The Ukrainian Student Problem Solving Project

Depression Clinical Trial

Official title:

The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064578
• Other study ID #: IRB23-0975
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: November 2023
• Source: Harvard University
• Contact: John R Weisz, PhD
• Phone: 617-877-7716
• Email: john_weisz[@]harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1765
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Child Behavior
• Depression
• Trauma

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University	King's College London

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Primary	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.	Assessed immediately post-intervention
Secondary	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.	Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Secondary	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	Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Secondary	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.	Assessed immediately pre-intervention
Secondary	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).	Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups