Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study
Phase: NA
Conditions: Risk Assessment, Online Intervention, Child Development
Sponsor: University of British Columbia

 
Official title: Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - 
Randomized Controlled Trial Study 
 
 
 
NCT number: NCT04624932 
 
 
Document date: July 28, 2022 
 
 
 
Document type: Study Protocol with 
Statistical Analysis Plan 
 
 

Study Protocol 
Objectives 
Our study objective is to develop and evaluate a web-based intervention that influences early 
childhood educators’ (ECEs) and early learning child care (ELCC) administrators’ perceptions 
and practices in support of children’s outdoor play in ELCCs. 
 
Design 
This study is guided by the 6-step Intervention Mapping process (Michie et al., 2008) to plan, 
develop and evaluate the web-based intervention as described in Objectives. Upon receiving 
ethics approval from the University of British Columbia and Children’s and Women’s Health 
Centre of British Columbia Research Ethics Board (H19-01230; H19-03644), we began with Step 
1 to understand the problem. This was done by establishing and working with study partners from 
various disciplines; and, conducting a literature review and a need assessment of the target 
population through focus groups – to explore key issues, needs and challenges from different 
perspectives. A logic model of the problem was developed to establish intervention goals. Step 2 
involved developing a logic model of change to identify what needs to change and for whom. This 
linked the behavioral and environmental change objectives to specific outcomes that helped meet 
the intervention objectives. Then we selected the optimal applications and technology to deliver 
the intervention (Step 3) to produce the intervention (Step 4). In Step 5, we developed the 
intervention implementation and mobilization plan to make sure this web-based intervention 
reaches the target audiences. For the final step (Step 6), we will conduct a single-blind 
randomized control trial to test the efficacy of the web-based intervention.  
 
Methods 
We used a single-blind (researchers and outcome assessors), two-parallel-group randomized 
controlled trial design to evaluate the efficacy of the intervention. Consenting, randomization, 
survey administration and follow-ups was managed strictly online. We recruited 563 ECEs and 
ELCC administrators at baseline through a variety of online means, including Facebooks Ads and 
mass emails through our partner networks. Participants were randomized into the intervention or 
the control group by the REDCap, an electronic data capture intervention, hosted by the BC 
Children’s Hospital Research Institute. Participants had equal likelihood of assignment to each 
group using a basic randomization method. The control group read Position Statement on Active 
Outdoor Play, a 4-page document on research and recommendations for action in addressing 
barriers to outdoor play (Tremblay et al., 2015). The intervention group fook the web-based 
intervention to influence ECEs and ELCC administrators’ perceptions and practices in support of 
children’s outdoor play in ELCCs.  
 
The primary outcome is increased tolerance of risk in children’s play, as measured by the Teacher 
Tolerance of Risk in Play Scale. The secondary outcome is self-reported attainment of a self-
developed behavior change goal at either two follow-up time point. 
 
For complete study protocol, refer to: 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 Research Protocols; 
2021;10(11):e31041. [doi: 10.2196/31041] 
 

Statistical Analysis Plan 
 
Statistical software 
The latest version of R (R Foundation for Statistical Computing, Vienna, Austria) and Stata 
(StataCorp LLC, College Station, TX, USA) was used for statistical analysis and graphics. 
 
Power 
For a sample size of 206 ECEs and ELCC administrators in total, a linear mixed model examining 
the impact of intervention relative to control, including an interaction with time, was calculated to 
have 80% power at a P=.05 level of significance to detect a difference of 0.75 between the 
intervention and control conditions on the T-TRiPS when the SD is 1.82, and the correlation 
between repeated observations is 0.75. From our previous work (Brussoni et al., 2021), we 
anticipated requiring 324 complete baseline requirements among ECEs and ELCC administrators 
who would then be randomized into the 2 conditions. We assumed a 75% retention rate at the 1-
week postintervention follow-up time point (n=242) and an 85% retention rate at our 3-month 
postintervention follow-up time point, which would result in a final sample of 206 ECEs, 
corresponding to 103 in each condition. 
 
Measurement occasions and follow-ups 
Participants completed a questionnaire package at three time points: baseline (T1), 1-week post-
intervention (T2) and 3-month post-intervention (T3). Long-term change is unlikely if participants 
do not make initial changes, thus, the 1-week follow-up was selected to assess short- term 
effectiveness, while still providing participants sufficient time to make their initial planned 
changes. The 3-month follow-up assessed long-term effectiveness once participants have had 
several months to reflect on the intervention and implement change. Survey data were collected 
and managed using REDCap. Baseline data collection includes socio-demographic data: sex, age, 
ethnicity, spoken language, years working in the early learning childcare field, years working in 
the current ELCC center, role in the current ELCC center, province of employment, whether the 
center is licensed, number of children at the center, number of staffs at the center, whether the 
center has a designated outdoor space for children, quality of the center’s outdoor space for 
children, hours children spent playing outdoors at the center, and whether the participant feels 
supported by colleagues in general. 
 
