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
2 other identifiers
interventional
218
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
December 9, 2024
December 1, 2024
5.6 years
December 14, 2020
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (19)
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
- +14 more secondary outcomes
Other Outcomes (12)
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)
- +9 more other outcomes
Study Arms (3)
Child Anxiety Learning Modules (CALM)
EXPERIMENTALChildren randomly assigned to this condition will receive the CALM intervention.
Child Anxiety Learning Modules--Relaxation (CALM-R)
ACTIVE COMPARATORChildren randomly assigned to this condition will receive the CALM-R intervention.
Waitlist control
NO INTERVENTIONWithin 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Be between the ages of 5-12
- Have elevated anxiety symptoms as indicated by a) a total SCARED score of 15 or higher based on parent and/or child report using the full SCARED from the baseline evaluation, and/or b) a Clinician Severity Rating of 3 or higher on any anxiety diagnosis from the Anxiety Disorders Interview Schedule for Children DSM-V (ADIS)
- Be fluent in English in order to provide informed consent and assent for their participation and to complete the study measures.
- Children on a stable dose of pharmacological/psychotherapeutic treatment will be eligible as long as the dose has been stable for at least 4 weeks and no changes are considered for the duration of the intervention phase of the study (8 weeks)
You may not qualify if:
- Nurses must be a Registered Nurse (RN) or another similar medical professional
- Nurses must be work in the role of a school nurse
- Nurses must be fluent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
Study Sites (2)
University of Connecticut School of Medicine
West Hartford, Connecticut, 06119, United States
Anxiety Treatment Center of Maryland
Columbia, Maryland, 21045, United States
Related Publications (3)
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.
PMID: 31373524BACKGROUNDDrake 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.
PMID: 26171792BACKGROUNDMuggeo, 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Golda S Ginsburg, Ph.D.
UConn Health
- PRINCIPAL INVESTIGATOR
Kelly Drake, Ph.D.
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Independent Evaluators (IEs) responsible for baseline, post-intervention, and follow-up outcomes assessment will be masked to intervention conditions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 14, 2020
First Posted
January 5, 2021
Study Start
December 1, 2020
Primary Completion (Estimated)
July 3, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
December 9, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The de-identified data and documentation files will be available after the final wave of data are collected, cleaned, and the primary outcome manuscript has been accepted for publication. The data will remain accessible for at least 10 years and the timeframe of data accessibility will be reviewed at the annual progress reviews and revised as necessary.
- Access Criteria
- A a CALM Data Request Form will be required from interested individuals. Data will be sent under conditions that the request is reasonable and will be provided to qualified researchers or allied professionals with the necessary skills to use and interpret the data responsibly.
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.