This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of the proposed study is to further our knowledge of the treatment of childhood anxiety disorders, specifically separation anxiety disorder (SAD), social phobia (SP) and generalized anxiety disorder (GAD). Several considerations contribute to the importance of evaluating treatments for these disorders. First, as a group, these disorders are exceedingly common, typically co-occur and are associated with serious impairment. Second, not only are the disorders associated with disadvantage during childhood, but also if untreated, a significant proportion of affected children face prolonged impairment extending into adulthood. Third, while recent studies establish the benefits of both CBT and selective serotonin re-uptake inhibitors (SSRIs), there are no studies comparing the efficacy of these treatments and their combination against a control condition in the same clinical population. Studies by members of our group provide evidence for the efficacy of CBT and the selective serotonin reuptake inhibitors (SSRIs). However, methodological differences across trials and the absence of a combination treatment cell limit generalizability to clinical practice. Through established collaborations initially fostered by the NIMH Research Units of Pediatric Psychopharmacology initiative (RUPP), we propose a multi-site randomized controlled trial to replicate and extend the initial findings from the psychopharmacology and CBT literatures, and to address related questions of mediators and moderators of outcome. Seven sites are involved in this trial: Duke University Medical Center; Johns Hopkins Medical Institutions; NYU/NYSPI, Temple University/U Penn; University of California at Los Angeles; and Western Psychiatric Institute and Clinic and the NIMH. The study goals will be addressed through a six-year, multisite, 2-phase study. Phase I is a 12-week randomized controlled efficacy study comparing SRT, CBT, their combination (COMB), with pill placebo (PBO) in 478 children (ages 7-17 years) with primary diagnoses of DSM-IV SAD, SP, and GAD. Phase II involves a 6-month treatment maintenance period for responders to the three active treatments. All subjects regardless of response status will be evaluated at all scheduled assessment points. In addition to parent, child, and clinician report, blind Independent Evaluators (IE) will assess the primary outcome variables. Besides state-of-the art intervention protocols, quality assurance and adverse event monitoring procedures are employed to insure uniform cross-site administration of the protocol.
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