Clinical trial NCT04693858: Efficacy Trial of the CALM Intervention
Official title: Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: an Efficacy Trial of the CALM Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder of Childhood
Keywords: Anxiety
Child anxiety
School-based interventions
School nursing
Brief anxiety interventions
Cognitive-behavioral therapy
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 218
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline
timeFrame: 8 weeks after baseline
measure: Clinical Global Impression - Impairment (CGI-I) Scale, 12-month follow-up
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Children's Somatization Inventory (CSI-24)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Behavioral Avoidance
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Children's Automatic Thoughts Scale (CATS)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Student Attendance Form
timeFrame: Two weeks prior to the evaluations
measure: School Attendance and Discipline
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Student school records - attendance
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Student school records - disciplinary actions
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Student school records - grades
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Student school records - special education
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Subtests from the Woodcock-Johnson Tests -Achievement and Cognitive Batteries (WJ IV)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Strength and Difficulties Questionnaire (SDQ), Teacher and Parent Versions
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Teacher Observation of Classroom Adaptation-Checklist Concentration subscale (TOCA-C)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Academic Competence Evaluation Scale (ACES), short version
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Child Anxiety Impact Scale (CAIS)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: School Anxiety Scale - Teacher Report (SAS-TR)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Clinical Global Impression - Severity (CGI-S) Scale
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Screen for Child Anxiety-Related Emotional Disorders (SCARED), parent and child versions
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
Other outcomes:
measure: CALM and CALM-R Intervention Fidelity, Adherence, Differentiation, and Competence
timeFrame: 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)
measure: Independent Evaluator (IE) masking form
timeFrame: After post (8-week) and follow up (12-month) evaluations
measure: Session Summary Form (SSF)
timeFrame: 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)
measure: Nurse Background Form
timeFrame: Baseline
measure: Maslach Burnout Inventory - General Survey
timeFrame: Baseline, 8 weeks after baseline (with each child), 12-month follow-up
measure: Student-Nurse Relationship Scale -Closeness Subscales, student and nurse reports
timeFrame: Baseline, 8 weeks after baseline
measure: Family demographic form
timeFrame: Baseline
measure: Willingness-to-Pay (WTP) questionnaire
timeFrame: At the conclusion of the CALM study (4 years following the beginning of the study)
measure: Child Health Utility 9-D Index (CHUD)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Child and Adolescent Services Assessment (CASA)
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Parent's missed work form
timeFrame: Baseline, 8 weeks after baseline, 12-month follow-up
measure: Nurse time logs
timeFrame: Baseline, weekly, 8 weeks after baseline, 12-month follow-up
Locations:
city: West Hartford
country: United States
facility: University of Connecticut School of Medicine
state: Connecticut
city: Columbia
country: United States
facility: Anxiety Treatment Center of Maryland
state: Maryland
Study officials:
affiliation: UConn Health
name: Golda S Ginsburg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Kelly Drake, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.