Purpose

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.

Condition

Eligibility

Eligible Ages
Between 3 Years and 6 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Condition 1
Individual play sessions (8 weeks), Peer play pairs, Classroom sessions
  • 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.
Experimental
Condition 2
Individual play sessions (8 weeks), Peer play pairs
  • 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
Experimental
Condition 3
Individual play sessions (8 weeks), Classroom sessions
  • 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: 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.
Experimental
Condition 4
Individual play sessions (8 weeks)
  • 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.
Experimental
Condition 5
Individual play sessions (12 weeks), Peer play pairs, Classroom sessions
  • 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.
Experimental
Condition 6
Individual play sessions (12 weeks), Peer play pairs
  • 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
Experimental
Condition 7
Individual play sessions (12 weeks), Classroom sessions
  • 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: 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.
Experimental
Condition 8
Individual play sessions (12 weeks)
  • 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.

Recruiting Locations

Children's Institute
Rochester, New York 14604
Contact:
Erinn B Duprey, Ph.D.
(585) 295-1000
eduprey@childrensinstitute.net

More Details

Status
Recruiting
Sponsor
The Children's Institute

Study Contact

Erinn B Duprey, Ph.D.
(585) 295-1000
eduprey@childrensinstitute.net

Detailed Description

Background and rationale: There are a growing number of children in the United States with mental, emotional, or behavioral health concerns (Perou et al., 2013; SAMHSA, 2022). Left untreated, these difficulties may persist through development and contribute to a wide range of negative outcomes in adolescence and adulthood. Consequently, there is a critical need to identify effective strategies that promote protective factors, enhance resiliency, and disrupt the causal processes that facilitate the emergence of subsequent mental health problems. Prevention programs that enhance young children's social and emotional competencies can both alleviate present difficulties and protect youth against future mental health problems (Greenberg et al., 2003; Greenberg et al., 2017). Early childhood is a critical developmental period for social and emotional growth, with key developmental milestones including the growth of peer social skills and self-regulation abilities. Educational settings are important contexts for fostering young children's social and emotional development. Children who adjust well to the school setting are more apt to thrive in terms of their social and emotional skill development, whereas children who struggle with the transition to the early school years may face challenges across multiple domains (Alzahrani et al., 2019). It is these elevated symptoms detected within the general student population, not diagnoses of specific childhood disorders, that best predict adult mental health outcomes (Mulraney et al., 2021). Consequently, preventive interventions that include universal screening and encourage social and emotional skill development, while also facilitating a positive transition to the educational environment, are ideal. School-based interventions are well positioned to strengthen children's social and emotional competencies and reduce future risk (National Research Council & Institute of Medicine, 2009). Schools serve as a context for growth in multiple domains of socioemotional development, including interpersonal skill development with peers and adult figures, intrapersonal awareness of academic and non-academic skills, coping with difficulties, and managing the simultaneous demands of curricular and extracurricular activities (Aviles et al., 2006). Further, recent evidence indicates that school-based interventions grounded in child-centered play therapy (CCPT) are related to reductions in children's behavioral, emotional, and academic problems (Ray et al., 2015). There is also some growing evidence that non-clinical preventive interventions grounded in the tenets of CCPT (i.e., Child-Centered Play Interventions; CCPIs) are effective for children's social and emotional development (Perryman & Bowers, 2018). CCPIs are often more feasible and sustainable for schools - for instance, they are facilitated by a specially trained school-based paraprofessional (i.e., child associate) who is supervised by a licensed school-based mental health professional (Peabody et al., 2018). However, research based on CCPIs is limited. Primary Project is a long-standing CCPI that targets children in kindergarten through third grade (approximately ages 5 - 9) who are having school adjustment difficulties (Johnson et al., 2005; Peabody et al., 2018). The program provides structured play sessions with trained paraprofessional child associates under the supervision of mental health professionals to support children with early school adjustment difficulties. The goals of Primary Project are to enhance school-related social and emotional competencies (e.g., task orientation and peer social skills) while reducing behavioral and interpersonal adjustment difficulties in children. Prior research has established the effectiveness of Primary Project in improving school adjustment outcomes in young children (see Cowen et al., 1996 for a review) and a recent study demonstrated positive effects on children's school attendance (Lotyczewski et al., 2024). A recent randomized controlled trial supported the program's effectiveness for improving children's social skills and self-regulation (Aaron et al., forthcoming). Building on this foundation, Primary Project was adapted for preschool-aged children (approximately age 4) by adding developmentally appropriate components, including a greater focus on peer-play skills. The Pre-K Primary Project model includes three core components: individual play sessions, structured peer play sessions, and classroom push-in sessions wherein the paraprofessional child associate provides individual support to the child in a classroom setting. Conceptually, these three components act upon proximal mediators (e.g., increasing emotion regulation skills and self-efficacy; facilitating positive peer relationships; and promoting school connectedness) to enhance children's overall social-emotional adjustment (Figure 1). However, despite increasing implementation, the Pre-K Primary Project model has not undergone systematic evaluation to understand which components, and in what combination, are most effective. This represents a critical gap given the Pre-K model's multi-component nature. Understanding the individual and combined effects of its components is essential to guide schools towards efficient and sustainable program goals. The current trial addresses this gap by using the Multiphase Optimization Strategy (MOST), an innovative translational framework (Guastaferro & Pfammatter, 2023) to develop and evaluate multi-component interventions (Collins et al., 2024; Guastaferro & Collins, 2019). MOST involves three phases: preparation, optimization, and evaluation. In the preparation phase, investigators establish a conceptual model, identify candidate intervention components, and define an optimization objective that balances effectiveness with practical constraints. In the optimization phase, the goal is to empirically identify the optimized intervention via a randomized controlled trial (RCT), often using a factorial experimental design. The optimized intervention is the combination of candidate intervention components that achieves the best balance of intervention effectiveness with affordability, scalability, and efficiency (i.e., intervention EASE; Collins et al., 2021) Finally, in the evaluation phase, the optimized intervention package is tested in a RCT, usually in a 2-arm trial, to confirm its effectiveness under real-world conditions compared to a suitable control. The present trial represents the optimization phase of MOST. The specific optimization goal is to identify the combination of components that are most effective for improving children's social-emotional outcomes and school adjustment, while also being feasible in terms of program timing and resource constraints (e.g., ability to offer two full cycles per school year without incurring additional staffing costs). In sum, this trial examines whether individual play sessions, peer play sessions, and classroom push-ins, independently and in combination, improve preschool children's social-emotional adjustment. The overall goal is to develop an optimized program model for broader dissemination. Objectives: The primary objective of this trial is to optimize the Pre-K Primary Project intervention for strengthening preschool children's social-emotional adjustment. The first specific aim of this study is to 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. As an exploratory sub-aim, we also seek to explore the impact of intervention components on identified mediators including children's level of school connectedness, emotion regulation, and peer relationships. These exploratory analyses will inform iterative revisions to the conceptual model and future research studies. Our second specific aim is to use a community-engaged approach to identify and disseminate the optimized version of Primary Project for preschool implementation. Specifically, we will work with school partners to consider the results from the optimization trial, balanced with the feasibility, sustainability, and affordability of different intervention packages (e.g., ability to offer two cycles per school year without incurring additional costs from staffing or other resources). These results will be disseminated via a new program manual and other materials targeted to both academic and non-academic audiences.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.