Guidance on selecting a translational framework for intervention development: Optimizing interventions for impact.
Kate Guastaferro, Angela F Pfammatter
https://pubmed.ncbi.nlm.nih.gov/37313386/Actively Recruiting
Led by The Children's Institute · Updated on 2026-05-27
225
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are evaluating a school-based therapeutic play intervention designed to improve social and emotional skills in preschool children with mild to moderate difficulties adjusting to school. This trial aims to understand how three different components of the interventionindividual play sessions, peer play sessions, and classroom push-in sessionsindependently and together affect childrens social and emotional competence. The study uses a factorial experimental design to optimize this intervention for preschool settings, focusing on feasibility and effectiveness. Participants will be randomly assigned to receive varied combinations of the three intervention components, including individual play sessions lasting 8 or 12 weeks, peer play pairs involving six biweekly sessions, and classroom push-in sessions with four biweekly visits. Individual play sessions are conducted twice weekly in a playroom using child-centered play therapy principles. Peer play sessions pair children with socially competent peers to practice cooperation and communication skills, while classroom push-ins support engagement and positive peer interactions within regular classroom activities. During the study, teachers and caregivers will complete assessments rating childrens social and emotional adjustment before and after the intervention. Outcomes such as social-emotional adjustment, school connectedness, school anxiety, and emotion regulation will be measured using standardized tools. The study aims to identify which intervention combinations best support childrens development and to create an optimized program for wider use. Participation includes regular play sessions at school over several weeks and completing assessment forms within specified timeframes.
CONDITIONS
Optimizing a School-Based Therapeutic Play Intervention for Preschool Students
E
Erinn B Duprey, Ph.D.
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The Children's Institute
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Randomized Play-Based Intervention Combinations | Current School-Wide Social-Emotional Learning |
|---|---|---|
| What it is | Randomized combinations of child-centered therapeutic play interventions, including individual sessions (8 or 12), peer play sessions, and classroom push-ins, each designed to support preschoolers with emerging social-emotional adjustment difficulties. | A whole-school coordinated social-emotional learning (SEL) program, typically delivered to all students as a universal preventive and developmental approach to support social-emotional skills and adjustment in preschool-aged children. |
| Role in the trial | Intervention combinations under investigation for optimizing the impact of therapeutic play on social-emotional functioning in preschool children at risk, delivered to all children assigned to the study through the randomization process. | Not included as a randomized arm in this trial. Represents the standard prevention and support approach currently adopted in most preschool settings outside the study. |
| Primary use | Used as a targeted intervention for preschoolers at risk for social-emotional adjustment problems, aiming to strengthen social competence, peer relations, and emotion regulation through structured play. | Delivered as a universal preventive curriculum across all students to promote positive behavioral, social, and emotional skills and to prevent adjustment difficulties in early learning environments. |
| How it is given or performed | Children receive a mix of individual and peer play sessions (in a designated playroom) and/or classroom push-in sessions, each delivered by trained child associates during the school day. The format and session count vary by assignment: 8 or 12 sessions, and/or peer/classroom components. | Implemented school-wide by classroom teachers and staff, often integrated into regular classroom activities using SEL curriculum materials and activities, with consistent routines and explicit instruction. |
| Evidence status | Currently investigational; the efficacy of specific play-based intervention combinations for improving preschool social-emotional functioning is still being evaluated. No trial outcome results have been published yet. | Strongly supported by guideline and review evidence, with research showing school-wide SEL curricula can improve social skills, emotional regulation, and adjustment, and reduce behavioral problems in early childhood settings. |
| Important limitations | Effectiveness of intervention combinations has not yet been established; generalizability may be limited to similar populations and settings. Trial does not compare to an active universal SEL curriculum arm, and relies on teacher-rated outcomes. | SEL program effectiveness may vary by curriculum quality, fidelity of implementation, and classroom or school context; some children with higher needs may require more individualized or intensive support than universal delivery provides. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 12 weeks
Participants receive individual play sessions, and may also participate in peer play sessions and classroom push-in sessions depending on their group assignment. These sessions aim to improve social-emotional adjustment through child-centered play interventions in preschool settings.
Twice weekly individual play sessions; up to six biweekly peer play sessions; up to four biweekly classroom push-in sessions
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
8
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Lead Sponsor