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Efficacy Trial of the CALM Intervention
NCT04693858 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Child Anxiety Learning Modules (CALM)
- BEHAVIORAL Child Anxiety Learning Modules--Relaxation (CALM-R)
Study Locations (2)
Connecticut
- University of Connecticut School of Medicine — West Hartford
Maryland
- Anxiety Treatment Center of Maryland — Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2026-07-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04693858
The ClinicalTrials.gov registry entry for NCT04693858 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UConn Health, which has 176 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Anxiety Disorder of Childhood appearing as the primary indexed condition, and to 2 interventions — of which Child Anxiety Learning Modules (CALM) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04693858 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Connecticut, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04693858 about?
NCT04693858 is a clinical study titled "Efficacy Trial of the CALM Intervention". 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...
What is the current status of trial NCT04693858?
This trial is currently recruiting. It is a NA study. The enrollment target is 218 participants. The study started on 2020-12-01. Estimated completion is 2026-07-30.
What conditions does trial NCT04693858 study?
This clinical trial studies the following conditions: Anxiety Disorder of Childhood. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04693858?
The interventions under investigation include: Child Anxiety Learning Modules (CALM) (BEHAVIORAL), Child Anxiety Learning Modules--Relaxation (CALM-R) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04693858?
This trial is sponsored by UConn Health, which has 176 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04693858 being conducted?
This trial has 2 study locations across Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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