- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06064578
The Ukrainian Student Problem Solving Project
The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joshua S Steinberg, BA
- Phone Number: 617-945-3115
- Email: joshuasteinberg@g.harvard.edu
Study Contact Backup
- Name: John R Weisz, PhD
- Phone Number: 617-877-7716
- Email: john_weisz@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 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
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 SOLVE
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).
|
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).
|
Other: Delayed Receipt of Project SOLVE Control Condition
No intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
|
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.
|
Assessed immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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, 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
|
Assessed via a novel 3-item measure (0-10 scale) evaluating participants' problem-solving skills. Specific items include:
|
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
|
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
|
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
|
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, 3-month, 4-month, and 6-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
- IRB23-0975
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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