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Efficacy Trial of the CALM Intervention

NCT ID: NCT04693858

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2026-07-30

Brief Summary

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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.

Detailed Description

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Excessive anxiety among elementary age students is common, severely impairs academic, social, and behavioral functioning, and is associated with significant educational and health care costs. Despite the high burden of anxiety, less than half of children with anxiety receive the services they need to succeed in school. School clinicians can and do support these youth, however, their caseloads are high and their time to provide individualized services is limited. Consequently, there is a critical need to expand the network of providers who can assist students with anxiety and address this malleable obstacle to student academic success. Because somatic complaints, such as headaches and stomach aches, are a hallmark feature of excessive anxiety, school nurses are often the first school-based personnel to identify problematic anxiety in students. However, school nurses currently lack training in evidenced-based anxiety reduction interventions. The current study leverages findings from a three-year IES Development award (R305A140694), through which our team developed and assessed the feasibility of training elementary school nurses to use a brief intervention to reduce student anxiety; it was demonstrated that the training and intervention (i.e., Child Anxiety Learning Modules; CALM) was indeed feasible to implement and resulted in positive changes in student outcomes. CALM is now a fully developed intervention with ready-to-use intervention components and materials, training and coaching procedures, and is ready for an initial efficacy evaluation in authentic school settings. Toward that end, the primary purpose of this study is to evaluate the efficacy of CALM in a fully powered randomized controlled trial. CALM will be delivered by elementary school nurses in rural, suburban, and urban elementary schools nationwide to enhance the generalizability of findings across socioeconomic, racial, ethnic, and neighborhood settings (as approximately 80% of schools in the US have a school nurse). The efficacy of CALM will be tested using gold standard methods (e.g., independent evaluators to assess primary outcomes). The study's primary aim is to evaluate the efficacy of CALM, compared to a credible comparison condition (CALM-R; a school nurse delivered relaxation skills only intervention that parallels CALM in time and format) as well as a waitlist control, for reducing anxiety symptoms and improving educational outcomes at post-intervention and a one year follow-up. The secondary aim is to examine the cost effectiveness of CALM relative to CALM-R and the waitlist control. An exploratory aim is to examine potential predictors, moderators, and mediators of student outcomes based on the proposed theory of change. If efficacious, CALM will be the first evidenced-based school nurse delivered intervention to assist youth with excessive anxiety, filling an important gap in current practices.

Conditions

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Anxiety Disorder of Childhood

Keywords

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Anxiety Child anxiety School-based interventions School nursing Brief anxiety interventions Cognitive-behavioral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study involves a cluster-randomized controlled trial to compare CALM to CALM-R and a weighted waitlist control (WLC) group (4 CALM/CALM-R:1 WLC).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The Independent Evaluators (IEs) responsible for baseline, post-intervention, and follow-up outcomes assessment will be masked to intervention conditions.

Study Groups

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Child Anxiety Learning Modules (CALM)

Children randomly assigned to this condition will receive the CALM intervention.

Group Type EXPERIMENTAL

Child Anxiety Learning Modules (CALM)

Intervention Type BEHAVIORAL

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.

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

Children randomly assigned to this condition will receive the CALM-R intervention.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

Waitlist control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)



* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Golda S. Ginsburg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Golda S Ginsburg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Kelly Drake, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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University of Connecticut School of Medicine

West Hartford, Connecticut, United States

Site Status RECRUITING

Anxiety Treatment Center of Maryland

Columbia, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Golda S Ginsburg, Ph.D.

Role: CONTACT

Phone: 8605233788

Email: [email protected]

Kelly Drake, Ph.D.

Role: CONTACT

Phone: 4108007591

Email: [email protected]

Facility Contacts

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Golda Ginsburg, Ph.D.

Role: primary

Role: backup

Golda Ginsburg

Role: backup

Kelly Drake, Ph.D.

Role: primary

Role: backup

Kelly Drake, Ph.D.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 31373524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26171792 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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R305A200195

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

21-037-2

Identifier Type: -

Identifier Source: org_study_id