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Completed

NCT Number: NCT04624932

Early Childhood Outside (ECO) - Randomized Controlled Trial Study

Outdoor play is important for children as it can promote healthy social and physical development, emotional well-being, self-confidence, risk management and overall physical activity. Yet, opportunities for outdoor play have been decreasing across generations due to perceptions that it is dangerous and unnecessary. Early childhood educators (ECEs) and administrators are struggling to provide children with high quality and stimulating outdoor play time. To help ECEs and administrators, the investigators have developed a Risk Reframing (RR) digital tool, https://outsideplay.ca, which is underpinned by social cognitive theory (SCT) and health behaviour change techniques.

The aim of the current study is to test the efficacy of the RR digital tool in: 1) increasing ECEs/administrators' tolerance of risk in play; and, 2) attaining their behavior change goal in promoting children's outdoor play at their early childcare center.

The investigators will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will obtain complete data on at least 206 early childhood educators and administrators currently working in Canada. The RR digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The control condition consists of reading the Position Statement on Active Outdoor Play, a 2-page information sheet on children's active outdoor play.

Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale - teacher version. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. The investigators will test the hypothesis that there will be differences between the intervention and control conditions with respect to tolerance of risk in play and goal attainment.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital Research Institute

Vancouver, British Columbia, V6H 3V4, Canada

About this study

The study uses 2-condition (control and intervention) randomized controlled trial design.

Participants will be recruited through advertising on social media, distributing notices throughout networks, and snowball sampling. The aim is to obtain complete data on 206 participants, thus the investigators will try to recruit at least 324 ECEs and administrators at baseline to account for attrition. The investigators considered 75% and 85% retention rate at 1-week post-intervention and 3-months post-intervention, respectively. Interested participants will complete a questionnaire in REDCap electronic data capture tool hosted at British Columbia Children's Hospital Research Institute to answer eligibility questions and provide informed consent. Enrolled participants will be sent a link to the baseline questionnaire package to be completed in REDcap. Demographic questions are asked to understand the general background of participants (e.g., sex, age) and their ECE center (e.g., approximately how many staff are at their center).

They will then be randomly assigned to one of the two conditions: 1) Control condition, or, 2) Intervention condition. Neither the researchers nor participants will know in advance which condition participants will be assigned to. There is a 50% chance that they are assigned to either condition. The randomization schedule will be generated beforehand in sealedenvelop.com using blocks of size 2, 4, 6. The list will be then transferred to REDCap. Participants will not be blinded to allocation, because the nature of the intervention does not allow it. Allocation will be concealed to the researchers at participant assignment as well as data analysis.

Participants who are assigned to Control condition will be provided with a PDF version of the position statement on active outdoor play, which can take up 20 minutes to read. Then, they will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.

Participants who are assigned to Intervention condition will be automatically taken to the online tool, https://outsideplay.ca. The online tool is to reframe participants' perceptions of outdoor play and change their service delivery. It includes a series of interactive video scenarios where participants can make choices, which will result in different endings for each scenario. This can take up to 100 minutes to complete. Then participants will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.

Participants who are assigned to Control condition will have access to the online tool upon completion of their participation in the current study.

After 1-week, all participants who completed the baseline survey and the intervention (e.g., the Position Statement on Active Outdoor Play or the RR tool) will receive an email inviting them to complete a follow-up survey questionnaire. The investigators will also follow up on whether they had accomplished their goal.

After 3-months, all participants who completed the 1-week post-intervention survey will receive another email to complete the same follow-up survey questionnaire for the final time. The investigators will also follow up on whether they had accomplished their goal.

The study hypotheses are:

  • Participants in Intervention condition will have a significantly greater increase of tolerance for risk in play than participants in Control condition.
  • A greater proportion of participants in Intervention condition will attain their behavior change goal, than participants in Control condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 19 years of age or older;
  • Currently working or training in the early childhood education field in Canada; and,
  • Being able to speak, read, and understand English.
  • Having access to the internet

Exclusion criteria

n/a

Treatment and study plan

RR Digital Tool

Behavioral

This is the intervention condition. Participants in this condition will take the RR digital tool available at https://outsideplay.ca.

Position Statement on Active Outdoor Play

Behavioral

This is the control condition. Participants in this condition will read the position statement that summarizes the issues and research regarding children's access to outdoor play.

Primary outcomes

  1. Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention

    Time frame: Baseline, 1-week post-intervention, and 3-months post-intervention

    This scale measures participants' tolerance of risk in outside play. Teacher Tolerance of Risk in Play Scale has 26 items of yes/no (coded as 1 and 0, respectively) survey questions of risk tolerance. To account for item difficulty and respondent trait, we convert respondents' responses to a psychometric measure that is standardized to z-scores. We standardized the measure to z-scores at each measurement time point. For example, at baseline, all respondents' (including those from control and intervention group) psychometric measures have a population mean of zero/0 and standard deviation of 1. A higher z-score means a higher tolerance of risk in play (in the case of our study, a higher score means a more favorable outcome). In this table, we present the outcome measures as absolute z-score values, rather than change from two time points. We do not consider clinically relevant threshold for this outcome measure as there is no established literature.

Secondary outcomes

  1. Change in Attainment of a Behavior Change Goal

    Time frame: 1-week post-intervention, and 3-months post-intervention

    This is a yes/no self-report question asking participants if they think they had attained their behavior change goal. Unit of measure is 'yes' or 'no' to measure incidence of behavior change goal attainment.For the purpose of our analyses the category of "Yes" is an indication of behaviour change while the category of "No" is an indication of no behaviour change.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • The Lawson Foundation

Registry information

Official study title

Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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