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NCT06217705 · ClinicalTrials.gov registry record · NA
Testing the Effects of Project Calm in Ukrainian Schools
A NA study, sponsored by Harvard University.
- Completed
- Registry status
- NA
- Development phase
- 728
- Enrollment target
NCT06217705: Completed NA study, sponsored by Harvard University.
NCT06217705 is a NA study that has completed, run by Harvard University. The registered enrollment target is 728 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06217705, a NA study, has completed, sponsored by Harvard University.
- COMPLETED
- Registry status
- NA
- Development phase
- 728 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effectiveness of a universal, digital, single-session intervention for youth mental health, functioning, and well-being, when implemented with Ukrainian children and adolescents. The intervention teaches well-established procedures that research has shown to be effective in helping American children calm themselves and regulate emotions, including slowed breathing and peaceful mental imagery. The intervention has not been tested previously with Ukrainian students. Participants will be provided access to this brief online program as part of the school curriculum. Students will be randomly assigned to receive the digital program either immediately or after 2 months. This 2-month lag will allow for evaluating the effectiveness of Project Calm in improving students' mental health, well-being, and self-calming skills. This will also allow for evaluating the effectiveness of such an intervention for war-exposed youths for whom these interventions may be especially helpful given the gap between these children's needs for mental health services and the very limited availability of clinicians
Primary Outcome
Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.
Interventions
- BEHAVIORAL Project Calm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 728 participants |
| Start Date | 2024-01-16 |
| Est. Completion | 2024-07-30 |
| Phase | NA |
What the finished NCT06217705 record still lists
NCT06217705 is an interventional study that assigns participants to a tested intervention. The registered 728 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Project Calm is the first listed.
NCT06217705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06217705 about?
NCT06217705 is a clinical study titled "Testing the Effects of Project Calm in Ukrainian Schools". The purpose of this study is to test the effectiveness of a universal, digital, single-session intervention for youth mental health, functioning, and well-being, when implemented with Ukrainian children and adolescents. The intervention teaches well-established procedures that research has shown to ...
What is the current status of trial NCT06217705?
This trial is currently completed. It is a NA study. The enrollment target is 728 participants. The study started on 2024-01-16. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT06217705?
The interventions under investigation include: Project Calm (BEHAVIORAL).
Who is sponsoring clinical trial NCT06217705?
This trial is sponsored by Harvard University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06217705's enrollment target sits among peer trials
728 145th of 2000 higher than 1,856 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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