Early Childhood Outside (ECO) - Randomized Controlled Trial Study

• ClinicalTrials.gov Identifier: NCT04624932
• Recruitment Status: Recruiting
• First Posted: November 12, 2020
• Last Update Posted: April 28, 2021
• Sponsor: University of British Columbia
• Collaborator: The Lawson Foundation
• Information provided by (Responsible Party): Mariana Brussoni, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Risk Assessment; Online Intervention; Child Development	Behavioral: RR Digital Tool; Behavioral: Position Statement on Active Outdoor Play	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Allocations will be concealed to the researchers at participant assignment and data analysis.
• Primary Purpose: Treatment
• Official Title: Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: July 31, 2021
• Estimated Study Completion Date: July 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Risk Reframing (RR) Digital Tool; Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: reflecting on their own childhood play activities; what they got out of these experiences; outdoor play activities of the children at their center; what they do to promote children's outdoor play; what gets in the way in promoting children outdoor play. Chapter 2: imagining themselves in six video segments where they must decide how to communicate with parents; and, whether they allow children to engage in rough and tumble play, play at heights, play with tools, play at speed/mud play, and resolve conflicts amongst themselves Chapter 3: reflecting on their barriers and things that helped them promote and support the children's outdoor play at their center. Participants to assess whether there is anything they want to change to set a realistic goal, outlining steps for attaining that goal.	Behavioral: RR Digital Tool; This is the intervention condition. Participants in this condition will take the RR digital tool available at https://outsideplay.ca.
Sham Comparator: Position Statement on Active Outdoor Play; The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that "access to active play in nature and outdoors - with its risks - is essential for healthy child development" and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety.	Behavioral: Position Statement on Active Outdoor Play; 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.

Outcome Measures

Primary Outcome Measures :

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 participant changing tolerance of risk in play. Teacher Tolerance of Risk in Play Scale is a 26-item yes/no survey question of risk tolerance; minimum = 0 and maximum = 26; higher scores mean a higher tolerance of risk in play

Secondary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Mariana Brussoni; 604-875-3712; mbrussoni@bcchr.ubc.ca

Contact: Christina Han; 604-875-2000 ext 5078; chan@bcchr.ca

Locations

Canada, British Columbia

British Columbia Children's Hospital Research Institute; Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contact: Mariana Brussoni, PhD 604-875-3712 mbrussoni@bcchr.ubc.ca

Contact: Christina Han 604-875-2000 ext 5078 chan@bcchr.ca

Principal Investigator: Mariana Brussoni, PhD

Sub-Investigator: Louise Masse, PhD

Sponsors and Collaborators

University of British Columbia

The Lawson Foundation

Investigators

• Principal Investigator: Mariana Brussoni; University of British Columbia / BC Children's Hospital

More Information

Publications:

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. Review.

ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mariana Brussoni, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT04624932
• Other Study ID Numbers: H19-03644
• First Posted: November 12, 2020
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data set will be available from Dr. Brussoni upon reasonable requests.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Starting upon publication of the RCT results until five years after publication.
• Access Criteria: Dr. Brussoni will review requests and share supporting information as indicated above with researchers and students going similar research.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mariana Brussoni, University of British Columbia:

Risk reframing tool; Children's outdoor play; Children's outdoor risky play; Early childhood education