NCT05908461 The Early Childhood Friendship Project - Phase 3
| NCT ID | NCT05908461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2027-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2023-08-16 with a primary completion date of 2027-04-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * A child is eligible if attending one of the participating child care centers in the greater Buffalo region of Western New York and planning to enter kindergarten in the fall. Exclusion Criteria: * None
Contact & Investigator
Jamie M Ostrov, Ph.D.
PRINCIPAL INVESTIGATOR
University at Buffalo, SUNY
Frequently Asked Questions
Who can join the NCT05908461 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 6 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05908461 currently recruiting?
Yes, NCT05908461 is actively recruiting participants. Contact the research team at kkasoff@buffalo.edu for enrollment information.
Where is the NCT05908461 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT05908461 clinical trial?
NCT05908461 is sponsored by State University of New York at Buffalo. The principal investigator is Jamie M Ostrov, Ph.D. at University at Buffalo, SUNY. The trial plans to enroll 600 participants.