Efficacy Trial of the CALM Intervention

UConn Health

Status: Enrolling

Conditions: Anxiety Disorder of Childhood

Treatments: Behavioral: Child Anxiety Learning Modules (CALM); Behavioral: Child Anxiety Learning Modules--Relaxation (CALM-R)

Study type: Interventional

Funder types: Other

Identifiers

NCT04693858

R305A200195 (Other Grant/Funding Number)

21-037-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 3 patient groups

Child Anxiety Learning Modules (CALM)

Experimental group

Description:

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

Treatment:

Behavioral: Child Anxiety Learning Modules (CALM)

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

Active Comparator group

Description:

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

Treatment:

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

Waitlist control

No Intervention group

Description:

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.