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Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Efficacy Trial of the CALM Intervention
Clinical Trial ( IRB ) #: 21-037S-2
Title: Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Efficacy Trial of the CALM Intervention
Principal Investigator: Dr. Golda Ginsburg
Description: Project Summary/Abstract Title: Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Initial Efficacy Trial of the CALM Intervention Topic and Project Type: Education Research Grant, CFDA Number: 84.305A, Social and Behavioral Context for Academic Learning, Project Type: Initial Efficacy Purpose of the project: 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 educational outcomes at post intervention and at a one year follow-up. In addition, we 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. Setting: Elementary schools in Connecticut and Maryland from urban, suburban, and rural areas. Sample: 30 elementary school nurses will be randomized and trained in one of the two interventions; 218 children ages of 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 pilot tested with the support of an IES-funded Goal 2 grant. CALM consists of five modules based on empirically supported cognitive behavioral strategies. Data from our 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. 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. 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. Key measures and outcomes: Key outcome measures will assess reductions in anxiety symptoms (e.g., using the Clinical Global Impressions Severity and Improvement Scales measured by independent evaluators) and improvements in academic functioning (e.g., using the Academic Competence Evaluation Scale measured by teachers blind to intervention condition). Additional outcomes (e.g., grades, school attendance) and mediators (e.g., 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, post and follow-up. Our hierarchical model will have two levels, with children';s scores on the first level and being clustered within nurse on the second level. We 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.
Classification:
  Anxiety Disorders
  Psychiatry - Child and Adolescent
Eligibility Criteria: Check with study contact
How to Contact: Thomas Harrison. Telephone: 860-523-3788. Email: tharrison@uchc.edu or Carissa Orlando. Telephone: 860-523-3788. Email: corlando@uchc.edu or Isaac Smith. Telephone: 860-523-6476. Email: issmith@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.