The Ukrainian Student Problem Solving Project

NCT06064578 | Completed

• 1 other identifier: IRB23-0975
• Study Type: interventional
• Target: 778
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Anxiety; Depression; Child Behavior

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change in Behavior and Feelings Survey (Externalizing Subscale; Students and Caregivers)

  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 at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups

• Treatment Expectancy Questions (Students Only)

  Assessed immediately pre-intervention

• Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers)

  Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups

Study Arms (2)

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).

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.

Behavioral: Project SOLVE

Interventions

Project SOLVE BEHAVIORAL

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).

Delayed Receipt of Project SOLVE Control Condition; Project SOLVE

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Youth does not have access to a digital device
• Youth has an intellectual disability that precludes comprehension of the program content

Sponsors & Collaborators

• Harvard University: lead
• King's College London: collaborator

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Anxiety Disorders; Depression; Child Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be completed independently by participants online. Investigators will be blinded to condition throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: October 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: To be shared on OSF once data collection and analyses are complete.

Locations

US (1)