Clinical trial NCT05626595: PROmoting Early Childhood Outside 2.0
Official title: PROmoting Early Childhood Outside (PRO-ECO) 2.0: A Program to Support Outdoor Play in Early Learning and Child Care Centres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Children's outdoor play
Children's outdoor risky play
Early childhood education
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Government of Canada
First posted: 2022-11-25
Enrollment: 307
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Baseline and post-project data collection will occur during the Fall and Spring seasons to ensure similar weather patterns at all time points, which in British Columbia involves extensive rain and snow, depending on geographic area, as weather has been shown to impact outdoor play time.

As per study inclusion criteria, study participants will include children aged 2.5-6 years at 10 selected sites. This also includes the engagement of ECEs, supervisors, and managers. Parents of children will also be invited to participate in focus groups, consent provision, and information sharing. ELCCs will appoint a staff research lead to work closely with the research team on all phases of the project. Recruitment of children and parents will occur through the staff research lead at each ELCC. Letters and/or emails home and face-to- face conversations will promote recruitment. The research team will be actively involved with staff at each site to ensure they are provided information and direction on participant recruitment policies and procedures. The staff research lead at each ELCC will administer consent forms to families.

The investigators will inform parents/caregivers of children enrolled in the participating ELCCs about the study in various ways. This includes via online communications and info sessions. Adult participants for the qualitative focus group be recruited internally through the ELCC.

When contacted by prospective participants including ECEs and staff, the investigators will provide details of the study through phone, email or in-person connections. On the interview day, the consent and the overall interview procedure will be further explained to participants. The focus groups will be conducted through Zoom or in-person. Once procedures are explained and consent reviewed, the investigators will invite participants to sign the consent forms and complete the demographic survey, and email scanned copies to the UBC research team.

The outcome measures and methods for this study will be co-created with the project partners and may change after consultation. However, an overview of methods used within the pilot project that will guide this consultation are provided below.

For the primary outcome, children's time spent in bio play (engagement with natural environment elements) will be assessed utilizing observational behaviour mapping methods. To conduct observational behaviour mapping, two research staff will be on site at each of the 10 ELCCs to collect pre-determined data related to play behaviour during outdoor free play. Behaviour mapping assessments will be performed through scanning identified quadrants throughout the outdoor play space. Simultaneous to the in- situ coding, the project team, including research staff and ECE's, will be taking video recordings of the quadrants they are observing. Videos will be coded at 15-second intervals for play type, including bio play, physical play, expressive play, play with rules, imaginative play, exploratory play, restorative play, and non-play. Children's time spent in bio play will be calculated by adding up all measured/recorded time spent engaged in bio play. The investigators will compare time spent in bio play versus other play types at baseline and follow-up.

Children's participation in outdoor play will be assessed as a secondary outcome by comparing participation in play vs. non-play. Children's time spent in outdoor play will be calculated by adding up all measured/recorded time spent engaged in any type of play, excluding non-play. The diversity of children's play behavior when participating in outdoor play is also a secondary outcome and will be coded via observational behavior mapping methods. The investigators will compare the diversity of types of play occurring at baseline and follow- up by comparing proportions of the various play types, including physical play, expressive play, play with rules, imaginative play, exploratory play, restorative play, bio play, digital play and non-play.

ECEs' attitudes toward outdoor risky play is a secondary outcome and will be assessed using the Teacher Tolerance of Risk in Play Scale (T-TRiPS).

The quality of outdoor spaces will be an additional outcome. The Seven Cs audit tool will form the basis for the assessment of quality of outdoor space at all early childhood education centre sites, guide development of the plan for modification of the outdoor environment, and to reassess at main project early childhood education centre sites after implementation of the PRO-ECO project.

The same procedures described above will be followed to collect post- project data. The investigators will also collect ECEs and staff's acceptability of the PRO- ECO project. This will be done utilizing a combination of focus group discussion and administrative data.

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

1. The ELCC site inclusion criteria:

   We will select ELCCs providing full day care to preschool children to include in the study in consideration of readiness of program to participate and perceived need for the program, and time spent.
2. Adult participation inclusion criteria:

   Being early childhood educators (ECEs) or staff (e.g., administrators, directors and supervisors) at the participating ELCCs.
3. Child participation inclusion criteria:

   * Being between the ages of 2.5 to 6 years;
   * Currently enrolled in one of the participating ELCCs;
   * Obtained parental consent for their participation in the study.

Primary outcomes:
measure: Assessing children's time spent in bio play
timeFrame: 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)
Secondary outcomes:
measure: Assessing the diversity of play types children engage in
timeFrame: 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)
measure: Quality of early childhood education centres' outdoor play spaces
timeFrame: Project and Wait-list Control Group - Change in Seven C's Score at 5-months post-project implementation (Spring 2024; Fall 2024)
measure: Early childhood educators' attitudes towards outdoor risky play
timeFrame: Project and Wait-list Control Group - Change in educators' attitudes at 5-months post-project implementation (Spring 2024; Fall 2024)
measure: Acceptability and feasibility of PRO-ECO project
timeFrame: Project and Wait-list Control Group - Change in educator and parent perspectives at 5-months post-project implementation (Spring 2024; Fall 2024)
measure: Assessing children's time spent in outdoor play
timeFrame: 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)
Other outcomes:
Locations:
city: Canal Flats
country: Canada
facility: Curious Minds
state: British Columbia
city: Cariboo
country: Canada
facility: Outdoor Paradise
state: British Columbia
city: Chetwynd
country: Canada
facility: Turtle Island
state: British Columbia
city: Cranbrook
country: Canada
facility: Kinnikinnick
state: British Columbia
city: Fort St. James
country: Canada
facility: NW
state: British Columbia
city: Grand Forks
country: Canada
facility: Ogopogo
state: British Columbia
city: Lytton
country: Canada
facility: Bird's Nest
state: British Columbia
city: Surrey
country: Canada
facility: Lily of the Valley
state: British Columbia
city: Victoria
country: Canada
facility: The Nest
state: British Columbia
city: Windermere
country: Canada
facility: Kulilu
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mariana Brussoni
role: PRINCIPAL_INVESTIGATOR
References: