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NCT03255122 · ClinicalTrials.gov registry record · NA
Technology and Early Anxiety Treatment
A NA study, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03255122: Completed NA study, sponsored by Florida International University.
NCT03255122 is a NA study that has completed, run by Florida International University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03255122, a NA study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
CGI-S/I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by IEs in the present study. The CGI-S score rates illness severity on a 7-point scale, ranging from 1 ("normal") to 7 ("among the most severely ill patients"). The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").
Interventions
- BEHAVIORAL I-CALM
- BEHAVIORAL Delayed I-CALM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2020-04-22 |
| Phase | NA |
What the finished NCT03255122 record still lists
NCT03255122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which I-CALM is the first listed.
NCT03255122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03255122 about?
NCT03255122 is a clinical study titled "Technology and Early Anxiety Treatment". 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 an...
What is the current status of trial NCT03255122?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2016-11-03. Estimated completion is 2020-04-22.
What interventions are being tested in trial NCT03255122?
The interventions under investigation include: I-CALM (BEHAVIORAL), Delayed I-CALM (BEHAVIORAL).
Who is sponsoring clinical trial NCT03255122?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03255122's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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