search
Back to results

The Ukrainian Student Problem Solving Project

Primary Purpose

Trauma, Anxiety, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Project SOLVE
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Project SOLVE

    Delayed Receipt of Project SOLVE Control Condition

    Arm Description

    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).

    No intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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
    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.
    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).

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Harvard University
    Collaborators
    King's College London
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06064578
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    April 15, 2024 (Anticipated)
    Study Completion Date
    April 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard University
    Collaborators
    King's College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trauma, Anxiety, Depression, Child Behavior

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    InvestigatorOutcomes Assessor
    Masking Description
    Assessments will be completed independently by participants online. Investigators will be blinded to condition throughout the study.
    Allocation
    Randomized
    Enrollment
    1765 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Project SOLVE
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Delayed Receipt of Project SOLVE Control Condition
    Arm Type
    Other
    Arm Description
    No intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Project SOLVE
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change in Behavior and Feelings Survey (Internalizing Subscale; Students and Caregivers)
    Description
    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.
    Time Frame
    Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
    Title
    Perceived Program Acceptability and Helpfulness (Students Only)
    Description
    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.
    Time Frame
    Assessed immediately post-intervention
    Secondary Outcome Measure Information:
    Title
    Change in Behavior and Feelings Survey (Externalizing Subscale; Students and Caregivers)
    Description
    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.
    Time Frame
    Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
    Title
    Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers)
    Description
    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
    Time Frame
    Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
    Title
    Treatment Expectancy Questions (Students Only)
    Description
    Treatment expectations will be assessed at pre-intervention via a novel 4-item measure (0-10 scale) evaluating participants' expectations of intervention effects.
    Time Frame
    Assessed immediately pre-intervention
    Title
    Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers)
    Description
    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).
    Time Frame
    Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John R Weisz, PhD
    Phone
    617-877-7716
    Email
    john_weisz@harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joshua S Steinberg, BA
    Phone
    617-945-3115
    Email
    joshuasteinberg@g.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Analytic code will be made available upon publication of trial results. Study protocol and statistical plan are available on Open Science Framework.
    IPD Sharing Time Frame
    To be shared on OSF once data collection and analyses are complete.
    IPD Sharing URL
    https://osf.io/u495j

    Learn more about this trial

    The Ukrainian Student Problem Solving Project

    We'll reach out to this number within 24 hrs