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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Early Childhood Friendship Project treatment?

The study on structured active play for preschoolers during cancer treatment suggests that such activities can promote social and personal development, which may support the effectiveness of the Early Childhood Friendship Project in fostering healthy social interactions among preschoolers. ^{1 2 3 4 5}

How is the Early Childhood Friendship Project treatment different from other treatments for preschoolers?

The Early Childhood Friendship Project is unique because it focuses on fostering social skills and friendships among preschoolers, which is not typically the primary focus of other treatments that often emphasize physical health or academic readiness. This approach aims to improve social development and peer interactions, which can have long-term benefits for children's emotional and social well-being. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jamie M Ostrov, Ph.D.

Principal Investigator

University at Buffalo, SUNY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions. [2021]

3. England pubmed.ncbi.nlm.nih.gov

School academic performance of children hospitalised with a chronic condition. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pediatric Acute Alcohol Intoxication Admitted to the ICU: A Review of 102 Cases in France. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of Australian early childhood education and care experiences: study protocol. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

"Healthy Kids"-A capacity building approach for the early childhood education and care sector. [2023]

8. United States 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. [2020]

9. Norway pubmed.ncbi.nlm.nih.gov

Health examination of preschool children in relation to school adjustment in grade I. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Culture and community: observation of mealtime enactment in early childhood education and care settings. [2020]