Testing the Effects of Project Calm in Ukrainian Schools

NCT06217705 | Completed

• 1 other identifier: IRB23-1653
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

Brief 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

Trauma; Anxiety; Depression; Child Behavior

Outcome Measures

Primary Outcomes (2)

• Change in Behavior and Feelings Survey (Internalizing Subscale)

  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.

  Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

• Perceived Program Acceptability and Helpfulness

  Post-intervention feedback on the program's perceived acceptability and helpfulness as measured via a 7-item measure, with each item rated on a 1-5 scale, with higher scores indicating greater acceptability and helpfulness.

  Assessed immediately post-intervention

Secondary Outcomes (7)

• Change in Behavior and Feelings Survey (Externalizing Subscale)

  Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

• Emotion Regulation Mechanisms of Change Questions

  Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

• Youth Top Problems

  Assessed at baseline

• Peabody Treatment Progress Battery's Life Satisfaction Scale

  Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

• Treatment Expectancy Questions

  Assessed immediately pre-intervention

Study Arms (2)

Project Calm

EXPERIMENTAL

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.

Behavioral: Project Calm

Delayed Receipt of Project Calm Control Condition

OTHER

No intervention for first two months; will receive Project Calm after 2-months and become a second-wave intervention condition.

Behavioral: Project Calm

Interventions

Project Calm BEHAVIORAL

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.

Delayed Receipt of Project Calm Control Condition; Project Calm

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth in grades 4+ at partnering schools for Ukrainian children
• Youth and at least one guardian consent to adolescent participation in study
• Youth reads Ukrainian well enough to effectively complete the digital programs
• Youth has access to a digital device

You may not qualify if:

• Youth does not have access to a digital device
• Youth has an intellectual disability that precludes comprehension of the program content

Sponsors & Collaborators

• Harvard University: lead
• John Weisz: collaborator

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• Steinberg JS, Sun J, Venturo-Conerly KE, Sood G, Mair P, Davydenko O, Porzak R, Ougrin D, Weisz JR. Randomized trial testing a self-guided digital mental health intervention teaching calming skills for Ukrainian children. Npj Ment Health Res. 2025 May 16;4(1):20. doi: 10.1038/s44184-025-00134-w.

  PMID: 40379908 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Anxiety Disorders; Depression; Child Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be completed independently by participants online. Investigators will be blinded to condition throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to receive the intervention condition (Project Calm) immediately or after two months. Participants in the delayed Calm condition will complete a typical school activity instead (i.e., treatment as usual). All participants will complete survey measures online at baseline, immediately after receiving the intervention, and 1-, 2, 3-, and 4-months after baseline.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 22, 2024
• Study Start: January 16, 2024
• Primary Completion: June 16, 2024
• Study Completion: July 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

US (1)