Optimizing a School-Based Therapeutic Play Intervention for Preschool Students

Optimizing a School-Based Therapeutic Play Intervention for Preschool Students: A Factorial Experiment Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Socioemotional Development
• Intervention / Treatment: Behavioral: Individual play sessions; Behavioral: Peer play sessions; Behavioral: Classroom push-in sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erinn B Duprey, Ph.D.; Phone Number: (585) 295-1000; Email: eduprey@childrensinstitute.net

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14604
      • Recruiting
      • Children's Institute
      • Contact: Erinn B Duprey, Ph.D.; Phone Number: (585) 295-1000; Email: eduprey@childrensinstitute.net
      • Contact: Joseph McFall, Ph.D.; Email: jmcfall@childrensinstitute.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pre-intervention and post-intervention (within 1 week)
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.	Pre- and post-intervention (within 1 week)
Emotion Regulation	Parents will complete the Emotion Regulation Checklist (ERC), which assesses children's regulatory skills and emotional lability (Shields & Cicchetti, 1997).	Pre- and post-intervention (within 1 week)

Collaborators and Investigators

• Sponsor: The Children's Institute

Publications and helpful links

General Publications

• Guastaferro K, Collins LM. Achieving the Goals of Translational Science in Public Health Intervention Research: The Multiphase Optimization Strategy (MOST). Am J Public Health. 2019 Feb;109(S2):S128-S129. doi: 10.2105/AJPH.2018.304874. No abstract available.
• National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/
• Shields A, Cicchetti D. Emotion regulation among school-age children: the development and validation of a new criterion Q-sort scale. Dev Psychol. 1997 Nov;33(6):906-16. doi: 10.1037//0012-1649.33.6.906.
• Perou R, Bitsko RH, Blumberg SJ, Pastor P, Ghandour RM, Gfroerer JC, Hedden SL, Crosby AE, Visser SN, Schieve LA, Parks SE, Hall JE, Brody D, Simile CM, Thompson WW, Baio J, Avenevoli S, Kogan MD, Huang LN; Centers for Disease Control and Prevention (CDC). Mental health surveillance among children--United States, 2005-2011. MMWR Suppl. 2013 May 17;62(2):1-35.
• Greenberg MT, Weissberg RP, O'Brien MU, Zins JE, Fredericks L, Resnik H, Elias MJ. Enhancing school-based prevention and youth development through coordinated social, emotional, and academic learning. Am Psychol. 2003 Jun-Jul;58(6-7):466-74. doi: 10.1037/0003-066x.58.6-7.466.
• Little RJ. Missing Data Analysis. Annu Rev Clin Psychol. 2024 Jul;20(1):149-173. doi: 10.1146/annurev-clinpsy-080822-051727. Epub 2024 Jul 2.
• Baraldi AN, Enders CK. An introduction to modern missing data analyses. J Sch Psychol. 2010 Feb;48(1):5-37. doi: 10.1016/j.jsp.2009.10.001.
• Marik PE, Hooper MH. Adjuvant Vitamin C in critically ill patients undergoing renal replacement therapy: What's the right dose? Crit Care. 2018 Nov 22;22(1):320. doi: 10.1186/s13054-018-2190-y. No abstract available.
• Gongye R, Duprey EB, Hightower AD, McFall JP. Measuring adverse and protective experiences in early childhood: development and initial validation of the child and family experiences survey (CAFES). BMC Public Health. 2025 Oct 24;25(1):3590. doi: 10.1186/s12889-025-24881-9.
• Gilbertson TJ, Morgan AJ, Rapee RM, Lyneham HJ, Bayer JK. Psychometric properties of the Child Anxiety Life Interference Scale - Preschool Version. J Anxiety Disord. 2017 Dec;52:62-71. doi: 10.1016/j.janxdis.2017.10.002. Epub 2017 Oct 13.
• Collins LM, Strayhorn JC, Vanness DJ. One view of the next decade of research on behavioral and biobehavioral approaches to cancer prevention and control: intervention optimization. Transl Behav Med. 2021 Nov 30;11(11):1998-2008. doi: 10.1093/tbm/ibab087.
• Collins LM, Nahum-Shani I, Guastaferro K, Strayhorn JC, Vanness DJ, Murphy SA. Intervention Optimization: A Paradigm Shift and Its Potential Implications for Clinical Psychology. Annu Rev Clin Psychol. 2024 Jul;20(1):21-47. doi: 10.1146/annurev-clinpsy-080822-051119. Epub 2024 Jul 2.
• Guastaferro K, Pfammatter AF. Guidance on selecting a translational framework for intervention development: Optimizing interventions for impact. J Clin Transl Sci. 2023 May 11;7(1):e119. doi: 10.1017/cts.2023.546. eCollection 2023.
• Johnson DB, Pedro-Carroll JL, Demanchick SP. The Primary Mental Health Project: A Play Intervention for School-Age Children. 2005.
• Peabody MA, Perryman KL, Hannah M, Smith L, Sanyshyn SM. Improving Mental Health Outcomes for Young Children through the Implementation of the Primary Project. Journal of School-Based Counseling Policy and Evaluation. 2018;1(1):40-50.
• Perryman KL, Bowers L. Turning the focus to behavioral, emotional, and social well-being: The impact of child-centered play therapy. International Journal of Play Therapy. 2018;27(4):227-41. doi:10.1037/pla0000078
• Ray DC, Armstrong SA, Balkin RS, Jayne KM. Child-centered play therapy in the schools: Review and meta-analysis. Psychol Sch. 2015 Feb 1;52(2):107-23. doi:10.1002/pits.21798
• Aviles AM, Anderson TR, Davila ER. Child and Adolescent Social-Emotional Development Within the Context of School. Child Adolesc Ment Health. 2006 Feb;11(1):32-39. doi: 10.1111/j.1475-3588.2005.00365.x.
• Mulraney M, Coghill D, Bishop C, Mehmed Y, Sciberras E, Sawyer M, Efron D, Hiscock H. A systematic review of the persistence of childhood mental health problems into adulthood. Neurosci Biobehav Rev. 2021 Oct;129:182-205. doi: 10.1016/j.neubiorev.2021.07.030. Epub 2021 Aug 4.
• Alzahrani M, Alharbi M, Alodwani A. The Effect of Social-Emotional Competence on Children Academic Achievement and Behavioral Development. International Education Studies. 2019 Nov 29;12(12):141. doi:10.5539/ies.v12n12p141
• Greenberg MT, Domitrovich CE, Weissberg RP, Durlak JA. Social and emotional learning as a public health approach to education. Future of Children. 2017;27(1):13-32. doi:10.1353/foc.2017.0001
• Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2021 National Survey on Drug Use and Health (HHS Publication No. PEP22-07-01-005, NSDUH Series H-57). 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Early childhood; Preschool; Play therapy; Multiphase optimization strategy; Factorial trial; Social emotional learning
• Other Study ID Numbers: 1376935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The study will protect the confidentiality of all data at all stages. Parents are informed during the consent process that all responses are confidential and are only for research purposes.

Only the investigator and authorized study personnel will have access to identifiable information. Data is stored on password-protected servers compliant with FERPA and all personal identifiers will be removed prior to analysis. Each participant will be assigned an anonymized study identifier.After data collection is complete, only deidentified data will be retained for analysis and long-term storage. These deidentified datasets will be stored on encrypted cloud-based servers with access restricted to the study team.

Data will be reported on in the aggregate, and we will not report on any subgroups with fewer than 10 individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No