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Outdoor Play Intervention for Child Development (PRO-ECO2 Trial)

N/A
Recruiting
Led By Mariana Brussoni
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant inclusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

PRO-ECO2 Trial Summary

This trial seeks to increase children's access to engaging outdoor spaces for play, by developing and evaluating a comprehensive project to build capacity for outdoor play in Early Learning and Childcare Centres.

Who is the study for?
This trial is for licensed early learning and childcare centres (ELCCs) that want to improve outdoor play quality for preschoolers. Centres participate in a program aiming to enhance outdoor spaces, train staff, and engage parents. ELCCs not already providing full-day care or unable to commit to the project's duration are excluded.Check my eligibility
What is being tested?
The PRO-ECO Project is being tested against normal daily practices at ELCCs. The project includes policy development, educator training, space modifications, and parent engagement to increase children's diverse outdoor play behaviors. Effectiveness will be measured using a wait-list control cluster randomized trial design.See study design
What are the potential side effects?
Since this study involves organizational changes rather than medical interventions, there are no direct side effects like those associated with drugs or medical treatments. However, unintended consequences may include resistance to change or additional workload for staff.

PRO-ECO2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PRO-ECO2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~project and wait-list control group - change in seven c's score at 5-months post-project implementation (spring 2024; fall 2024)
This trial's timeline: 3 weeks for screening, Varies for treatment, and project and wait-list control group - change in seven c's score at 5-months post-project implementation (spring 2024; fall 2024) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing children's time spent in bio play
Secondary outcome measures
Acceptability and feasibility of PRO-ECO project
Assessing children's time spent in outdoor play
Assessing the diversity of play types children engage in
+2 more

PRO-ECO2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ControlExperimental Treatment1 Intervention
Outdoor play is an essential component of childhood development, including supporting children's cognitive, physical, emotional, and social growth. Currently, the early learning and childcare centres (ELCCs) host children within childcare settings, with outdoor playtime governed by institutional regulations.
Group II: ProjectPlacebo Group1 Intervention
The PRO-ECO project to increase the quality of outdoor play involves four primary components: Modifying ELCC's outdoor play policies: the ELCC policy on outdoor play requirements and procedures will be modified in conjunction with ELCC management. ECE training and mentorship: ECEs will undergo the Learning Outside Together (LOT) program, which incorporates traditional wisdom into training on Indigenous ways of knowing, learning and experiencing the land as teacher. ELCC outdoor space modification: This includes designing and implementing tailored modifications for each centre's outdoor play space developed by landscape architecture students. Parent engagement: ELCCs will host parent-engagement events and opportunities to increase knowledge of the importance of outdoor play.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wait List Group - Normal Daily Practice
2021
N/A
~340

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,466,818 Total Patients Enrolled
Government of CanadaOTHER_GOV
12 Previous Clinical Trials
2,067 Total Patients Enrolled
Mariana BrussoniPrincipal InvestigatorUniversity of British Columbia
2 Previous Clinical Trials
896 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are carrying out this experiment?

"This clinical trial can be accessed at 10 different medical sites, including Turtle Island in Chetwynd, Ogopogo in Grand Forks and The Nest in Victoria. Additionally, there are other accessible locations available for patients to consider."

Answered by AI

Are volunteers currently being accepted for this research endeavor?

"Affirmative. The clinical trial's entry on the clinicaltrials.gov registry points out that it is in search of participants, having first been posted to the page on September 1st 2023 and last updated November 27th 2023. 300 patients are required for recruitment from 10 sites."

Answered by AI

Are individuals over 80 years of age eligible to participate in this trial?

"This clinical trial stipulates that participants must be between 30 months and 99 years of age to qualify."

Answered by AI

How many participants are currently participating in this investigation?

"Indeed. Data accessible on clinicaltrials.gov affirms that this research initiative, first posted on September 1st 2023, is currently seeking volunteers. At the moment, 300 people are needed to participate at 10 distinct trial sites."

Answered by AI

Who is the ideal candidate for participating in this experiment?

"This research requires 300 young people aged between 30 months and 99 years who have a diagnosed developmental disorder. Furthermore, these participants must fulfil the inclusion criteria outlined in the study's documentation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PROmoting Early Childhood Outside 2.0
Mariana Brussoni 2023. "PROmoting Early Childhood Outside 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626595.
~115 spots leftby Oct 2024
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