Optimizing a School-Based Therapeutic Play Intervention for Preschool Students
ConditionSocioemotional Development
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorThe Children's Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
Individual play sessions
BehavioralAll 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.
Peer play sessions
BehavioralChildren 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
Classroom push-in sessions
BehavioralChildren 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.
Treatment groups
225 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Condition 1Experimental treatment 3 interventions
Group B: Condition 2Experimental treatment 2 interventions
Group C: Condition 3Experimental treatment 2 interventions
Group D: Condition 4Experimental treatment 1 intervention
Group E: Condition 5Experimental treatment 3 interventions
Group F: Condition 6Experimental treatment 2 interventions
Group G: Condition 7Experimental treatment 2 interventions
Group H: Condition 8Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Social-emotional adjustment
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.
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.Secondary outcomes
1
School connectedness
School connectedness will be assessed through a pilot Preschool School Connectedness Measure, a parent reported measure developed by researchers at Children's Institute, which captures children's sense of belonging and connectedness at school
Time frame
Pre-intervention and post-intervention (within 1 week)2
School anxiety
Parents will complete the Child Anxiety Life Interference Scale (Preschool Version), a validated parent-reported scale assessing children's anxiety symptoms related to school contexts.
Time frame
Pre- and post-intervention (within 1 week)3
Emotion Regulation
Parents will complete the Emotion Regulation Checklist (ERC), which assesses children's regulatory skills and emotional lability (Shields \& Cicchetti, 1997).
Time frame
Pre- and post-intervention (within 1 week)Sponsors and contacts
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Source ClinicalTrials.gov