TraumaNCT06064578
The Ukrainian Student Problem Solving Project
A study testing Project SOLVE 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. The investigators will be providing access to a brief online program (Project SOLVE) for students as part of the school curriculum. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Anxiety, Depression
- What is being tested?
- Project SOLVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 30 Jun 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth in grades 5+ 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
Official title: The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth
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. The investigators will be providing access to a brief online program (Project SOLVE) for students as part of the school curriculum. Ukrainian students living in Poland will be randomly assigned to receive Project SOLVE either immediately or after 3 months. The program is designed to help students manage stress and reach their academic and personal goals by teaching them how to solve problems systematically. The investigators would like to evaluate the effectiveness of this intervention in improving students' mental health and well-being.
Read the detailed description
Half of all Ukraine war refugees are children; more than one million are in Poland, coping with multiple traumas (e.g., war, evacuation, family separation) that threaten their mental health (MH). Since meetings in Warsaw in summer 2022, PI Weisz has worked with child mental health researchers and clinicians from Ukraine and 5 other countries (the GROW consortium) and with staff of Ukrainian-language schools for displaced children to plan psychological support for the children. It is clear that Ukrainian-language digital MH interventions teaching empirically supported skills are the optimum scalable form of early psychological support, given the massive number of Ukrainian children, their dispersion to diverse countries, the dearth of professional clinicians, and the ready accessibility of digital devices. They require no professional training or funding, and are easily implemented via digital devices used in virtually all schools.
Primary child MH problems identified by research reviews and the school staff include anxiety, difficulty calming and regulating negative emotions, and diverse interpersonal and adaptation problems. The BDI, Project SOLVE helps children identify problems they can solve, and use 5 simple steps to solve them. This 30-40-minute BDI, refined via student and school staff feedback, highly rated by children, has each been accessed >750 times in the U.S. and Canada; SOLVE was found effective in a recent RCT.
Using a randomized controlled design, the investigators will test Project SOLVE with students in partner schools. Students will be randomized to receive SOLVE immediately or three months later, with students assigned to the delayed condition participating in a typical school activity instead. Using this design, the investigators can test the intervention and ensure that no student is denied access. Students will complete MH, wellbeing, and BDI-skills (i.e., mechanism of change) measures at baseline, 1-, 3-, 4-, and 6-months after baseline. Students will be randomized 50/50 to receive Project SOLVE immediately or in three months. Parents will complete parent forms of all the measures at the same time points.
- Conditions
- Trauma, Anxiety, Depression, Child Behavior
- Being tested
- Project SOLVE
- 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 SOLVEBehavioural
Project SOLVE is a ~30-minute self-guided digital intervention designed to teach children and adolescents how to set goals and solve problems systematically. Specifically, Project SOLVE is based on problem solving, a core component of cognitive behavioral therapy, a gold standard treatment for internalizing disorders. Project SOLVE uses vignettes, interactive activities, and engaging graphics to teach youth a systematic strategy for solving problems. Project SOLVE was previously found to be effective in reducing mental health symptoms among American children (https://link.springer.com/article/10.1007/s12310-023-09598-7).
| Study group | Role | What they receive |
|---|---|---|
| Project SOLVE | Experimental | Project SOLVE is a ~30-minute self-guided digital intervention designed to teach children and adolescents how to set goals and solve problems systematically. Specifically, Project SOLVE is based on problem solving, a core component of cognitive behavioral therapy, a gold standard treatment for internalizing disorders. Project SOLVE uses vignettes, interactive activities, and engaging graphics to teach youth a systematic strategy for solving problems. Project SOLVE was previously found to be effective in reducing mental health symptoms among American children (https://link.springer.com/article/10.1007/s12310-023-09598-7). Receives: Behavioral: Project SOLVE |
| Delayed Receipt of Project SOLVE Control Condition | Other | No intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition. Receives: Behavioral: Project SOLVE |
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; Students and Caregivers)
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, 3-month, 4-month, and 6-month follow-ups
Perceived Program Acceptability and Helpfulness (Students Only)
Post-intervention feedback on the program's perceived acceptability and helpfulness as measured via a 7-item scale, with each item rated on a 1-5 scale, with higher scores indicating greater acceptability and helpfulness.
Measured: Assessed immediately post-intervention
Secondary outcomes (4)
Change in Behavior and Feelings Survey (Externalizing Subscale; Students and Caregivers)
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, 3-month, 4-month, and 6-month follow-ups
Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers)
Assessed via a novel 3-item measure (0-10 scale) evaluating participants' problem-solving skills. Specific items include:
- When I have a problem with another kid, I can solve it.
- When I have a problem at home, I can solve it.
- When I have a problem at school, I can solve it
Measured: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Treatment Expectancy Questions (Students Only)
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
Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers)
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, 3-month, 4-month, and 6-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 posted3 Oct 2023
- Study start15 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 SOLVE) immediately or after three months. Participants in the delayed SOLVE condition will complete a typical school activity instead (i.e., treatment as usual). All participants will complete follow-up measures online at baseline, immediately after receiving the intervention, and 1-, 3, 4-, and 6-months after baseline.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, John Weisz, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064578
- Sponsor's protocol ID
- IRB23-0975
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytic code will be made available upon publication of trial results. Study protocol and statistical plan are available on Open Science Framework.
