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Testing the Effects of Project Calm in Ukrainian Schools

NCT06217705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2024-08-13

No results posted yet for this 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

Conditions

Interventions

BEHAVIORAL

Project Calm

Project Calm is a \~30-minute self-guided digital intervention designed to teach children and adolescents empirically supported emotion regulation skills to facilitate self-calming when faced with intense negative emotions. Project Calm uses vignettes, interactive activities, and engaging graphics to teach youth calming skills.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2024-06-16
Completion
2024-07-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06217705 on ClinicalTrials.gov