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

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.

The Cochrane Library and the treatment of childhood and adolescent anxiety disorders: an overview of reviews

“…children with cognitive limitations, with certain co-morbidities, or in certain age groups), and examining effectiveness in community samples are a priority (28,38,39,41,42).…”

“…This program was recently adapted for the CAMS (Child/Adolescent Anxiety Multimodal Study), a large-scale examination of combined pharmacological and psychotherapy treatments for three childhood and adolescent anxiety disorders (SAD, GAD, social phobia) (38). 'Coping Cat' emphasizes cognitive restructuring (replacing anxious thoughts with more adaptive thoughts) together with exposure to feared situations and relaxation exercises (36).…”

Anxiety disorders in fragile X premutation carriers: Preliminary characterization of probands and non-probands

“…The remainder of premutation carriers (42.9%) was identified by cascade DNA testing populations (40)(41)(42)(43)(44). It has also been used in validation studies (45)(46)(47)(48) and a federally-funded pediatric anxiety treatment trial (49). Finally, our group has validated the use of the ADIS in a population of children, adolescents and young adults with FXS, with and without ID (16).…”

Threat perception predicts cognitive behavioral therapy outcomes in anxious children

“…Evidence-based treatments include cognitive behavioral therapy (CBT) and serotonin-specific medications. Recent evidence suggests that their combination may be more effective than either alone [3,4]. Nevertheless, substantial numbers of affected children fail to respond, or suffer adverse effects from medication [4,5].…”