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NCT04693858
Efficacy Trial of the CALM Intervention
NA trial testing Child Anxiety Learning Modules (CALM) in Anxiety Disorder of Childhood in 218 participants. Currently enrolling.
3 July 2026
Quick facts
| Lead sponsor | UConn Health |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 218 |
| Start date | 1 December 2020 |
| Primary completion | 3 July 2026 |
| Estimated completion | 30 July 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Child Anxiety Learning Modules (CALM)
- Child Anxiety Learning Modules--Relaxation (CALM-R)
Conditions studied
- Anxiety Disorder of Childhood — all drugs for Anxiety Disorder of Childhood →
Sponsor
UConn Health — full company profile →
Who can join
Adults 5 to 12, any sex, with Anxiety Disorder of Childhood. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04693858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Anxiety Disorder of Childhood
Currently open trials in the same condition.
- NCT05967468 — Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder · NA · active not recruiting
- NCT04039243 — Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study · NA · active not recruiting
Other UConn Health trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04693858 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UConn Health
- Last refreshed: 9 December 2024
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/NCT04693858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing