- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217705
Testing the Effects of Project Calm in Ukrainian Schools
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Russia's invasion of Ukraine has deeply impacted the nation's children, perhaps most strikingly those who remain in Ukraine and are confronted by the trauma of war. 2.5 million have fled their homes, but even those still at home endure explosions, violence, loss of loved ones, and an estimated average of 900 hours hiding in bunkers. Research in Ukraine shows high levels of child mental health (MH) problems, including anxiety, depression, interpersonal stress, and difficulty regulating emotions. PI Weisz works with child MH researchers and clinicians from Ukraine and 5 other countries (the GROW consortium) to plan psychological support for these children. The group has concluded that Ukrainian-language digital MH interventions teaching evidence-based coping skills are the optimum form of early psychological support at this time, given the massive number of war-exposed Ukrainian children, the dearth of professional clinicians, and the ready accessibility of digital devices. Brief digital interventions (BDIs) for MH have been found effective with children in >90 randomized controlled trials (RCTs). They require no professional training or funding, and are easily implemented via digital devices used in nearly all schools. Ukrainian children may be helped via a BDI that teaches them evidence-based procedures for calming themselves when they experience distressing emotions.
The Harvard Lab for Youth Mental Health is collaborating with Ukrainian schools in the Zhytomyr region, which has been repeatedly targeted by Russian missiles since the first month of the invasion, spreading fear throughout the population and destroying airports, residential neighborhoods, hospitals, and at least one school. Children in Zhytomyr experience war-related MH problems identified in Ukrainian research reviews, including anxiety, sadness, and difficulty calming and regulating distressing negative emotions. Students will be offered a BDI that addresses these problems by teaching well-established skills that have robust empirical support: Project Calm teaches children to calm and regulate distressing emotions by using skills such as slowed breathing, relaxing of tense muscles, and peaceful mental imagery. This 30-minute BDI, which has been refined via student and school staff feedback over a 2-year period, is highly rated by children and teens, and has already been accessed >1000 times in North America.
Project Calm will be tested via an RCT with a time-matched, school-related control activity; students will be randomized 50/50 to complete Project Calm after the baseline assessment or after a 2-month lag. Students in grades 4-12 will complete MH, wellbeing, and BDI-skills measures at baseline and 1-, 2-, 3-, and 4-months post-baseline. Data collection will span January - June of 2024. Findings may point the way to a highly scalable, accessible, and disseminable approach to MH support-easily implemented in schools or community settings-that could benefit Ukrainian children and, with translation and adaptation, war-affected children of other nations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John R Weisz
- Phone Number: 6178777716
- Email: john_weisz@harvard.edu
Study Contact Backup
- Name: Joshua S Steinberg
- Phone Number: 6179453115
- Email: joshuasteinberg@g.harvard.edu
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02138
- Recruiting
- Harvard University
-
Contact:
- Joshua S Steinberg, BA
- Phone Number: 617-945-3115
- Email: joshuasteinberg@g.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Youth does not have access to a digital device
- Youth has an intellectual disability that precludes comprehension of the program content
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Other: Delayed Receipt of Project Calm Control Condition
No intervention for first two months; will receive Project Calm after 2-months and become a second-wave intervention condition.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavior and Feelings Survey (Internalizing Subscale)
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
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
Time Frame: Assessed immediately post-intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavior and Feelings Survey (Externalizing Subscale)
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Trajectories of self-reported misbehavior from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Externalizing 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
|
Emotion Regulation Mechanisms of Change Questions
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Emotion Regulation Mechanisms of Change Questions - Assessed at all time points via a novel 3-item measure (0-10 scale) evaluating participants' calming skills. Specific items include:
|
Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Youth Top Problems
Time Frame: Assessed at baseline
|
Assessed via the Youth Top Problems Assessment (Herren et al., 2018).
Items are rated on a scale from 0 (not a problem at all) to 4 (a very big problem).
|
Assessed at baseline
|
Peabody Treatment Progress Battery's Life Satisfaction Scale
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Assessed via the Peabody Treatment Progress Battery's Life Satisfaction Scale.
Items are rated on a scale from 1 (very dissatisfied) to 5 (very satisfied).
|
Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Treatment Expectancy Questions
Time Frame: Assessed immediately pre-intervention
|
Treatment expectations will be assessed at pre-intervention via a novel 4-item measure (0-10 scale) evaluating participants' expectations of intervention effects.
|
Assessed immediately pre-intervention
|
Sensitivity
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Assessed at all time points via the Highly Sensitive Person Scale (Baryla-Matejczuk et al., 2022).
Items are rated on a scale from 1 (not at all) to 7 (definitely).
|
Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
|
Trauma Symptoms
Time Frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups]
|
Assessed at all time points via the Short Post-Traumatic Stress Disorder Rating Interview (SPRINT-10; Connor & Davidson, 2001).
Items are rated on a scale from 0 (not at all) to 4 (very much).
|
Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups]
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB23-1653
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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