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NCT04693858 · ClinicalTrials.gov registry record · NA
Efficacy Trial of the CALM Intervention
A NA study of Anxiety Disorder of Childhood, sponsored by UConn Health.
- Recruiting
- Registry status
- NA
- Development phase
- 218
- Enrollment target
- 2
- Study locations
NCT04693858: Recruiting NA study of Anxiety Disorder of Childhood, sponsored by UConn Health.
NCT04693858 is a NA study of Anxiety Disorder of Childhood that is actively recruiting participants, run by UConn Health. The registered enrollment target is 218 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04693858, a NA study of Anxiety Disorder of Childhood, is actively recruiting participants, sponsored by UConn Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 218 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The CGI-I provides a global rating of improvement in anxiety, relative to baseline. The measure yields a single rating of clinical improvement during the past week, relative to the baseline rating. Scores range from 1 (very much improved) to 7 (very much worse).
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 |
What NCT04693858 shows while recruiting
NCT04693858 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
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.
NCT04693858 reports a single indexed study location in Connecticut, Maryland.
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.
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).
Who is sponsoring clinical trial NCT04693858?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04693858's enrollment target sits among peer trials
218 485th of 2000 higher than 1,516 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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