Recruiting

Early Childhood Friendship Project

Sponsor:

State University of New York at Buffalo

Code:

NCT05908461

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Accepted

Interventions

Early Childhood Friendship Project

Study Details

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.

Conditions

Healthy

Study ID

NCT05908461

Start date

Aug 16, 2023

Status verified date

Jun, 2026

Completion date

Apr 16, 2027

Anticipated

Primary completion date

Apr 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Early Childhood Friendship Project

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.

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. ]
  • Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions) [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency [ Time Frame: Up to 4 months post-intervention completion. ]
  • Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency [ Time Frame: Up to 4 months post-intervention completion. ]
  • Early Numeracy Skills: Set Comparison [ Time Frame: Up to 4 months post-intervention completion. ]
  • Early Numeracy Skills: One-to-One Counting [ Time Frame: Up to 4 months post-intervention completion. ]
  • Early Numeracy Skills: Verbal Counting [ Time Frame: Up to 4 months post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale [ Time Frame: Up to 4 months post-intervention completion. ]
  • Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale [ Time Frame: Up to 4 months post-intervention completion. ]
  • Preschool Social Behavior Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale [ Time Frame: Up to 4 months post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale [ Time Frame: Up to 4 months post-intervention completion. ]
  • Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale [ Time Frame: Up to 4 months post-intervention completion. ]
  • MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale [ Time Frame: An average of 12 months post-intervention completion. ]
  • Social Skills Rating Scale (SSRS) [ Time Frame: An average of 12 months post-intervention completion. ]
  • Social Skills Rating Scale (SSRS) [ Time Frame: Up to 12 weeks post-intervention completion. ]
  • Social Skills Rating Scale (SSRS) [ Time Frame: Up to 4 months post-intervention completion. ]

Central Contacts and Locations

Central contacts

Katherine Kasoff, B.A.

914-327-9756kkasoff@buffalo.edu

Locations

University at Buffalo, SUNY

Recruiting

Buffalo, New York, United States, 14260

Contacts

Katherine Kasoff, B.A.

914-327-9756kkasoff@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jul 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-07-08.