An interventional study of Project SOLVE in Trauma, Anxiety and Depression, sponsored by Harvard University. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Harvard University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 778 is above the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
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
No intervention for first three months; will receive SOLVE after 3-months and become a second-wave intervention condition.
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).
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.
Time frame: 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.
Time frame: Assessed immediately post-intervention
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.
Time frame: 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 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
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.
Time frame: Assessed immediately pre-intervention
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).
Time frame: Assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups
Plan to share: Yes — Analytic code will be made available upon publication of trial results. Study protocol and statistical plan are available on Open Science Framework.
Supporting information: Analytic code
Time frame: To be shared on OSF once data collection and analyses are complete.
Data sharing details ↗ · osf.io
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Jun 2024, 8 months.
Of 1,289 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's 8 months is below that.
Counting every sponsor, half of 1,394 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Harvard University