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
- The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth
- ClinicalTrials.gov ID
- NCT06064578
- Acronym / sponsor ID
- IRB23-0975
- Conditions
- Trauma, Anxiety, Depression, Child Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Oct 2023 (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. The investigators will be providing access to a brief online program (Project SOLVE) for students as part of the school curriculum. Ukrainian students living in Poland will be randomly assigned to receive Project SOLVE either immediately or after 3 months. The program is designed to help students manage stress and reach their academic and personal goals by teaching them how to solve problems systematically. The investigators would like to evaluate the effectiveness of this intervention in improving students' mental health and well-being.
Detailed description
Half of all Ukraine war refugees are children; more than one million are in Poland, coping with multiple traumas (e.g., war, evacuation, family separation) that threaten their mental health (MH). Since meetings in Warsaw in summer 2022, PI Weisz has worked with child mental health researchers and clinicians from Ukraine and 5 other countries (the GROW consortium) and with staff of Ukrainian-language schools for displaced children to plan psychological support for the children. It is clear that Ukrainian-language digital MH interventions teaching empirically supported skills are the optimum scalable form of early psychological support, given the massive number of Ukrainian children, their dispersion to diverse countries, the dearth of professional clinicians, and the ready accessibility of digital devices. They require no professional training or funding, and are easily implemented via digital devices used in virtually all schools.
Primary child MH problems identified by research reviews and the school staff include anxiety, difficulty calming and regulating negative emotions, and diverse interpersonal and adaptation problems. The BDI, Project SOLVE helps children identify problems they can solve, and use 5 simple steps to solve them. This 30-40-minute BDI, refined via student and school staff feedback, highly rated by children, has each been accessed >750 times in the U.S. and Canada; SOLVE was found effective in a recent RCT.
Using a randomized controlled design, the investigators will test Project SOLVE with students in partner schools. Students will be randomized to receive SOLVE immediately or three months later, with students assigned to the delayed condition participating in a typical school activity instead. Using this design, the investigators can test the intervention and ensure that no student is denied access. Students will complete MH, wellbeing, and BDI-skills (i.e., mechanism of change) measures at baseline, 1-, 3-, 4-, and 6-months after baseline. Students will be randomized 50/50 to receive Project SOLVE immediately or in three months. Parents will complete parent forms of all the measures at the same time points.
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 SOLVE) immediately or after three months. Participants in the delayed SOLVE condition will complete a typical school activity instead (i.e., treatment as usual). All participants will complete follow-up measures online at baseline, immediately after receiving the intervention, and 1-, 3, 4-, and 6-months after baseline.
| Arm | Type | Receives |
|---|---|---|
| Project SOLVE | Experimental | Behavioral: Project SOLVEProject SOLVE is a ~30-minute self-guided digital intervention designed to teach children and adolescents how to set goals and solve problems systematically. Specifically, Project SOLVE is based on problem solving, a core component of cognitive behavioral therapy, a gold standard treatment for internalizing disorders. Project SOLVE uses vignettes, interactive activities, and engaging graphics to teach youth a systematic strategy for solving problems. Project SOLVE was previously found to be effective in reducing mental health symptoms among American children (https://link.springer.com/article/10.1007/s12310-023-09598-7). |
| Delayed Receipt of Project SOLVE Control Condition | Other | Behavioral: Project SOLVENo intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Youth in grades 5+ 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 SOLVEProject SOLVE is a ~30-minute self-guided digital intervention designed to teach children and adolescents how to set goals and solve problems systematically. Specifically, Project SOLVE is based on problem solving, a core component of cognitive behavioral therapy, a gold standard treatment for internalizing disorders. Project SOLVE uses vignettes, interactive activities, and engaging graphics to teach youth a systematic strategy for solving problems. Project SOLVE was previously found to be effective in reducing mental health symptoms among American children (https://link.springer.com/article/10.1007/s12310-023-09598-7). | Behavioural | Delayed Receipt of Project SOLVE Control Condition, Project SOLVE |
Primary outcome
Change in Behavior and Feelings Survey (Internalizing Subscale; Students and Caregivers)
Time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-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 (Students Only)
Time frame: Assessed immediately post-intervention
Post-intervention feedback on the program's perceived acceptability and helpfulness as measured via a 7-item scale, with each item rated on a 1-5 scale, with higher scores indicating greater acceptability and helpfulness.
4 secondary outcomes
Change in Behavior and Feelings Survey (Externalizing Subscale; Students and Caregivers)
Time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers)
Time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Treatment Expectancy Questions (Students Only)
Time frame: Assessed immediately pre-intervention
Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers)
Time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-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.
- Individual participant dataSharing planned: Yes. 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 SOLVE 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; Students and Caregivers) (time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-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?
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.