PROmoting Early Childhood Outside (PRO-ECO)

NCT ID: NCT05073380

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-06

Brief Summary

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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 our study is to develop, implement and test a comprehensive multi-component intervention, 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.

Our overarching goal is to develop and evaluate a comprehensive multi-component intervention, called the PROmoting Early Childhood Outside (PRO-ECO). This intervention 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. The 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 intervention will be co-developed, implemented and evaluated in partnership with the YMCA of Greater Vancouver (YMCAGV). A wait-list control cluster randomised trial design (RCT) will evaluate the effectiveness of the intervention and how it can be modified to tackle barriers in diverse settings.

Detailed Description

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The design of this study is a pilot wait-list control cluster randomised trial (RCT) with two arms. The two arms consist of 1) a PRO-ECO intervention group and 2) a wait-list control group. 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 intervention. Qualitative data will be collected concurrently with quantitative data and will allow researchers to explore how participants experience the intervention.

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. Organization level Inclusion criteria of the ELCCs include approving participation in this study. Following this, sites will be selected based on geographic area and demographics of neighbourhood served, physical characteristics of the ELCC outdoor space (e.g., size, at grade or not), readiness of program (as assessed by YMCA senior staff), and time spent participating in outdoor play. These variables will be measured based on a pretrial inventory and infrastructure survey, and census subdivision. 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 YMCAGV 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 YMCAGV 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 intervention.

The RCT will be conducted in 8 ELCCs operated by the YMCA GV. Individual ELCCs will serve as the unit of randomization, with 4 intervention sites and 4 wait-list control sites composing the final sample. Intervention sites will receive the intervention immediately following baseline data collection, whereas wait-list control sites will receive the intervention 6 months later. Data on outcome measures will be collected at three time points- 1) Time 1 - Baseline, prior to intervention implementation, 2) Time 2 - 6-month follow-up (4 months following implementation of the intervention within the intervention group, and 3) Time 3 - 12-month follow-up (10 months post-intervention for intervention group, 4 months post-intervention for the wait-list control group). Thus, outcome data will assess short-term and long-term outcomes within the intervention group and short-term outcomes within the wait-list control group. Baseline and post-intervention data will be included in the analysis, controlling for the cluster design.

Baseline and post-intervention data collection will occur during the Fall and Spring seasons to ensure similar weather patterns at all time points, which in Metro Vancouver involves extensive rain fall, 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 8 selected YMCA GV 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.

We will inform parents/caregivers of children enrolled in the participating YMCA GV ELCCs about our study in various ways within the YMCA GV organization. This includes via online communications and info sessions. Adult participants for the qualitative focus group be recruited internally through the YMCA GV. When contacted by prospective participants including ECEs and staff, we will provide details of the study through phone or via email. 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. Once procedures are explained and consent reviewed, we will invite participants to sign the consent forms and complete the demographic survey, and email scanned copies to the UBC research team.

For the primary outcome, proportion of play occurrence, in comparison to non-play occurrence, child play behaviours will be assessed utilizing observational behaviour mapping methods. To conduct observational behaviour mapping, two research staff will be on site at each of the 8 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 research staff will be taking video recordings of the quadrants they are observing. Videos will be coded at 15-second intervals for play type, including functional play, play with rules, imaginative play, constructive play, exploratory play, restorative play, and non-play. The proportion of play occurrence (vs. non-play occurrence) will be summarized by treatment group using frequency and percentages. We will compare proportions at baseline and follow-ups.

The diversity of children's play behavior when participating in outdoor play is a secondary outcome, and will be coded in situ and via review of the videos. We 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 intervention early childhood education centre sites after implementation of the PRO-ECO intervention.

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

Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Outdoor play is an essential component of childhood development, including supporting children's cognitive, physical, emotional, and social growth. Currently, the YMCA early learning and child care centres (ELCCs) host children within childcare settings, with outdoor playtime governed by institutional regulations.

Group Type EXPERIMENTAL

Wait List Group - Normal Daily Practice

Intervention Type BEHAVIORAL

ELCCs that are randomly assigned to the waitlist group will participate in their normal daily practice, including standard curriculum and outdoor play time. Once post-data collection is complete, wait list sites will be given the PRO-ECO intervention.

Intervention

The PRO-ECO intervention to increase the quality of outdoor play involves four primary components:

1. Modifying YMCA GV's outdoor play policies The ELCC policy on outdoor play requirements and procedures will be modified in conjunction with YMCA management.
2. ECE training ECEs will undergo training delivered by YMCA of Southwestern Ontario that includes the importance of outdoor risky play, along with other online training tools along with resources on supporting outdoor play. There will also be ongoing as-needed supportive training and mentorship provided by YMCA senior managers and research team, along with peer mentorship and support.
3. ELCC outdoor space modification This includes designing and implementing tailored modifications for each centre's outdoor play space developed by landscape architecture students.
4. Parent engagement We will host parent-engagement events and opportunities to increase knowledge of the importance of outdoor play.

Group Type SHAM_COMPARATOR

Intervention Group - PRO-ECO Intervention

Intervention Type BEHAVIORAL

The PRO-ECO intervention will be tailored to individual sites. Through collection of focus group and baseline data, the intervention will be further refined to provide site-specific adjustments, such as specific materials in the built environment design modification or targeted training. Identified features of effective interventions outlined in the literature have informed the development of the intervention foundation and potential tailoring.

Interventions

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Intervention Group - PRO-ECO Intervention

The PRO-ECO intervention will be tailored to individual sites. Through collection of focus group and baseline data, the intervention will be further refined to provide site-specific adjustments, such as specific materials in the built environment design modification or targeted training. Identified features of effective interventions outlined in the literature have informed the development of the intervention foundation and potential tailoring.

Intervention Type BEHAVIORAL

Wait List Group - Normal Daily Practice

ELCCs that are randomly assigned to the waitlist group will participate in their normal daily practice, including standard curriculum and outdoor play time. Once post-data collection is complete, wait list sites will be given the PRO-ECO intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

-Being early childhood educators (ECEs) or staff (e.g., administrators, directors and supervisors) at the participating YMCA GV ELCCs.

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

30 Months

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Lawson Foundation

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Mariana Brussoni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana Brussoni

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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British Columbia Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Ramsden R, Han CS, Mount D, Loebach J, Cox A, Herrington S, Bundy A, Fyfe-Johnson A, Sandseter EBH, Stone M, Tremblay MS, Brussoni M. An Intervention to Increase Outdoor Play in Early Childhood Education Centers (PROmoting Early Childhood Outside): Protocol for a Pilot Wait-list Control Cluster Randomized Trial. JMIR Res Protoc. 2022 Jul 12;11(7):e38365. doi: 10.2196/38365.

Reference Type DERIVED
PMID: 35819829 (View on PubMed)

Other Identifiers

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H20-03912-A001

Identifier Type: -

Identifier Source: org_study_id