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HealthyECFP-3NCT05908461

The Early Childhood Friendship Project - Phase 3

A study testing Early Childhood Friendship Project in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Early Childhood Friendship Project
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
16 Aug 2023to 16 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katherine Kasoff, B.A. contact

716-645-1777

kkasoff@buffalo.edu

United States1 site, 1 recruiting
  • University at Buffalo, SUNY

    Buffalo, New York, 14260

    Katherine Kasoff, B.A., 716-645-1777, kkasoff@buffalo.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Healthy
Being tested
Early Childhood Friendship Project

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Childhood Friendship ProjectBehavioural

    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 groups in NCT05908461
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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).
Receives: Behavioral: Early Childhood Friendship Project
Control GroupNo interventionParticipants will not receive the Early Childhood Friendship project intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observations of Physical Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)

    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).

    Measured: Up to 12 weeks post-intervention completion.

  2. Observations of Prosocial Behavior (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)

    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).

    Measured: Up to 12 weeks post-intervention completion.

  3. Observations of Relational Aggression (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)

    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).

    Measured: Up to 12 weeks post-intervention completion.

  4. Observations of Physical Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)

    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).

    Measured: Up to 12 weeks post-intervention completion.

  5. Observations of Relational Victimization (Early Childhood Observation System - Frequency Count up to 8 Sampling Sessions)

    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).

    Measured: Up to 12 weeks post-intervention completion.

  6. Dynamic Indicators of Basic Early Learning (DIBELS) - Sound Fluency

    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.

    Measured: Up to 4 months post-intervention completion.

  7. Dynamic Indicators of Basic Early Learning (DIBELS) - Letter Naming Fluency

    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.

    Measured: Up to 4 months post-intervention completion.

  8. Early Numeracy Skills: Set Comparison

    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.

    Measured: Up to 4 months post-intervention completion.

  9. Early Numeracy Skills: One-to-One Counting

    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.

    Measured: Up to 4 months post-intervention completion.

  10. Early Numeracy Skills: Verbal Counting

    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.

    Measured: Up to 4 months post-intervention completion.

  11. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  12. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  13. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  14. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  15. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Physical Victimization Subscale

    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.

    Measured: Up to 4 months post-intervention completion.

  16. Preschool Peer Victimization Measure - Teacher Report - Revised (PPVM-T-R): Relational Victimization Subscale

    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.

    Measured: Up to 4 months post-intervention completion.

  17. Preschool Social Behavior Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  18. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  19. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  20. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  21. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  22. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  23. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Physical Aggression Subscale

    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.

    Measured: Up to 4 months post-intervention completion.

  24. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Relational Aggression Subscale

    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.

    Measured: Up to 4 months post-intervention completion.

  25. Preschool Social Behavioral Scale - Teacher Report (PSBS-TR): Prosocial Behavior Subscale

    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.

    Measured: Up to 4 months post-intervention completion.

  26. MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  27. MacArthur Health and Behavior Questionnaire (HBQ) - School Performance Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  28. MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale

    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.

    Measured: Up to 12 weeks post-intervention completion.

  29. MacArthur Health and Behavior Questionnaire (HBQ) - School Engagement Subscale

    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.

    Measured: An average of 12 months post-intervention completion.

  30. Social Skills Rating Scale (SSRS)

    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.

    Measured: An average of 12 months post-intervention completion.

  31. Social Skills Rating Scale (SSRS)

    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.

    Measured: Up to 12 weeks post-intervention completion.

  32. Social Skills Rating Scale (SSRS)

    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.

    Measured: Up to 4 months post-intervention completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start16 Aug 2023
  3. Primary completion16 Apr 2027 (estimated)
  4. Study completion16 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908461
Sponsor's protocol ID
STUDY00004375
Other IDs
1R01HD105496-01A1
Acronym
ECFP-3
Status last verified
Sep 2026
First submitted
25 May 2023
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Early Childhood Friendship Project in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katherine Kasoff, B.A. (716-645-1777, kkasoff@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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