NCT03255122 is a NA clinical trial of I-CALM in Anxiety Disorders, sponsored by Florida International University.

Who is sponsoring NCT03255122?

NCT03255122 is sponsored by Florida International University.

What drugs are being tested in NCT03255122?

Interventions in NCT03255122: I-CALM, Delayed I-CALM.

What condition does NCT03255122 study?

NCT03255122 studies Anxiety Disorders.

Is NCT03255122 still recruiting?

NCT03255122 is currently completed. Last updated 2 July 2020.

Last reviewed 2020-07-02 · How we verify

NCT03255122

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Technology and Early Anxiety Treatment

Completed NA Last updated 2 July 2020

What this trial tests

NA trial testing I-CALM in Anxiety Disorders in 40 participants. Completed in 22 April 2020.

Timeline

3 November 2016

Primary endpoint
22 January 2020

22 April 2020

Quick facts

Lead sponsor	Florida International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	3 November 2016
Primary completion	22 January 2020
Estimated completion	22 April 2020
Sites	1 location across United States

Drugs / interventions tested

I-CALM
Delayed I-CALM

Conditions studied

Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

Florida International University

Who can join

Adults 3 to 8, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pediatric behavioral telehealth in the age of COVID-19: Brief evidence review and practice considerations.
Ros-DeMarize R, Chung P, Stewart R. · · 2021 · cited 44× · PMID 33436319 · DOI 10.1016/j.cppeds.2021.100949

Verify or expand the search:

Other recruiting trials for Anxiety Disorders

Currently open trials in the same condition.

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Other Florida International University trials

Trials by the same sponsor.

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NCT06489314 — Mental Health Treatment to Improve Father Depression and Child Outcomes in Kenya · NA · enrolling by invitation
NCT07199361 — Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation · NA · recruiting
NCT04571502 — Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care · NA · enrolling by invitation
NCT06637436 — PrEP Readiness Interventions for Sustained Motivation (PRISM) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03255122 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Florida International University
Last refreshed: 2 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03255122.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing