Early Childhood Friendship Project for Healthy Preschoolers

(ECFP-3 Trial)

Overseen By Kristin Tymchak, M.A./A.C.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the Early Childhood Friendship Project can help preschoolers improve social skills and reduce aggressive behaviors. The program includes fun activities like puppet shows and games, led by teachers with coaching. Researchers aim to determine if these activities can enhance children's ability to make friends, manage emotions, and succeed academically, especially as they transition to kindergarten. Preschool children in the greater Buffalo area who will start kindergarten in the fall are ideal candidates for this trial. As an unphased trial, this study provides a unique opportunity for children to enhance their social skills in a supportive and engaging environment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that the Early Childhood Friendship Project is safe for preschoolers?

Research has shown that the Early Childhood Friendship Project (ECFP) has been thoroughly studied. These studies have not reported any major safety issues or harmful effects. As a behavioral program, not a medication or medical device, the ECFP uses fun activities like puppet shows and games to teach preschoolers social skills.

The program's activities are generally safe and similar to those in early childhood education settings. Since it doesn't involve physical treatment, the risks remain very low. Previous research has mainly focused on its impact on behavior rather than safety. Therefore, participants can expect the program to be safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Childhood Friendship Project because it takes a playful and interactive approach to improving social skills in preschoolers. Unlike traditional methods that might focus on structured lessons or therapist-led sessions, this project uses puppet shows and engaging activities to naturally encourage children to develop friendships and social behaviors. This creative method could lead to more effective and enjoyable learning experiences for children, potentially making a significant impact on their social development.

What evidence suggests that the Early Childhood Friendship Project is effective for improving social and academic competence in preschoolers?

Research has shown that the Early Childhood Friendship Project, which participants in the intervention group of this trial will receive, can help reduce aggression and improve social skills in young children. Studies found that children in the program experienced moderate decreases in both physical and relational aggression. They also improved in prosocial behaviors, such as sharing and cooperating with others. The program enhanced children's social skills and academic performance. These positive changes appeared not only immediately after the program but also persisted over time, indicating long-term benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Jamie M Ostrov, Ph.D.

Principal Investigator

University at Buffalo, SUNY

Are You a Good Fit for This Trial?

This trial is for children attending certain child care centers in the Buffalo region of New York who are planning to start kindergarten in the fall. There are no specific exclusion criteria, so it appears open to all eligible children at these centers.

Inclusion Criteria

A child 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

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Early Childhood Friendship Project intervention, including puppet shows, motor activities, and behavioral reinforcement

8 weeks

Multiple school-based sessions

Follow-up

Participants are monitored for changes in aggression, prosocial behavior, and academic competence

4 months

Assessments at 4 months post-intervention

Extended Follow-up

Long-term monitoring of intervention effects on school readiness and transition to kindergarten

12 months

Assessments at 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Early Childhood Friendship Project

Trial Overview

The Early Childhood Friendship Project (ECFP) aims to improve kids' social skills and reduce aggression by having teachers implement a program with coaching support. The study will track changes over time, including after the kids start kindergarten.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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).

Group II: Control Group Active Control 1 Intervention

Participants will not receive the Early Childhood Friendship project intervention.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The 2-year implementation of the CATCH EC program in preschool settings led to a significant reduction in child BMI z-scores and BMI percentiles among 3- to 5-year-olds in intervention centers, indicating its effectiveness in addressing obesity in low-income populations.

Despite the positive impact on BMI, the program did not result in significant changes in children's dietary habits, physical activity levels, or screen time behaviors, suggesting that while the program can reduce obesity rates, additional strategies may be needed to improve overall lifestyle behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Coordinated Approach to Child Health Early Childhood Program for Obesity Prevention among Preschool Children: The Texas Childhood Obesity Research Demonstration Study. Sharma, SV., Vandewater, E., Chuang, RJ., et al.[2020]

Mealtimes in early childhood education and care (ECEC) settings are crucial for promoting healthy eating behaviors and social interactions among children, as observed in a study of 47 mealtimes across two centers.

