TraumaNCT06217705
Testing the Effects of Project Calm in Ukrainian Schools
A study testing Project Calm in people with Trauma and Anxiety, run by Harvard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Anxiety, Depression
- What is being tested?
- Project Calm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Youth does not have access to a digital device
- Youth has an intellectual disability that precludes comprehension of the program content
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Trauma, Anxiety, Depression, Child Behavior
- Being tested
- Project Calm
- Medical subject headings
- Wounds and Injuries, Anxiety Disorders, Depression, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project CalmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Project Calm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed immediately post-intervention
Secondary outcomes (7)
Change in Behavior and Feelings Survey (Externalizing Subscale)
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.
Measured: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
Emotion Regulation Mechanisms of Change Questions
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:
- When I feel tense or nervous, I can calm myself.
- When I feel scared, I can calm myself.
- When I feel angry, I can calm myself.
Measured: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
Youth Top Problems
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).
Measured: Assessed at baseline
Peabody Treatment Progress Battery's Life Satisfaction Scale
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).
Measured: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
Treatment Expectancy Questions
Treatment expectations will be assessed at pre-intervention via a novel 4-item measure (0-10 scale) evaluating participants' expectations of intervention effects.
Measured: Assessed immediately pre-intervention
Sensitivity
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).
Measured: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups
Trauma Symptoms
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).
Measured: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Jan 2024
- Primary completion16 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- John Weisz
- Responsible party
- Principal investigator, John Weisz, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217705
- Sponsor's protocol ID
- IRB23-1653
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Analytic code will be made available upon publication of trial results. Study protocol and statistical plan are available on Open Science Framework.
Publications
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.
PubMed 40379908
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of Project Calm in Ukrainian Schools
- ClinicalTrials.gov ID
- NCT06217705
- Acronym / sponsor ID
- IRB23-1653
- Conditions
- Trauma, Anxiety, Depression, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- John Weisz
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Project Calm | Experimental | Behavioral: Project CalmProject 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 | Other | Behavioral: Project CalmNo intervention for first two months; will receive Project Calm after 2-months and become a second-wave intervention condition. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Youth does not have access to a digital device
- Youth has an intellectual disability that precludes comprehension of the program content
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project CalmProject 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. | Behavioural | Delayed Receipt of Project Calm Control Condition, Project Calm |
Primary outcome
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.
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.
7 secondary outcomes
Change in Behavior and Feelings Survey (Externalizing Subscale)
Time frame: 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
Youth Top Problems
Time frame: 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
Treatment Expectancy Questions
Time frame: Assessed immediately pre-intervention
Sensitivity
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 40379908Steinberg 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.
- Individual participant dataSharing planned: Undecided. Analytic code will be made available upon publication of trial results. Study protocol and statistical plan are available on Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Calm in people with Trauma and Anxiety, run by Harvard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavior and Feelings Survey (Internalizing Subscale) (time frame: Assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.