NCT04693858|Active Not Recruiting
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
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Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Efficacy Trial of the CALM Intervention
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Institute of Education Sciences
interventional
218
1 country
2
Study Start
December 1, 2020
Actual (reported)Primary Completion
August 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2020
Actual (reported)December 14, 2020
Actual (reported)January 5, 2021
Actual (reported)August 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline
The CGI-I provides a global rating of improvement in anxiety, relative to baseline. The measure yields a single rating of clinical improvement during the past week, relative to the baseline rating. Scores range from 1 (very much improved) to 7 (very much worse).
8 weeks after baseline
Clinical Global Impression - Impairment (CGI-I) Scale, 12-month follow-up
The CGI-I provides a global rating of improvement in anxiety, relative to baseline. The measure yields a single rating of clinical improvement during the past week, relative to the baseline rating. Scores range from 1 (very much improved) to 7 (very much worse).
12-month follow-up
Children's Somatization Inventory (CSI-24)
Baseline, 8 weeks after baseline, 12-month follow-up
Behavioral Avoidance
Baseline, 8 weeks after baseline, 12-month follow-up
Children's Automatic Thoughts Scale (CATS)
Baseline, 8 weeks after baseline, 12-month follow-up
Children's Global Assessment Scale (CGAS)
Baseline, 8 weeks after baseline, 12-month follow-up
Student Attendance Form
Two weeks prior to the evaluations
CALM and CALM-R Intervention Fidelity, Adherence, Differentiation, and Competence
After each session of the CALM or CALM-R intervention is delivered (approximately 1 session of the intervention delivered each week, for up to 8 weeks)
Independent Evaluator (IE) masking form
After post (8-week) and follow up (12-month) evaluations
Session Summary Form (SSF)
After each session of the CALM or CALM-R intervention is delivered (approximately 1 session of the intervention delivered each week, for up to 8 weeks)
Children randomly assigned to this condition will receive the CALM intervention.
Children randomly assigned to this condition will receive the CALM-R intervention.
Within each nurse, 20% (1 in 5) children will be randomly assigned to wait a period of eight weeks prior to starting the intervention with their school nurse. During this period, the child is not prevented from seeing the school nurse, nor are they prevented from continuing to utilize stable doses of community treatment (i.e., therapy outside of school or medication); nurses are simply asked to provide normal support and avoid using techniques specific to CALM or CALM-R. After the 8 weeks, youth are re-evaluated and nurses begin delivering the intervention to the student.
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.
University of Connecticut School of Medicine
West Hartford, Connecticut, 06119, United States
Anxiety Treatment Center of Maryland
Columbia, Maryland, 21045, United States
Ginsburg GS, Drake KL, Muggeo MA, Stewart CE, Pikulski PJ, Zheng D, Harel O. A pilot RCT of a school nurse delivered intervention to reduce student anxiety. J Clin Child Adolesc Psychol. 2021 Mar-Apr;50(2):177-186. doi: 10.1080/15374416.2019.1630833. Epub 2019 Aug 2.
Drake KL, Stewart CE, Muggeo MA, Ginsburg GS. Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: Development of the CALM Intervention. J Child Adolesc Psychiatr Nurs. 2015 Aug;28(3):121-30. doi: 10.1111/jcap.12115. Epub 2015 Jul 14.
Golda S Ginsburg, Ph.D.
UConn Health
Kelly Drake, Ph.D.
Johns Hopkins University
First Submitted
December 14, 2020
First Posted
January 5, 2021
Study Start
December 1, 2020
Actual (reported)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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Muggeo, M. A., Stewart, C. E., Drake, K. L., & Ginsburg, G. S. (2017). A school nurse-delivered intervention for anxious children: An open trial. School Mental Health, 9(2) 157-171.
Primary Completion
August 3, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 12, 2026
Record last verified: 2026-08
1. Publications: we will submit all publications to the ERIC within 12 months of the publisher's official date of final publication. We will also email copies of publications to interested parties upon request. 2. Data Access/Sharing: We will provide timely access to the final research data (including data file in SPSS format and a variable codebook). We will share only cleaned, de-identified or synthetic data. These data include surveys/interviews and school records. We will create a data documentation file (i.e., description of all original and derived/summary variables and definitions) to accompany the data file. The documentation will include a description of the study, data collection forms, study protocol/procedures, descriptions of variable recoding performed, and a list of major study publications and investigators.
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Source: ClinicalTrials.gov.
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