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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 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. The trial reports 2 study locations across 2 states.

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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.

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

FieldValue
Enrollment Target 218 participants
Start Date 2020-12-01
Est. Completion 2026-07-30
Phase NA

Sponsor

UConn Health

178 total trials

What the Registry Record Tells You About NCT04693858

The ClinicalTrials.gov registry entry for NCT04693858 describes a study currently listed as recruiting, categorized as NA. 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 178 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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