Clinical trial NCT06064578: The Ukrainian Student Problem Solving Project
Official title: The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Anxiety
Depression
Child Behavior
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-10-03
Enrollment: 778
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Behavior and Feelings Survey (Internalizing Subscale; Students and Caregivers)
timeFrame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
measure: Perceived Program Acceptability and Helpfulness (Students Only)
timeFrame: Assessed immediately post-intervention
Secondary outcomes:
measure: Change in Behavior and Feelings Survey (Externalizing Subscale; Students and Caregivers)
timeFrame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
measure: Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers)
timeFrame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
measure: Treatment Expectancy Questions (Students Only)
timeFrame: Assessed immediately pre-intervention
measure: Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers)
timeFrame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
References: