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Efficacy Trial of the CALM Intervention

NCT04693858 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Anxiety Disorder of Childhood

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.

Sponsors & Collaborators

  • UConn Health

    lead OTHER

Principal Investigators

  • Golda S Ginsburg, Ph.D. · UConn Health

  • Kelly Drake, Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2026-07-03
Completion
2026-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693858 on ClinicalTrials.gov