NCT07609342 · The Children's Institute
Optimizing a School-Based Therapeutic Play Intervention for Preschool Students
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations