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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 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.
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
Conditions Studied
Interventions
- BEHAVIORAL Early Childhood Friendship Project
Study Locations (1)
New York
- University at Buffalo, SUNY - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2027-04-16 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05908461
The ClinicalTrials.gov registry entry for NCT05908461 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 647-participant average among 1,090 other Healthy trials with a reported enrollment target. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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