Depression Clinical Trial
Official title:
The Ukrainian Student Problem Solving Project: A Randomized Effectiveness Trial of a Brief, Digital Problem Solving Intervention for Youth
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.
Status | Recruiting |
Enrollment | 1765 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 5, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Harvard University | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard University | King's College London |
United States,
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 |
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