Clinical trial NCT04624932: Early Childhood Outside (ECO) - Randomized Controlled Trial Study
Official title: Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Assessment
Online Intervention
Child Development
Keywords: Risk reframing tool
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: 2020-11-12
Enrollment: 563
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

n/a

Primary outcomes:
measure: Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention
timeFrame: Baseline, 1-week post-intervention, and 3-months post-intervention
Secondary outcomes:
measure: Change in Attainment of a Behavior Change Goal
timeFrame: 1-week post-intervention, and 3-months post-intervention
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia / BC Children's Hospital
name: Mariana Brussoni
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tremblay MS, Gray C, Babcock S, Barnes J, Bradstreet CC, Carr D, Chabot G, Choquette L, Chorney D, Collyer C, Herrington S, Janson K, Janssen I, Larouche R, Pickett W, Power M, Sandseter EB, Simon B, Brussoni M. Position Statement on Active Outdoor Play. Int J Environ Res Public Health. 2015 Jun 8;12(6):6475-505. doi: 10.3390/ijerph120606475.
citation: ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015
citation: Ihrig KM. Teacher tolerance of risk in play scale (T-TRiPS): Evaluating the psychometric properties of a new measure. (Unpublished master thesis). Colorado State University, Fort Collins, Colorado, USA; 2020.
citation: Brussoni M, Han CS, Lin Y, Jacob J, Munday F, Zeni M, Walters M, Oberle E. Evaluation of the Web-Based OutsidePlay-ECE Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 10;24(6):e36826. doi: 10.2196/36826.
citation: Brussoni M, Han CS, Jacob J, Munday F, Zeni M, Walters M, Cheng T, Schneeberg A, Fox E, Oberle E. A Web-Based Risk-Reframing Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Protocol for the OutsidePlay Study Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 18;10(11):e31041. doi: 10.2196/31041.