Trial Outcomes & Findings for Early Childhood Outside (ECO) - Randomized Controlled Trial Study (NCT NCT04624932)
NCT ID: NCT04624932
Last Updated: 2023-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
563 participants
Primary outcome timeframe
Baseline, 1-week post-intervention, and 3-months post-intervention
Results posted on
2023-07-11
Participant Flow
We recruited participants between December 1, 2020 to March 15, 2021 via social media posts - FaceBook, FaceBook Ads, Twitter and Instagram - and mass email through partner and professional networks.
Eligible participants provided consent by downloading the consent form and selecting a checkbox to participate. Enrolled participants completed the baseline survey (demographic, and, a questionnaire on tolerance for risk in play, self-efficacy, and stage of change) and entered their email addresses. Then, we automatically randomized enrolled participants in the REDCap to one of the two conditions: intervention and control. Participants had an equal likelihood of being assigned to each condition.
Participant milestones
| Measure |
Position Statement on Active Outdoor Play
Position Statement 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.
|
Risk Reframing (RR) Digital Tool
RR Digital Tool: This is the intervention condition. Participants in this condition completed the RR digital tool available at 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.
|
|---|---|---|
|
Overall Study
STARTED
|
282
|
281
|
|
Overall Study
1-week Post-intervention
|
209
|
126
|
|
Overall Study
COMPLETED
|
195
|
119
|
|
Overall Study
NOT COMPLETED
|
87
|
162
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Position Statement on Active Outdoor Play
n=282 Participants
Position Statement 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 (ParticipACTION Canada, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
n=281 Participants
RR Digital Tool: This is the intervention condition. Participants in this condition completed the RR digital tool available at 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.
|
Total
n=563 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
19-24 years
|
26 Participants
n=282 Participants
|
33 Participants
n=281 Participants
|
59 Participants
n=563 Participants
|
|
Age, Customized
25-30 years
|
72 Participants
n=282 Participants
|
55 Participants
n=281 Participants
|
127 Participants
n=563 Participants
|
|
Age, Customized
31-40 years
|
71 Participants
n=282 Participants
|
86 Participants
n=281 Participants
|
157 Participants
n=563 Participants
|
|
Age, Customized
41-50 years
|
66 Participants
n=282 Participants
|
64 Participants
n=281 Participants
|
130 Participants
n=563 Participants
|
|
Age, Customized
51 years and older
|
46 Participants
n=282 Participants
|
42 Participants
n=281 Participants
|
88 Participants
n=563 Participants
|
|
Age, Customized
Participant did not provide answer
|
1 Participants
n=282 Participants
|
1 Participants
n=281 Participants
|
2 Participants
n=563 Participants
|
|
Sex/Gender, Customized
Female
|
272 Participants
n=282 Participants
|
272 Participants
n=281 Participants
|
544 Participants
n=563 Participants
|
|
Sex/Gender, Customized
Non-female
|
10 Participants
n=282 Participants
|
9 Participants
n=281 Participants
|
19 Participants
n=563 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada · British Columbia
|
129 Participants
n=282 Participants
|
129 Participants
n=281 Participants
|
258 Participants
n=563 Participants
|
|
Region of Enrollment
Canada · New Brunswick
|
52 Participants
n=282 Participants
|
44 Participants
n=281 Participants
|
96 Participants
n=563 Participants
|
|
Region of Enrollment
Canada · Ontario
|
64 Participants
n=282 Participants
|
66 Participants
n=281 Participants
|
130 Participants
n=563 Participants
|
|
Region of Enrollment
Canada · Others
|
36 Participants
n=282 Participants
|
40 Participants
n=281 Participants
|
76 Participants
n=563 Participants
|
|
Region of Enrollment
Canada · Participant did not provide answer
|
1 Participants
n=282 Participants
|
2 Participants
n=281 Participants
|
3 Participants
n=563 Participants
|
|
Language
English
|
263 Participants
n=282 Participants
|
261 Participants
n=281 Participants
|
524 Participants
n=563 Participants
|
|
Language
Others
|
19 Participants
n=282 Participants
|
20 Participants
n=281 Participants
|
39 Participants
n=563 Participants
|
|
Role
Early childhood educator (ECE)
|
203 Participants
n=282 Participants
|
189 Participants
n=281 Participants
|
392 Participants
n=563 Participants
|
|
Role
ECE administrator
|
75 Participants
n=282 Participants
|
90 Participants
n=281 Participants
|
165 Participants
n=563 Participants
|
|
Role
Others
|
4 Participants
n=282 Participants
|
2 Participants
n=281 Participants
|
6 Participants
n=563 Participants
|
|
Years working in the field
|
10.22 years
STANDARD_DEVIATION 9.51 • n=282 Participants
|
10.05 years
STANDARD_DEVIATION 9.16 • n=281 Participants
|
10.14 years
STANDARD_DEVIATION 9.33 • n=563 Participants
|
|
Years working at the current center
|
6.09 years
STANDARD_DEVIATION 7.41 • n=282 Participants
|
5.18 years
STANDARD_DEVIATION 5.98 • n=281 Participants
|
5.63 years
STANDARD_DEVIATION 6.74 • n=563 Participants
|
|
Whether the center is licensed
Yes
|
266 Participants
n=282 Participants
|
264 Participants
n=281 Participants
|
530 Participants
n=563 Participants
|
|
Whether the center is licensed
No
|
7 Participants
n=282 Participants
|
7 Participants
n=281 Participants
|
14 Participants
n=563 Participants
|
|
Whether the center is licensed
Participant did not provide answer
|
9 Participants
n=282 Participants
|
10 Participants
n=281 Participants
|
19 Participants
n=563 Participants
|
|
Number of children at the center
Small: 1-24
|
91 Participants
n=282 Participants
|
95 Participants
n=281 Participants
|
186 Participants
n=563 Participants
|
|
Number of children at the center
Medium: 25-48
|
76 Participants
n=282 Participants
|
78 Participants
n=281 Participants
|
154 Participants
n=563 Participants
|
|
Number of children at the center
Large: >= 49
|
111 Participants
