Efficacy Trial of the CALM Intervention

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) and a waitlist control 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 the waitlist control and examine potential predictors, moderators, and mediators of CALM's impact on child outcomes based on the proposed theory of change.

NCT Number	NCT04693858
Lead Sponsor	UConn Health
Conditions	Anxiety Disorder of Childhood
Enrollment	218 participants
Start Date	2020-12-01
Primary Completion	2027-08-03 (estimated)
Study Completion	2027-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-12