Prevention of Anxiety in High-Risk Pre-School Children

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DESCRIPTION (provided by applicant): Anxiety disorders are one of the more prevalent psychiatric conditions. They typically have an onset in childhood and then follow a chronic and fluctuating course into adulthood. Despite an established literature on psychotherapy with anxious adults and older children, there is little data on the efficacy of any treatments for anxiety in children prior to age 7. There are no controlled anxiety prevention trials in US samples of any age. Given the high prevalence, early onset, and impairing consequences of untreated anxiety, public health strategies that would allow early identification and intervention are clearly warranted. This R34 proposal will develop an indicated prevention for pre-school children with significant subthreshold anxiety and then obtain data on its feasibility, acceptability and potential efficacy. In Phase 1 of the study, we will create a manualized intervention for anxious preschoolers and their parents, establish recruitment procedures, conduct training of therapists and evaluators, and carry out an initial open pilot trial of the intervention with 10 children and their families. In Phase 2, we will screen 4-year-old children attending public school Pre-K programs in NYC. We will recruit 64 subjects with persistently elevated levels of anxiety, who do not currently meet diagnostic criteria for a DSM-IV anxiety or mood disorder, and randomize them to a 12-week intervention or a wait-list control condition. All subjects will be assessed at baseline, immediately pre- and post-intervention and at 3-month follow-up. The goal of this study is to inform the design of a full-scale intervention trial (R01) through evaluating recruitment, program feasibility and acceptability, attrition rates, missing data patterns and estimating intervention effect sizes on primary outcomes (child anxiety and social functioning) and targeted proximal risk factors (parenting and child socio-emotional functioning).