Optimizing a School-Based Therapeutic Play Intervention for Preschool Students

NCT07609342 | Recruiting

• 1 other identifier: 1376935
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Use a community-engaged approach to identify and disseminate the optimized version of Primary Project for preschool implementation

Conditions

Socioemotional Development

Keywords

Factorial trial; Social emotional learning; Multiphase optimization strategy; Preschool; Early childhood; Play therapy

Outcome Measures

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.

  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 (3)

• School connectedness

  Pre-intervention and post-intervention (within 1 week)

• School anxiety

  Pre- and post-intervention (within 1 week)

• Emotion Regulation

  Pre- and post-intervention (within 1 week)

Study Arms (8)

Condition 1

EXPERIMENTAL

Individual play sessions (8 weeks), Peer play pairs, Classroom sessions

Behavioral: Individual play sessions; Behavioral: Peer play sessions; Behavioral: Classroom push-in sessions

Condition 2

EXPERIMENTAL

Individual play sessions (8 weeks), Peer play pairs

Behavioral: Individual play sessions; Behavioral: Peer play sessions

Condition 3

EXPERIMENTAL

Individual play sessions (8 weeks), Classroom sessions

Behavioral: Individual play sessions; Behavioral: Classroom push-in sessions

Condition 4

EXPERIMENTAL

Individual play sessions (8 weeks)

Behavioral: Individual play sessions

Condition 5

EXPERIMENTAL

Individual play sessions (12 weeks), Peer play pairs, Classroom sessions

Behavioral: Individual play sessions; Behavioral: Peer play sessions; Behavioral: Classroom push-in sessions

Condition 6

EXPERIMENTAL

Individual play sessions (12 weeks), Peer play pairs

Behavioral: Individual play sessions; Behavioral: Peer play sessions

Condition 7

EXPERIMENTAL

Individual play sessions (12 weeks), Classroom sessions

Behavioral: Individual play sessions; Behavioral: Classroom push-in sessions

Condition 8

EXPERIMENTAL

Individual play sessions (12 weeks)

Behavioral: Individual play sessions

Interventions

Individual play sessions BEHAVIORAL

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.

Condition 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Peer play sessions BEHAVIORAL

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

Condition 1; Condition 2; Condition 5; Condition 6

Classroom push-in sessions BEHAVIORAL

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.

Condition 1; Condition 3; Condition 5; Condition 7

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• The Children's Institute: lead

Study Sites (1)

Children's Institute

Rochester, New York, 14604, United States

RECRUITING

Related Publications (22)

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  BACKGROUND

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  BACKGROUND

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Central Study Contacts

Erinn B Duprey, Ph.D.

CONTACT

(585) 295-1000; eduprey@childrensinstitute.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 27, 2026
• Study Start: October 18, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)