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