Actively Recruiting
Efficacy Trial of the CALM Intervention
Led by UConn Health · Updated on 2024-12-09
218
Participants Needed
2
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Efficacy Trial of the CALM Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between the ages of 5 and 12
- Have elevated anxiety symptoms indicated by a total SCARED score of 15 or higher from parent or child report, and/or a Clinician Severity Rating of 3 or higher on any anxiety diagnosis from the Anxiety Disorders Interview Schedule for Children DSM-V
- Be fluent in English to provide consent, assent, and complete study measures
- Children on a stable dose of pharmacological or psychotherapeutic treatment for at least 4 weeks with no planned changes during the 8-week intervention
- Nurses must be Registered Nurses or similar medical professionals
- Nurses must work as school nurses
- Nurses must be fluent in English
You will not qualify if you...
- Children who do not meet the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Connecticut School of Medicine
West Hartford, Connecticut, United States, 06119
Actively Recruiting
2
Anxiety Treatment Center of Maryland
Columbia, Maryland, United States, 21045
Actively Recruiting
Research Team
G
Golda S Ginsburg, Ph.D.
CONTACT
K
Kelly Drake, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here