title: Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00052078.
authors.affiliation: Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, DUMC Box 3527, Durham, NC 27710, USA.
authors.forename: Scott N
authors.initials: SN
authors.lastname: Compton
authors.affiliation: The Johns Hopkins Hospital, Division of Child and Adolescent Psychiatry, 600 North Wolfe Street, Baltimore, MD 21287, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Walkup
authors.affiliation: New York State Psychiatric Institute-Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Albano
authors.affiliation: University of California at Los Angeles, Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, 68-251B, Los Angeles, CA 90095, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Piacentini
authors.affiliation: Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.
authors.forename: Boris
authors.initials: B
authors.lastname: Birmaher
authors.affiliation: Division of Services and Intervention Research, National Institute of Mental Health, 6001 Executive Boulevard, MSC 9633, Bethesda, MD 20892, USA.
authors.forename: Joel T
authors.initials: JT
authors.lastname: Sherrill
authors.affiliation: The Johns Hopkins Hospital, Division of Child and Adolescent Psychiatry, 600 North Wolfe Street, Baltimore, MD 21287, USA.
authors.forename: Golda S
authors.initials: GS
authors.lastname: Ginsburg
authors.affiliation: New York State Psychiatric Institute-Columbia University Medical Center, 1051 Riverside Drive, New York, NY 10032, USA.
authors.forename: Moira A
authors.initials: MA
authors.lastname: Rynn
authors.affiliation: University of California at Los Angeles, Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, 68-251B, Los Angeles, CA 90095, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.affiliation: Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199, USA.
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Waslick
authors.affiliation: Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, 3811 O'Hara Street, Pittsburgh, PA 15213, USA.
authors.forename: Satish
authors.initials: S
authors.lastname: Iyengar
authors.affiliation: Temple University, Department of Psychology, Weiss Hall 1701 North 13th Street, Philadelphia, PA 19122, USA.
authors.forename: Phillip C
authors.initials: PC
authors.lastname: Kendall
authors.affiliation: Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, DUMC Box 3527, Durham, NC 27710, USA.
authors.forename: John S
authors.initials: JS
authors.lastname: March