n=282 Participants
|
106 Participants
n=281 Participants
|
217 Participants
n=563 Participants
|
|
Number of children at the center
Participant did not provide answer
|
4 Participants
n=282 Participants
|
2 Participants
n=281 Participants
|
6 Participants
n=563 Participants
|
|
Number of staffs at the center
Small: 1-5
|
100 Participants
n=282 Participants
|
102 Participants
n=281 Participants
|
202 Participants
n=563 Participants
|
|
Number of staffs at the center
Medium: 6-12
|
85 Participants
n=282 Participants
|
91 Participants
n=281 Participants
|
176 Participants
n=563 Participants
|
|
Number of staffs at the center
Large: >= 13
|
91 Participants
n=282 Participants
|
82 Participants
n=281 Participants
|
173 Participants
n=563 Participants
|
|
Number of staffs at the center
Participant did not provide answer
|
6 Participants
n=282 Participants
|
6 Participants
n=281 Participants
|
12 Participants
n=563 Participants
|
|
Whether the center has a designated outdoor space for children
Yes
|
270 Participants
n=282 Participants
|
270 Participants
n=281 Participants
|
540 Participants
n=563 Participants
|
|
Whether the center has a designated outdoor space for children
No
|
8 Participants
n=282 Participants
|
9 Participants
n=281 Participants
|
17 Participants
n=563 Participants
|
|
Whether the center has a designated outdoor space for children
Participant did not provide answer
|
4 Participants
n=282 Participants
|
2 Participants
n=281 Participants
|
6 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Very good
|
96 Participants
n=282 Participants
|
88 Participants
n=281 Participants
|
184 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Good
|
95 Participants
n=282 Participants
|
110 Participants
n=281 Participants
|
205 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Acceptable
|
65 Participants
n=282 Participants
|
60 Participants
n=281 Participants
|
125 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Poor
|
12 Participants
n=282 Participants
|
11 Participants
n=281 Participants
|
23 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Very poor
|
2 Participants
n=282 Participants
|
0 Participants
n=281 Participants
|
2 Participants
n=563 Participants
|
|
Quality of the center's outdoor space for children
Participant did not provide answer
|
12 Participants
n=282 Participants
|
12 Participants
n=281 Participants
|
24 Participants
n=563 Participants
|
|
Hours children spent playing outdoors at the center
|
2.01 hours
STANDARD_DEVIATION 1.15 • n=282 Participants
|
2.14 hours
STANDARD_DEVIATION 1.13 • n=281 Participants
|
2.08 hours
STANDARD_DEVIATION 1.14 • n=563 Participants
|
|
Feeling supported by colleagues in general
Yes
|
251 Participants
n=282 Participants
|
250 Participants
n=281 Participants
|
501 Participants
n=563 Participants
|
|
Feeling supported by colleagues in general
No or others
|
31 Participants
n=282 Participants
|
27 Participants
n=281 Participants
|
58 Participants
n=563 Participants
|
|
Feeling supported by colleagues in general
Participant did not provide answer
|
0 Participants
n=282 Participants
|
4 Participants
n=281 Participants
|
4 Participants
n=563 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-week post-intervention, and 3-months post-interventionPopulation: A total of 563 participants with baseline demographic and other survey data completed was included at baseline. Of 563 participants, 282 were randomized to the control group and 281 to the intervention group. At 1-week post-intervention, 335 participants were included; and at 3-month post-intervention, 314 participants were included in the analysis.
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.
Outcome measures
| Measure |
Position Statement on Active Outdoor Play
n=282 Participants
Position Statement 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 (ParticipACTION Canada, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
n=281 Participants
RR Digital Tool: This is the intervention condition. Participants in this condition completed the RR digital tool available at 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.
|
|---|---|---|
|
Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention
Baseline outcome
|
0.040 score on a scale
Standard Deviation 1.207
|
-0.040 score on a scale
Standard Deviation 1.243
|
|
Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention
1-week post-intervention
|
-0.156 score on a scale
Standard Deviation 1.304
|
0.262 score on a scale
Standard Deviation 1.117
|
|
Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention
3-month post-intervention
|
-0.118 score on a scale
Standard Deviation 1.400
|
0.200 score on a scale
Standard Deviation 1.211
|
SECONDARY outcome
Timeframe: 1-week post-intervention, and 3-months post-interventionPopulation: We included 335 participants with complete secondary outcome data (goal) at 1-week post-intervention, and 314 participants at 3-month 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.
Outcome measures
| Measure |
Position Statement on Active Outdoor Play
n=209 Participants
Position Statement 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 (ParticipACTION Canada, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
n=126 Participants
RR Digital Tool: This is the intervention condition. Participants in this condition completed the RR digital tool available at 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.
|
|---|---|---|
|
Change in Attainment of a Behavior Change Goal
1-week post-intervention · Yes
|
141 Participants
|
94 Participants
|
|
Change in Attainment of a Behavior Change Goal
1-week post-intervention · No
|
68 Participants
|
32 Participants
|
|
Change in Attainment of a Behavior Change Goal
3-months post-intervention · Yes
|
163 Participants
|
106 Participants
|
|
Change in Attainment of a Behavior Change Goal
3-months post-intervention · No
|
32 Participants
|
13 Participants
|
Adverse Events
Position Statement on Active Outdoor Play
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Risk Reframing (RR) Digital Tool
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place