Optimizing a School-Based Therapeutic Play Intervention for Preschool Students (NCT07609342) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing a School-Based Therapeutic Play Intervention for Preschool Students
United States225 participantsStarted 2024-10-18
Plain-language summary
The goal of this clinical trial is to optimize a school-based therapeutic play intervention in preschool students with mild to moderate school adjustment difficulties. The aims are:
1. Determine the independent and combined effects of three intervention components (individual play, peer play, and classroom push-in sessions) on preschool children's social and emotional competence, using a factorial experimental design.
2. Use a community-engaged approach to identify and disseminate the optimized version of Primary Project for preschool implementation
Researchers will compare the main and interactive effects of three components on children's social-emotional competencies.
Participants will take part in a therapeutic play intervention in the school setting, and their teachers and caregivers will complete assessment instruments on children's social and emotional functioning.
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Children will be eligible if they are enrolled in preschool classrooms at participating schools and identified as appropriate for intervention through universal screening. Screening will be conducted using the Teacher-Child Rating Scale (T-CRS; Hightower et al., 1986), a teacher-completed measure of social-emotional adjustment. Children who score in the target range indicating emerging adjustment difficulties (i.e., 15th to 30th percentile) will be eligible for participation in the trial.
Exclusion Criteria: Children will be excluded if they demonstrate severe developmental impairments that would prevent participation in the intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Social-emotional adjustment
Timeframe: Teachers will complete the T-CRS prior to study enrollment and randomization, and will complete a second T-CRS form for participants within 2 weeks of intervention completion.