Evaluating a nurse-delivered intervention for childhood anxiety
Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: an Efficacy Trial of the CALM Intervention
This study tests if a program delivered by school nurses can help reduce anxiety in elementary students better than relaxation techniques or no treatment at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | UConn Health Academic / other |
| Locations | 2 sites (West Hartford, Connecticut and 1 other locations) |
| Trial ID | NCT04693858 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the efficacy of the Child Anxiety Learning Modules (CALM), a brief intervention delivered by school nurses, in reducing anxiety symptoms among elementary students. The study compares CALM to a relaxation skills intervention (CALM-R) and a waitlist control group, measuring outcomes immediately after the intervention and at a one-year follow-up. Additionally, the research will evaluate the cost-effectiveness of CALM and explore factors that may influence its effectiveness on child outcomes. The intervention addresses the critical need for accessible anxiety support in schools, particularly given the high prevalence of anxiety among children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-12 who exhibit elevated anxiety symptoms.
Not a fit: Patients who do not meet the inclusion criteria for elevated anxiety symptoms or are not fluent in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety symptoms in children, leading to improved academic and social functioning.
How similar studies have performed: Other studies have shown promise in using school-based interventions for anxiety, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
West Hartford, Connecticut and 1 other locations
- University of Connecticut School of Medicine — West Hartford, Connecticut, United States (Recruiting)
- Anxiety Treatment Center of Maryland — Columbia, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Golda S Ginsburg, Ph.D. — UConn Health
- Study coordinator: Golda S Ginsburg, Ph.D.
- Email: gginsburg@uchc.edu
- Phone: 8605233788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.