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临床试验/NCT05626595
NCT05626595已完成不适用

PROmoting Early Childhood Outside (PRO-ECO) 2.0: A Program to Support Outdoor Play in Early Learning and Child Care Centres

University of British Columbia10 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
10
主要终点
Assessing children's time spent in bio play

研究概览

简要总结

Licensed early learning and childcare centres (ELCCs) can provide children with rich opportunities for outdoor play that they may not otherwise experience in their home or community. However, many ELCCs struggle to provide high quality and stimulating outdoor play time. The primary aim of this study is to develop, implement and test a comprehensive multi-component project, the PROmoting Early Childhood Outside (PRO-ECO), to build capacity for, and address the complexities of building support for outdoor play in early childcare centre settings. This is to ultimately increase children's access to engaging outdoor spaces for play.

The overarching goal of this project is to develop and evaluate a comprehensive multi- component project, called the PROmoting Early Childhood Outside (PRO- ECO). This project is to increase children's outdoor play and the diversity of outdoor play behaviour in Canadian ELCC settings providing full-day licensed care for preschoolers. PRO-ECO integrates development of policies and procedure, early childhood educator (ECE) training and mentorship, outdoor space modifications and, parent/caregiver engagement.

The PRO-ECO project will be co-developed, implemented and evaluated in partnership with provincial childcare organizations and ten ELCCs. A wait-list control cluster randomised trial design (RCT) will evaluate the effectiveness of the project and how it can be modified to tackle barriers in diverse settings.

This project is an extension of the PRO-ECO pilot study (protocol ID H20-03912-A001, Clinicaltrials.gov ID NCT05073380).

详细描述

The design of this study is a wait-list control cluster randomised trial (RCT) with two arms. The two arms consist of 1) a PRO-ECO first project group and 2) a wait-list control group. The PRO-ECO project implementation consists of 4 primary components: 1) modifying existing/developing new ELCC policies and procedures related to outdoor play, 2) ECE training and mentorship through the Learning Outside Together program, providing outdoor play pedagogy theory and application, 3) ELCC outdoor space modification, and 4) parent and caregiver engagement of outdoor play activities.

A mixed-methods approach will be used to collect qualitative and quantitative data designed to meet the study objectives. Quantitative data collection will support evaluation of the primary outcome variables and qualitative data will be collected to assess the acceptability, effectiveness, and feasibility of the implementation of the project. Qualitative data will be collected concurrently with quantitative data and will allow researchers to explore how participants experience the project.

Participant inclusion and exclusion criteria are divided into three distinct sets of levels- 1) organization level, 2) adult individual participation, and 3) child participation.

  1. Organization level Inclusion criteria of the ELCCs include approving participation in this study, readiness of the ELCC to participate and perceived need for the project (as assessed by the project partners and via interviews with the ELCCs). These variables will be measured based on a pretrial interview with ELCCs and key informants from the project steering committee. ELCCs that do not meet the inclusion characteristics based on these measurements may be excluded.
  2. Adult individual participation Inclusion criteria for adult participants include being ECEs or staff (administrators, directors, and supervisors) at the participating ELCCs that provide full day childcare for preschool children.
  3. Child individual participation Inclusion criteria for child participation includes being between the ages of 2.5-6 years, currently enrolled in one of the participating ELCCs, and obtaining parental consent for their participation in the study. Children will be excluded from the measurement portion of the study if their parent does not provide informed consent, however, all children attending the program will be exposed to the project.

The RCT will be conducted in 10 ELCCs across British Columbia. Individual ELCCs will serve as the unit of randomization, with 5 project sites and 5 wait-list control sites composing the final sample. Main project sites will receive the project deliverables immediately following baseline data collection, whereas wait-list control sites will receive the project deliverables 6 months later. Data on outcome measures will be collected at three time points: 1) Time 1 - Baseline, prior to project implementation, 2) Time 2 - 6-month follow-up (4 months following implementation of the project within the main project group, and 3) Time 3 - 12-month follow-up (10 months post-project for the main project group, 4 months post-intervention for the wait-list control group). Thus, outcome data will assess short-term and long-term outcomes within the project group and short-term outcomes within the wait-list control group. Baseline and post-project data will be included in the analysis, controlling for the cluster design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Months 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Assessing children's time spent in bio play

时间窗: Project Group - Change of prevalence of bio play at 5-months and 10-months post-project implementation (Spring 2024 and Fall 2024); Wait List Control Group - Change of prevalence of bio play at 5-months post-project implementation (Fall 2024)

To assess children's participation play that includes interaction with natural environment elements at ELCCs, an observational behavior mapping (OBM) methodology will be used. OBM involves understanding how an environment supports movement through mapping, recording, and analyzing geographically located data.

次要结局

  • Quality of early childhood education centres' outdoor play spaces(Project and Wait-list Control Group - Change in Seven C's Score at 5-months post-project implementation (Spring 2024; Fall 2024))
  • Assessing the diversity of play types children engage in(Project Group - Change in play diversity at 5-months and 10-months post-project implementation (Spring 2024 and Fall 2024); Wait List Control Group - Change in play diversity at 5-months post-project implementation (Fall 2024))
  • Acceptability and feasibility of PRO-ECO project(Project and Wait-list Control Group - Change in educator and parent perspectives at 5-months post-project implementation (Spring 2024; Fall 2024))
  • Early childhood educators' attitudes towards outdoor risky play(Project and Wait-list Control Group - Change in educators' attitudes at 5-months post-project implementation (Spring 2024; Fall 2024))
  • Assessing children's time spent in outdoor play(Project Group - Change of prevalence of play at 5-months and 10-months post-project implementation (Spring 2024 and Fall 2024); Wait List Control Group - Change of prevalence of play at 5-months post-project implementation (Fall 2024))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Brussoni

Principle Investigator

University of British Columbia

研究点 (10)

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