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

Scott N Compton,Satish Iyengar,Bruce D Waslick,John C Piacentini,Boris Birmaher,John T Walkup,James T Mccracken,Anne Marie Albano,John S March,Joel T Sherrill,Phillip C Kendall,Moira A Rynn,Golda S Ginsburg

doi:10.1186/1753-2000-4-1

Abstract

ObjectiveTo 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.MethodsFollowing 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.ResultsCAMS 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.ConclusionsCAMS 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 registrationClinicalTrials.gov NCT00052078.

Highlights

The purpose of this manuscript is to describe the research design, rationale for the design choices, and methods used to implement the Child/Adolescent Multimodal Study (CAMS), a recently completed federallyfunded, multicenter, randomized comparative treatment trial that examined the short-term efficacy (12-weeks) and long-term durability (36-weeks) of four treatments for childhood and adolescent separation anxiety disorder (SAD), generalized anxiety disorder (GAD), and social phobia (SoP): cognitive-behavioral therapy (CBT), sertraline (SRT), their combination (COMB), and pill placebo (PBO)
Pediatric anxiety disorders are highly comorbid with one another as well as with other psychiatric disorders such as attention-deficit/hyperactivity disorder, major depression, and dysthymia [1,6]
Given their high prevalence and psychiatric comorbidity, anxiety disorders in children and adolescents often results in impairment and distress that significantly interferes with family, academic, and social functioning [1,2,7]

Summary

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 multimeasure, 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

Introduction

Conclusion

31. Klein DF

40. TADS Study Team

49. Brent DA