Efficacy Trial of the CALM Intervention (NCT04693858)
Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Efficacy Trial of the CALM Intervention
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Connecticut School of Medicine — West Hartford, Connecticut
Age range: 5 Years to 12 Years
🧪 Interventions in This Study
- Child Anxiety Learning Modules (CALM) (BEHAVIORAL)
- Child Anxiety Learning Modules--Relaxation (CALM-R) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Connecticut School of Medicine — West Hartford, Connecticut
- Anxiety Treatment Center of Maryland — Columbia, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Anxiety Disorder of Childhood
- Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study — Boston, Massachusetts
Explore by condition: All Anxiety Disorder of Childhood clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.