We assessed the primary outcome measure at baseline, 1-week, and 3-month post-intervention. We 
could only assess the secondary outcome measure at 1-week and 3-month post-intervention 
because at baseline participants could not have accomplished a goal they had not yet set.  
 
Outcome measures 
Our primary outcome measure is change in the total score on the Teacher Tolerance of Risk in Play 
Scale (T-TRiPS), a validated, reliable 26-item measure with dichotomous yes/no responses on 
items that reflect Sandseter’s (Sandseter, 2009) six categories of risky play (great heights, high 
speed, dangerous tools, dangerous elements, rough-and-tumble, disappear/get lost) (Ihrig, 2020). 
The T-TRiPS is a modified version of the TRiPS for parents (Hill & Bundy, 2014) measuring 
teachers’ perception of risk. We assessed the psychometric properties of T-TRiPs in our sample 
using Rasch analysis, using mirt package in R software (Chalmers, 2012). Items with local 
dependence will be dropped and model fit amongst the remaining items will be assessed: root 
mean square error of approximation, standardized root mean square residual, Tucker–Lewis index, 
comparative fit index, and empirical reliability. Theta standardized scores will be obtained for the 
analysis and a higher standardized score indicates higher tolerance of risk in play. 
Our secondary outcome measure is self-reported behavior change, measured by participants’ self-
reported progress on attaining the goal they set for themselves. At each follow-up time point, 

participants will be reminded of their goal and asked “Did you accomplish your goal?” with 
dichotomous yes/no responses.  
 
Descriptive Analysis 
To compare the raw outcome differences between conditions at each time point, for continuous 
outcomes (TRiPS scores), we used 1-way ANOVA or Kruskal-Wallis H test (if variance is not 
equal between conditions). For categorical outcomes (goal attainment), we used the chi-square test. 
Significance level was set at P=.05. 
 
 
For complete results, refer to: 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. JMIR; 2022; 24(6):e36826. [doi: 10.2196/36826] 
 
 
References 
Brussoni, M., Han, C. S., Lin, Y., Jacob, J., Pike, I., Bundy, A., … Mâsse, L. (2021). A web-based 
and in-person risk reframing intervention to influence mothers’ tolerance for, and parenting 
practices associated with, children’s outdoor risky play: Randomized controlled trial. Journal 
of Medical Internet Research, 23(4), e24861. https://doi.org/10.2196/24861 
Chalmers, R. P. (2012). mirt: A Multidimensional Item Response Theory Package for the R 
Environment. Journal of Statistical Software, 48(6), 1–29. 
https://doi.org/10.18637/jss.v048.i06 
Hill, A., & Bundy, A. C. (2014). Reliability and validity of a new instrument to measure tolerance 
of everyday risk for children. Child: Care, Health and Development, 40(1), 68–76. 
https://doi.org/10.1111/j.1365-2214.2012.01414.x 
Ihrig, K. (2020). Teacher Tolerance of Risk in Play Scale (T-TRiPS): Evaluating the Psychometric 
Properties of a New Measure. Colorado State University. 
Michie, S., Johnston, M., Francis, J., Hardeman, W., Eccles, M. (2008). From Theory to 
Intervention: Mapping Theoretically Derived Behavioural Determinants to Behaviour Change 
Techniques. Journal of Applied Psychology, 57(4):660–80.  
Sandseter, E. B. H. (2009). Characteristics of risky play. Journal of Adventure Education & 
Outdoor Learning, 9(1), 3–21. https://doi.org/10.1080/14729670802702762 
Singer, J., & Willet, J. (2003). Applied longitudinal analysis. New York: Oxford University Press 
Inc. 
Tremblay, M.S., Gray, C., Babcock, S., Barnes, J., Bradstreet, C.C., Carr, D., Chabot, G., 
Choquette, L., Chorney, D., Collyer, C., Herrington, S., Janson, K., Janssen, I., Larouche, R., 
Pickett, W., Power, M., Sandseter, E.B.H., Simon, B., Brussoni, M. (2015). Position 
Statement on Active Outdoor Play. International Journal of Environmental Research and 
Public Health, 12(6), 6475–6505.