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NCT05908461 · ClinicalTrials.gov registry record · NA

The Early Childhood Friendship Project - Phase 3

A NA study of Healthy, sponsored by State University of New York at Buffalo.

Recruiting
Registry status
NA
Development phase
600
Enrollment target
1
Study location

NCT05908461: Recruiting NA study of Healthy, sponsored by State University of New York at Buffalo.

NCT05908461 is a NA study of Healthy that is actively recruiting participants, run by State University of New York at Buffalo. The registered enrollment target is 600 participants, roughly in line with the 647-participant average among 1,090 other Healthy trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05908461, a NA study of Healthy, is actively recruiting participants, sponsored by State University of New York at Buffalo.

RECRUITING
Registry status
NA
Development phase
600 participants
Enrollment target
1
Study location

Study 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 wi

Primary Outcome

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).

Conditions Studied

Interventions

  • BEHAVIORAL Early Childhood Friendship Project

Study Locations (1)

New York

  • University at Buffalo, SUNY - Buffalo

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2023-08-16
Est. Completion 2027-04-16
Phase NA

What NCT05908461 shows while recruiting

NCT05908461 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 647-participant average among 1,090 other Healthy trials with a reported enrollment target.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Early Childhood Friendship Project is the first listed.

NCT05908461 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05908461 about?

NCT05908461 is a clinical study titled "The Early Childhood Friendship Project - Phase 3". 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 wi...

What is the current status of trial NCT05908461?

This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2023-08-16. Estimated completion is 2027-04-16.

What conditions does trial NCT05908461 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT05908461?

The interventions under investigation include: Early Childhood Friendship Project (BEHAVIORAL).

Who is sponsoring clinical trial NCT05908461?

This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05908461 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05908461's enrollment target sits among peer trials

600 43rd of 1090 higher than 1,046 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05908461, the US trial registry maintained by the National Library of Medicine. NCT05908461 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.