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Behavioral Intervention

Online Problem Solving Program for Mental Health Improvement

N/A

Recruiting

Research Sponsored by Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test if a brief online program can improve mental health, functioning, and wellbeing of Ukrainian students in Poland. Participants will receive the program immediately or after 3 months.

Who is the study for?

This trial is for Ukrainian students in Poland, grades 5 and up, who can read Ukrainian well enough to use digital programs. They must have consent from a guardian and access to a digital device. The study aims to help them with stress management and problem-solving skills.Check my eligibility

What is being tested?

Project SOLVE, an online single-session program designed as part of the school curriculum, is being tested for its effectiveness on youth mental health and well-being. Students are randomly chosen to either start immediately or after three months.See study design

What are the potential side effects?

Since Project SOLVE is a non-medical intervention focusing on education and skill development through an online platform, it does not have typical medical side effects; however, there may be varying psychological impacts based on individual student experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 1-month, 3-month, 4-month, and 6-month follow-ups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Perceived Program Acceptability and Helpfulness (Students Only)

Secondary outcome measures

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

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

Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Project SOLVEExperimental Treatment1 Intervention

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).

Group II: Delayed Receipt of Project SOLVE Control ConditionExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Project SOLVE

2021

N/A

~530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Harvard UniversityLead Sponsor

230 Previous Clinical Trials

472,860 Total Patients Enrolled

26 Trials studying Depression

8,153 Patients Enrolled for Depression

King's College LondonOTHER

722 Previous Clinical Trials

25,754,891 Total Patients Enrolled

43 Trials studying Depression

24,112 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants of a younger age bracket?

"This medical experiment is accepting subjects aged between 10 and 18, inclusive."

Answered by AI

Are there any opportunities to participate in this research study?

"Clinicaltrials.gov confirms that this clinical trial is actively seeking patients; the original post was made on October 15th 2023 and has been revised as recently as November 16th 2023."

Answered by AI

Would I be eligible to participate in this research endeavor?

"This research seeks 1765 juveniles with anxiety aged between 10 and 18 who meet the following requirements: enrolment in a Ukrainian elementary school, legal consent from both participant and guardian, fluency in Ukrainian sufficient to complete digital tasks, access to an electronic device."

Answered by AI

How many participants are participating in the research study?

"Affirmative. Per the details on clinicaltrials.gov, this trial is in search of potential participants. It was first posted on October 15th 2023 and has been revised as recently as November 16th 2023. A total of 1765 individuals need to be registered from a single site."

Answered by AI

What are the overarching aims of this medical research experiment?

"The primary outcome for this trial, measured at the outset of intervention, is Change in Behavior and Feelings Survey (Internalizing Subscale; Students and Caregivers). Secondary end-points include Student Problem-Solving Mechanisms of Change Questions (Students and Caregivers), a 3-item measure on a 0 to 10 scale that assesses participants' problem solving abilities. Additionally, Treatment Expectancy Questions (Students Only) will be used to gauge treatment expectations with 4 items ranked from 0 to 10 scores. Lastly, Peabody Treatment Progress Battery's Life Satisfaction Scale (Students and Caregivers) evaluates overall life satisfaction through"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Ukrainian Student Problem Solving Project

John Weisz 2023. "The Ukrainian Student Problem Solving Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064578.