Optimizing a School-Based Therapeutic Play Intervention for Preschool Students

Part of paid clinical trials in Rochester, New York.

Sponsor
The Children's Institute
Study ID
NCT07609342
Status
Recruiting

Conditions

  • Socioemotional Development

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Not accepted

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.
  • 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
  • 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.

Study Details

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.

Key Dates

Start date
Oct 18, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's InstituteRochesterNew York14604
Erinn B Duprey, Ph.D.
(585) 295-1000
Joseph McFall, Ph.D.

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