The Early Childhood Friendship Project - Phase 3 (ECFP-3)

September 29, 2025 updated by: Jamie M. Ostrov, Ph.D., State University of New York at Buffalo

The Early Childhood Friendship Project: Testing Key Mechanisms and the Moderating Role of Physiological Reactivity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14260
        • Recruiting
        • University at Buffalo, SUNY
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: 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.
No Intervention: Control Group
Participants will not receive the Early Childhood Friendship project intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)
Time Frame: Up to 12 weeks post-intervention completion.
Physical aggression will be assessed via focal child sampling with continuous recording observation for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
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.
Prosocial behavior will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
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.
Relational aggression will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
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.
Physical victimization will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
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.
Relational victimization will be assessed via focal child sampling with continuous recording observations for each participating child. Each observation is 10 minutes for up to 8 separate observations (i.e., frequency counts divided by number of sessions out of 8 sessions).
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.
Sound fluency will be measured using the DIBELS - Sound Fluency measure. Scores are calculated as the correct initial sounds per minute, with higher scores indicating greater performance on this measure.
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.
Letter naming fluency will be measured using the DIBELS - Letter Naming Fluency measure. Scores on this measure range from 0 to 110, with higher scores indicating greater performance.
Up to 4 months post-intervention completion.
Early Numeracy Skills: Set Comparison
Time Frame: Up to 4 months post-intervention completion.
Early numeracy will be assessed using the task set comparisons. In this activity, a child is presented with four sets of dots representing different amounts and asked which has the most or fewest dots. A child's score is a sum of correct responses. Scores range from 0-6, with higher scores indicating stronger performance.
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 will be assessed using the task one-to-one counting. In this task, a child is presented with a set of dots and asked to count the set. A child's score is sum of correct responses. Scores range from 0 to 5, with higher scores indicating stronger performance.
Up to 4 months post-intervention completion.
Early Numeracy Skills: Verbal Counting
Time Frame: Up to 4 months post-intervention completion.
Early numeracy will be assessed using the task verbal counting. In this task, a child is asked to count as high as possible until the child makes a mistake or correctly counts up to 100. A child's score is a single score based on correct counting out of 100. Scores range from 1-7, with higher scores indicating stronger performance.
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.
Teachers will complete the PPVM-T-R Relational Victimization subscale to assess relational victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of relational victimization.
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.
Teachers will complete the PPVM-T-R physical victimization subscale to assess physical victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
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.
Research assistant observers will complete the PPVM-T-R physical victimization subscale to assess physical victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
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.
Research assistant observers will complete the PPVM-T-R relational aggression subscale to assess relational victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
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.
Research assistant observers will complete the PPVM-T-R physical victimization to assess physical victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
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.
Research assistant observers will complete the PPVM-T-R relational victimization subscale to assess relational victimization. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical victimization.
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.
Teachers will complete the PSBS-TR physical aggression subscale to assess physical aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
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.
Teachers will complete the PSBS-TR relational aggression subscale to assess relational aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of relational aggression.
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.
Teachers will complete the PSBS-TR prosocial behavior subscale to assess prosocial behavior. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of prosocial behavior.
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.
Research assistant observers will complete the PSBS-TR relational aggression subscale to assess relational aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of relational aggression.
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.
Research assistant observers will complete the PSBS-TR physical aggression subscale to assess physical aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
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.
Research assistant observers will complete the PSBS-TR prosocial behavior subscale to assess prosocial behavior. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
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.
Research assistant observers will complete the PSBS-TR physical aggression subscale to assess physical aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
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.
Research assistant observers will complete the PSBS-TR relational aggression subscale to assess relational aggression. Raw scores are 6-30 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of relational aggression.
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.
Research assistant observers will complete the PSBS-TR prosocial behavior subscale to assess prosocial behavior. Raw scores are 4-20 with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of physical aggression.
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.
Teachers will complete the HBQ school performance subscale to assess academic competence. Raw scores range from 5-25 with average scores on this measure ranging from 1-5, and with higher scores indicate higher levels of academic competence.
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.
Teachers will complete the HBQ school performance subscale to assess academic competence. Raw scores range from 5-25, with average scores on this measure ranging from 1-5, and with higher scores indicating higher levels of academic competence.
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.
Teachers will complete the HBQ school engagement subscale to assess school engagement. Raw scores range from 0-16, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of school engagement.
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.
Teachers will complete the HBQ school engagement subscale to assess school engagement. Raw scores range from 0-16, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of school engagement.
An average of 12 months post-intervention completion.
Social Skills Rating Scale (SSRS)
Time Frame: An average of 12 months post-intervention completion.
Teachers will complete this standard measure of social skills. Raw scores range from 0 to 60, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of social skills.
An average of 12 months post-intervention completion.
Social Skills Rating Scale (SSRS)
Time Frame: Up to 12 weeks post-intervention completion.
Research assistant observers will complete this standard measure of social skills. Raw scores range from 0 to 60, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of social skills.
Up to 12 weeks post-intervention completion.
Social Skills Rating Scale (SSRS)
Time Frame: Up to 4 months post-intervention completion.
Research assistant observers will complete this standard measure of social skills. Raw scores range from 0 to 60, with average scores on this measure ranging from 0-2, and with higher scores indicating higher levels of social skills.
Up to 4 months post-intervention completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie M Ostrov, Ph.D., University at Buffalo, SUNY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004375
  • 1R01HD105496-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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