Child/Adolescent Anxiety Multimodal Treatment Study
Project Number1U01MH064088-01A1
Former Number1U10MH064088-01A1
Contact PI/Project LeaderPIACENTINI, JOHN C.
Awardee OrganizationUNIVERSITY OF CALIFORNIA LOS ANGELES
Description
Abstract Text
DESCRIPTION (provided by applicant): With point prevalence estimates ranging
from 12 percent to 20 percent, anxiety disorders are among the most common
conditions affecting children and adolescents. The three most commonly
impairing childhood-onset anxiety disorders are separation anxiety disorder,
social phobia and generalized anxiety disorder. As a group, these disorders
routinely co-occur and cause clinically significant distress and impairment
affecting school, social, and family functioning. Left untreated, these
disorders leave children at risk for anxiety disorders, major depression and,
in some cases, substance abuse extending into late adolescence and adulthood.
Hence, effective treatments for childhood-onset anxiety disorders promise to
alleviate and perhaps to prevent long-term morbidity and even mortality. In
randomized controlled trials, we have shown that two monotherapies,
cognitive-behavioral therapy (CBT) and the selective serotonin reuptake
inhibitor (SSRI), fluvoxamine (FLV), are effective treatments for separation
anxiety, social phobia, and generalized anxiety disorders in children and
adolescents. Even though the monotherapies are effective a substantial number
of patients remain symptomatic following treatment and, might have benefited
from combined treatment. There are as yet no systematic, controlled studies
comparing CBT and an SSRI, alone or in combination, against a control condition
in the same patient population. This revised application proposes a four-year,
six site, randomized controlled efficacy trial comparing cognitive-behavioral (CBT) and pharmacological treatment for youth ages 7 to 16 years with anxiety
disorders. Phase 1 is a 12-week, random assignment acute efficacy study
comparing CBT, FLV, their combination (n=90, each condition), and pill placebo
control (n=48) in 318 (53/site) youth with DSM-IV primary diagnoses of
separation anxiety, social phobia, and/or generalized anxiety disorder. Phase
II involves a 6-month treatment maintenance period for Phase I responders. All
subjects regardless of response status will be evaluated at all scheduled
assessment points. In addition to comprehensive parent, child, clinician, and
teacher reports, the primary outcome variables will be assessed by blind
independent evaluators. Manualized intervention and assessment protocols plus
state-of-the-art quality assurance and adverse event monitoring procedures
insure uniform cross-site administration of the study protocol.
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