Clinical trial NCT05073380: PROmoting Early Childhood Outside (PRO-ECO)
Official title: PROmoting Early Childhood Outside (PRO-ECO): An Outdoor Play Intervention for Children Aged 3 to 5 Years in Early Childhood Education 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: The Lawson Foundation
First posted: 2021-10-11
Enrollment: 333
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 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: 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.

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 YMCAGV ELCC site inclusion criteria:

   We will select ELCCs providing full day care to preschool children to include in the study in consideration of different variables - 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 further explored with the YMCA GV to determine priority site inclusion criteria and finalize site selection.
2. Adult participation inclusion criteria:

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

   * 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.

Primary outcomes:
measure: Assessing child participation in outdoor free play by identifying prevalence of play
timeFrame: Intervention Group - Change of prevalence of play at 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Change of prevalence of play at 5-months post-intervention (Fall 2022)
Secondary outcomes:
measure: Assessing the diversity of play types children engage in
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Quality of early childhood education centres' outdoor play spaces
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Early childhood educators' attitudes towards outdoor risky play
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Acceptability and feasibility of PRO-ECO intervention
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Economic analysis of PRO-ECO intervention
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
Other outcomes:
measure: Children's psychosocial strengths
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Children's relationship to outdoor play
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Child health
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
measure: Child well-being
timeFrame: Intervention Group - Baseline (Fall 2021), 5-months/10-months post-intervention (Spring 2022/Fall 2022); Wait List Control Group - Baseline/post-baseline (Fall 2021/Spring 2022), 5-months post-intervention (Fall 2022)
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mariana Brussoni
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.