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Efficacy Trial of the CALM Intervention

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Jul 3, 2026 → Aug 3, 2027
See other at-risk trials from UConn Health

Record History

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  1. Primary completion pushed from Jul 3, 2026 to Aug 3, 2027
    • Enrollment closed, study ongoing
    • Study completion pushed from Jul 30, 2026 to Aug 30, 2027
    • Site details revised at 2 of 2 sites
    v5
  2. Primary completion date: Jun 3, 2025 to Jul 3, 2026
    • Study completion date: Jul 30, 2025 to Jul 30, 2026
    • Site contacts updated at 2 of 2 sites
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary completion date: Jun 3, 2024 to Jun 3, 2025
    • Study completion date: Jun 3, 2024 to Jul 30, 2025
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 3 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UConn Health
38 trials monitored
See 2 trials at risk
Anxiety
3,263 trials monitored
See 159 trials at risk
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.
Trial Details
NCT Number NCT04693858
Lead Sponsor UConn Health
Conditions
(from sponsor)		 Anxiety Disorder of Childhood
Related terms Anxiety Disorders
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov