The Early Childhood Friendship Project - Phase 3

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT05908461
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
4 Years - 6 Years
Healthy Volunteers
Accepted

Interventions

  • Early Childhood Friendship Project — BEHAVIORAL
    Classroom-based intervention where teachers will implement 8 10-minute puppet shows, 7 5-minute active gross motor activities to reinforce the social skill of the week, and 7 5-minute passive rehearsal activities such as making their own puppet and practicing the steps of the week. Up to three 1 hour in vivo behavioral reinforcement periods will occur per week and during these free play sessions teachers and the main puppet will use developmentally appropriate praise to reinforce the use of the social skills of the week.

Study Details

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.

Key Dates

Start date
Aug 16, 2023
Status verified
Sep 2025
Primary completion
Apr 16, 2027
Completion
Apr 16, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Intervention Group
    Participants will receive the Early Childhood Friendship project intervention (8x10-min puppet shows, 7x5-min gross motor activities7x5-min passive activities, up to 3x1-hour in-vivo behavioral reinforcement periods).
  • No Intervention: Control Group
    Participants will not receive the Early Childhood Friendship project intervention.

Primary Outcome Measure

Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [ Time Frame: Up to 12 weeks post-intervention completion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University at Buffalo, SUNYBuffaloNew York14260
Kristin Tymchak, M.A./A.C.
[email protected]
716-645-0213

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By research site
University at Buffalo, SUNY· Buffalo, NY

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