Status:
RECRUITING
Efficacy Trial of the CALM Intervention
Lead Sponsor:
UConn Health
Conditions:
Anxiety Disorder of Childhood
Eligibility:
All Genders
5-12 years
Phase:
NA
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 initi...
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 ...
Eligibility Criteria
Inclusion
- Student
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04693858
Start Date
December 1 2020
End Date
July 30 2026
Last Update
December 9 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Connecticut School of Medicine
West Hartford, Connecticut, United States, 06119
2
Anxiety Treatment Center of Maryland
Columbia, Maryland, United States, 21045