;

D O I：

10.1186/1753-2000-4-1

中图分类号：

学科分类号：

摘要：

Objective: To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents.Methods: Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described.Results: CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance.Conclusions: CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders.Trial registration: ClinicalTrials.gov NCT00052078. © 2010 Compton et al; licensee BioMed Central Ltd.

引用

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