Year: 2010
Type: article
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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00052078.
Institutions: Duke Medical Center, Johns Hopkins University, Johns Hopkins Hospital, Columbia University Irving Medical Center, New York State Psychiatric Institute, University of California, Los Angeles, University of Pittsburgh Medical Center, National Institute of Mental Health, Baystate Medical Center, Temple University
Language: English
Subfield: Experimental and Cognitive Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $3,190
Awards: G2907113034, Child/Adolescent Anxiety Multimodal Treatment Study, Child and Adolescent Anxiety Multisite Study (CAMS), G4038582249, G4142221842, G4638644515, Child/Adolescent Anxiety Multimodal Treatment Study, G525827164, Child/Adolescent Anxiety Multimodal Treatment Study (CAMS), G7996526721, Child/Adolescent Anxiety Multimodal Treatment Study, Child/Adolescent Anxiety Multimodal Treatment Study, Statistics and Methodology in Clinical Trials, G955994181
OpenAlex ID: W2141888160