Early Childhood Friendship Project for Healthy Preschoolers
(ECFP-3 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the Early Childhood Friendship Project treatment?
How is the Early Childhood Friendship Project treatment different from other treatments for preschoolers?
The Early Childhood Friendship Project is unique because it focuses on fostering social skills and friendships among preschoolers, which is not typically the primary focus of other treatments that often emphasize physical health or academic readiness. This approach aims to improve social development and peer interactions, which can have long-term benefits for children's emotional and social well-being.678910
What is the purpose of this trial?
The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms.
Research Team
Jamie M Ostrov, Ph.D.
Principal Investigator
University at Buffalo, SUNY
Eligibility Criteria
This trial is for children attending certain child care centers in the Buffalo region of New York who are planning to start kindergarten in the fall. There are no specific exclusion criteria, so it appears open to all eligible children at these centers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the Early Childhood Friendship Project intervention, including puppet shows, motor activities, and behavioral reinforcement
Follow-up
Participants are monitored for changes in aggression, prosocial behavior, and academic competence
Extended Follow-up
Long-term monitoring of intervention effects on school readiness and transition to kindergarten
Treatment Details
Interventions
- Early Childhood Friendship Project
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator