Co-Principal Investigator: Drake, Kelly

Purpose: Excessive anxiety among elementary students is highly prevalent and associated with impairment in academic, social, and behavioral functioning. The primary aim of this project is to evaluate the initial efficacy of a brief nurse-delivered intervention (CALM: Child Anxiety Learning Modules), relative to a credible comparison (CALM-R, relaxation skills only) for reducing anxiety symptoms and improving education outcomes at post intervention and at a 1-year follow-up. In addition, the research team will assess the cost effectiveness of CALM versus CALM-R and examine potential predictors, moderators, and mediators of CALM's impact on child outcomes based on the proposed theory of change.

Project Activities: Researchers will randomly assign 30 nurses to 1 of the 2 interventions and provide them with training to implement these interventions. Researchers will recruit students with elevated symptoms of anxiety to participate in the study. They will assess a set of outcomes related to anxiety and learning pre- and post-intervention. They will also gather information about the cost to implement both interventions.

Products: Products include information about the relative effectiveness of CALM versus CALM-R for reducing anxiety symptoms and improving education outcomes. Other products include information about costs and cost-effectiveness of the two interventions. Researchers will also produce peer-reviewed publications and a final publicly shared dataset based on the IES Public Access Policy.

Structured Abstract

Setting: The evaluation will take place in elementary schools in Connecticut and Maryland from urban, suburban, and rural areas.

Sample: Thirty elementary school nurses will be randomized and trained in 1 of the 2 interventions, and 218 children ages 5 to 12 with elevated symptoms of anxiety from participating schools will be recruited. Nurses and children of all races/ethnicities are eligible.

Intervention: CALM is a fully developed intervention that was developed and pilot tested with the support of an IES-funded Development grant. CALM consists of five modules based on empirically supported cognitive behavioral strategies. Data from the IES-funded pilot RCT demonstrated the feasibility of the nurse training and intervention in an authentic school setting, adequate nurse fidelity, and promising positive changes on key student outcomes and across multiple informants.

Research Design and Methods: A clustered randomized controlled design will be used to compare the impact of CALM to CALM-R on student anxiety symptoms and academic, social, and behavioral functioning.

Control Condition: CALM-R is an active, credible comparison condition. It consists of five modules (to control for time with nurse) and is based on relaxation skills only, to mimic what some nurses already use with students.

Key Measures: Key outcome measures will assess reductions in anxiety symptoms (such as using the Clinical Global Impressions Severity and Improvement Scales measured by independent evaluators) and improvements in academic functioning (such as using the Academic Competence Evaluation Scalemeasured by teachers blind to intervention condition). Additional outcomes (such as grades, school attendance) and mediators (such as behavioral avoidance, somatic symptoms, maladaptive cognitions) are assessed using multiple informants and methods.

Data Analytic Strategy: The impact of the intervention on anxiety symptoms and educational outcomes will be assessed using multilevel mixed effect models and three time points: pre-intervention, post-intervention, and follow-up. The hierarchical model will have two levels, with children's scores on the first level and being clustered within nurse on the second level. The team will include both child-level and nurse-level covariates.

Cost Effectiveness Analyses: A secondary aim of this project is to examine the cost effectiveness of CALM versus CALM-R. Data will be collected from multiple sources to analyze the incremental cost-effectiveness ratio, intervention and implementation costs, and willingness to pay from school administrators.

Related Projects: Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children (R305A140694)