Efficacy Trial of the CALM Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Child Anxiety Learning Modules (CALM), Child Anxiety Learning Modules--Relaxation (CALM-R).
- Who it may be relevant to
- Registry conditions: Anxiety Disorder of Childhood. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: an Efficacy Trial of the CALM Intervention
Overview
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
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.
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.
Primary outcome measures
- Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline [Time frame: 8 weeks after baseline]
- Clinical Global Impression - Impairment (CGI-I) Scale, 12-month follow-up [Time frame: 12-month follow-up]
Secondary outcome measures (12)
- Children's Somatization Inventory (CSI-24) [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Behavioral Avoidance [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Children's Automatic Thoughts Scale (CATS) [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Children's Global Assessment Scale (CGAS) [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Student Attendance Form [Time frame: Two weeks prior to the evaluations]
- School Attendance and Discipline [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Student school records - attendance [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Student school records - disciplinary actions [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Student school records - grades [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Student school records - special education [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Subtests from the Woodcock-Johnson Tests -Achievement and Cognitive Batteries (WJ IV) [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
- Strength and Difficulties Questionnaire (SDQ), Teacher and Parent Versions [Time frame: Baseline, 8 weeks after baseline, 12-month follow-up]
Eligibility criteria
Student 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)
Student Exclusion Criteria:
- Children who do not meet the inclusion criteria
Nurse Inclusion Criteria:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Connecticut School of Medicine — West Hartford
- Anxiety Treatment Center of Maryland — Columbia
Publications
- 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 31373524
- 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. PMID 26171792
- 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.
Identifiers
NCT: NCT04693858 · 21-037-2 · R305A200195