Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05626595 |
| Other study ID # |
H20-01362 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of British Columbia |
| Contact |
Mariana Brussoni |
| Phone |
604-875-3712 |
| Email |
mbrussoni[@]bcchr.ubc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
