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RECRUITING
NCT04693858
NA

Efficacy Trial of the CALM Intervention

Sponsor: UConn Health

View on ClinicalTrials.gov

Summary

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.

Official title: Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: an Efficacy Trial of the CALM Intervention

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2020-12-01

Completion Date

2026-07-30

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

Child Anxiety Learning Modules (CALM)

CALM is a cognitive-behavioral intervention for childhood anxiety. CALM consists of five modules. The primary components include psychoeducation, relaxation training (C), behavioral exposure (A), cognitive restructuring (L), and relapse prevention (M). There is also an optional parent psychoeducation module. Students randomized to the CALM condition will receive the 5 modules over 8 weeks.

BEHAVIORAL

Child Anxiety Learning Modules--Relaxation (CALM-R)

CALM-R serves as an active comparison condition to CALM and consists of 5 modules of relaxation skills. The key components of CALM-R include psychoeducation, deep breathing, progressive muscle relaxation, guided imagery, and relapse prevention. Students randomized to the CALM-R condition will receive the 5 modules over 8 weeks.

Locations (2)

University of Connecticut School of Medicine

West Hartford, Connecticut, United States

Anxiety Treatment Center of Maryland

Columbia, Maryland, United States