The study identified five key outcomes from mealtimes—rituals, learning moments, food preference development, socialization, and child agency—highlighting how these interactions can help shape children's food preferences and community bonds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culture and community: observation of mealtime enactment in early childhood education and care settings. Harte, S., Theobald, M., Trost, SG.[2020]

The E4Kids study is a comprehensive 5-year longitudinal research project involving 2,494 children in various Early Childhood Education and Care (ECEC) programs, aimed at identifying which components of these programs enhance children's learning, development, and social inclusion.

By assessing the quality of adult-child interactions and tracking children's progress to their Year 3 NAPLAN testing, the study seeks to provide evidence that can inform policy decisions and improve the quality of ECEC in Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of Australian early childhood education and care experiences: study protocol. Tayler, C., Cloney, D., Adams, R., et al.[2019]

The Early Support Pilot Programme is a government initiative designed to enhance assessment and support for children under three with complex health needs, focusing on a family-centered approach.

The program promotes collaboration among professionals and families through joint assessments and coordinated care, exemplified by a local pilot site experience that illustrates its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with special needs--2: The Early Support Pilot Programme. Savage, M.[2016]

The study highlighted that many preschool children identified with motor, behavioral, or learning difficulties during health examinations were at risk for adjustment problems in grade 1.

Collaboration among preschool establishments, child health care centers, and schools is crucial for early identification of children who may face challenges, allowing for timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health examination of preschool children in relation to school adjustment in grade I. Bondestam, M., Hagelin, E., Rydell, AM., et al.[2019]

Out of 499 clinical trials reviewed for children with chronic conditions, only 36 included activity and participation outcomes, indicating a significant gap in assessing child-important health in these studies.

Non-drug trials and late-phase trials (phase IV) were more likely to include activity and participation outcomes, suggesting that the type and stage of the trial influence the comprehensiveness of health outcome assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions. Fayed, N., de Camargo, OK., Elahi, I., et al.[2021]

The Healthy Kids model is an innovative health promotion strategy designed to build capacity in early childhood education and care (ECEC) sectors, specifically targeting communities in Queensland with higher developmental vulnerabilities.

This model emphasizes a low-cost, sustainable approach by establishing localized communities of practice, which fosters partnerships and community ownership, ultimately aiming to improve health outcomes for children in socio-economically disadvantaged areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Healthy Kids"-A capacity building approach for the early childhood education and care sector. Brown, A., Philipson, A., Dunstan, K., et al.[2023]

Children hospitalized with chronic health conditions show significant academic underperformance, with 16%-18% performing below the national minimum standard in literacy and numeracy, compared to their peers.

The frequency of hospitalizations correlates with increased odds of academic underperformance, particularly among those hospitalized for mental health issues, highlighting the need for targeted health and educational support to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School academic performance of children hospitalised with a chronic condition. Hu, N., Fardell, J., Wakefield, CE., et al.[2022]

In a study of 102 children admitted to intensive care for acute alcohol intoxication, 57% required intubation, with the need for intubation linked to lower Glasgow Coma Scale scores, lower body temperature, and higher blood alcohol concentrations.

The majority of patients were male adolescents, and while metabolic disturbances like high lactate levels and hyperglycemia were common, serious complications typically seen in adults, such as electrolyte imbalances and aspiration pneumonia, were rare in this pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Acute Alcohol Intoxication Admitted to the ICU: A Review of 102 Cases in France. Ruetsch, V., Zarka, J., Vanel, B., et al.[2021]

Structured active play during cancer treatment can significantly enhance personal and social development in preschoolers, as observed in a study involving 15 children aged 1-5 over a year.

Children expressed a strong desire to play and showed improved confidence in their physical abilities and social skills, highlighting the importance of parental and healthcare support in facilitating these activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of structured active play for social and personal development in preschoolers during cancer treatment: A qualitative RePlay study. Pouplier, A., Fridh, MK., Christensen, J., et al.[2023]

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In T3 (June – July), we collected data on children's outcomes (i.e., friendship quality) and the length of exposure to the ECE teacher, both reported by ECE ...