RecruitingNot ApplicableNCT04693858

Efficacy Trial of the CALM Intervention

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

Sponsor

UConn Health

Enrollment

218 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Anxiety Disorder of Childhood

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.

Eligibility

Min Age: 5 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests the effectiveness of an anxiety intervention program called CALM for children aged 5–12 who have elevated anxiety. The program uses structured techniques to help children and their parents manage anxiety symptoms. **You may be eligible if...** - Your child is between 5 and 12 years old - Your child has elevated anxiety symptoms (based on a screening questionnaire or clinical interview score) - Your child is fluent in English - If your child is already on anxiety medication or therapy, the dose has been stable for at least 4 weeks and no changes are planned during the 8-week program **You may NOT be eligible if...** - Your child's anxiety symptoms are below the study threshold - Your child has certain other primary diagnoses (such as autism or psychosis) that are the main focus of treatment - Your child is not fluent in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALChild 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.

BEHAVIORALChild 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

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