Optimizing a School-Based Therapeutic Play Intervention for Preschool Students

BEHAVIORAL

Individual play sessions

All children will receive individual play sessions with a child associate in a designated playroom within the school. Sessions will last 20-30 minutes and occur twice per week. All sessions are grounded in child-centered play therapy (CCPT) principles. Child associates use a non-directive approach, allowing children to choose from a range of developmentally appropriate toys and play materials (e.g., art supplies, blocks, puppets, and imaginative play sets) that encourage expression, problem-solving, and emotional regulation. The role of the child associate is to create a safe and supportive environment, verbally reflect on children's actions and feelings, and facilitate their self-directed play in ways that promote social and emotional growth. In the factorial design, children will be randomized to receive either 8 or 12 individual play sessions.

BEHAVIORAL

Peer play sessions

Children randomized to this condition will participate in structured play pairs, consisting of six, biweekly, 30-minute sessions with a peer and the child associate. Peers are non-study children who exhibit excellent social and emotional competencies, as observed and rated by their teachers during universal screening. Pairings will be determined collaboratively with teachers to ensure compatibility and opportunities for skill-building. Parents of play pairs give permission for their child to participate in regular Primary Project implementation. The sessions will be designed to promote social competence, cooperation, and peer connectedness by providing guided opportunities to practice skills such as sharing, turn-taking, communication, and conflict resolution. While maintaining a child-directed approach, the child associate will actively scaffold interactions by reflecting and reinforcing positive peer behaviors, providing gentle redirection when difficulties arise, and offering a vari

BEHAVIORAL

Classroom push-in sessions

Children randomized to this condition will receive four, bi-weekly, classroom push-in sessions facilitated by the child associate. Push-in sessions will be scheduled weekly during regular classroom activities (e.g., circle time, free play, or small-group learning). During classroom push-in times, the child associate uses child-led therapeutic play techniques to help foster classroom engagement, positive peer interaction, and a sense of belonging for the target child. Child associates will coordinate with classroom teachers to integrate push-ins smoothly and to reinforce skills across settings.

Social-emotional adjustment

Time frame: 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.

The primary outcome is children's social-emotional adjustment, assessed using teacher reports on the Teacher-Child Rating Scale, short-form (T-CRS-sf; Weber et al., 2017). The key analysis metric will be change in T-CRS scores from baseline (pre-intervention) to post-intervention.

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.