Trial Outcomes & Findings for Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play (NCT NCT03374683)
NCT ID: NCT03374683
Last Updated: 2021-06-28
Results Overview
The primary outcome measure was increase in the total score on the Tolerance for Risk in Play Scale (TRiPS), a 31-item measure examining adults' tolerance of risk during children's play. This analysis was conducted using mirt package in R software (Chalmers, 2012). Rasch analysis of the baseline data resulted in dropping one item ("Do you allow this child to play-fight, testing who is strongest?") due to local dependence. Theta standardized scores from the Rasch analysis of the final 30-item TRiPS total scale ranged from -3.372 to 1.975, with a mean of 0.000 (SD 0.974). A higher standardized score indicates higher tolerance of risky outdoor play.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
451 participants
Primary outcome timeframe
Baseline, 1-week-post-intervention, 3-month-post-intervention
Results posted on
2021-06-28
Participant Flow
Participants were recruited through advertising on online forums and social media, distributing notices through our networks, snowball sampling and posting notices in community centers. Recruitments were active from December 2017 to May 2018 in the Metro Vancouver area.
Participants were randomized to a condition when they were deemed eligible. After being randomized, participants received the socio-demographic questionnaire and the intervention. A total of 451 participants who completed the socio-demographic questionnaire were included in the study.
Participant milestones
| Measure |
Position Statement 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 (ParticipACTION Canada, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.
Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.
Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date.
|
RR In-Person Workshop
RR In-Person Workshop: Participants engage in a 2-hour facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
148
|
150
|
153
|
|
Overall Study
1-week Post-intervention
|
135
|
113
|
85
|
|
Overall Study
COMPLETED
|
123
|
105
|
84
|
|
Overall Study
NOT COMPLETED
|
25
|
45
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play
Baseline characteristics by cohort
| Measure |
Position Statement on Active Outdoor Play
n=148 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=150 Participants
RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.
Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.
Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date.
|
RR In-Person Workshop
n=153 Participants
RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
40.8 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
40.29 years
STANDARD_DEVIATION 5.51 • n=7 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
451 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Population groups · White
|
101 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
330 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Population groups · Other
|
47 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Marital status
Married/Common-law
|
118 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
374 Participants
n=7 Participants
|
|
Marital status
Other
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
|
Education
< university / college
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Education
University / college
|
66 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
218 Participants
n=7 Participants
|
|
Education
> university college
|
46 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
|
Education
Missed data
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Employment
Employed for wages/self employed
|
115 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
266 Participants
n=7 Participants
|
|
Employment
Unemployed
|
33 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
185 Participants
n=7 Participants
|
|
Home dwelling
Single-detached
|
69 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
218 Participants
n=7 Participants
|
|
Home dwelling
Others
|
79 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
233 Participants
n=7 Participants
|
|
Income
< $63,300
|
36 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
|
Income
$63,300-$103,299
|
49 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
139 Participants
n=7 Participants
|
|
Income
>=$103,300
|
52 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
161 Participants
n=7 Participants
|
|
Income
Prefer not to answer
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Exposure to risky play information
No
|
126 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
365 Participants
n=7 Participants
|
|
Exposure to risky play information
Yes
|
22 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
Child age
|
8.4 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
8.1 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
8.0 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
8.1 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
|
Child sex
Boy
|
85 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
252 Participants
n=7 Participants
|
|
Child sex
Girl
|
60 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
195 Participants
n=7 Participants
|
|
Child sex
Missing data
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Child's disability/chronic condition
No
|
143 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
431 Participants
n=7 Participants
|
|
Child's disability/chronic condition
Yes
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Outdoor time
Weekday
|
3.0 hours
STANDARD_DEVIATION 3.6 • n=99 Participants
|
2.8 hours
STANDARD_DEVIATION 3.2 • n=107 Participants
|
2.6 hours
STANDARD_DEVIATION 2.8 • n=206 Participants
|
2.80 hours
STANDARD_DEVIATION 3.20 • n=7 Participants
|
|
Outdoor time
Weekend
|
2.7 hours
STANDARD_DEVIATION 2.2 • n=99 Participants
|
2.8 hours
STANDARD_DEVIATION 2.0 • n=107 Participants
|
2.9 hours
STANDARD_DEVIATION 2.8 • n=206 Participants
|
2.79 hours
STANDARD_DEVIATION 2.36 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-week-post-intervention, 3-month-post-interventionPopulation: Included was 451 mothers with baseline demographic data; and, 351 mothers with baseline outcome data (TRiPS) at baseline, 333 mothers at 1-week-post-intervention, and 312 mothers at 3-month-post-intervention.
The primary outcome measure was increase in the total score on the Tolerance for Risk in Play Scale (TRiPS), a 31-item measure examining adults' tolerance of risk during children's play. This analysis was conducted using mirt package in R software (Chalmers, 2012). Rasch analysis of the baseline data resulted in dropping one item ("Do you allow this child to play-fight, testing who is strongest?") due to local dependence. Theta standardized scores from the Rasch analysis of the final 30-item TRiPS total scale ranged from -3.372 to 1.975, with a mean of 0.000 (SD 0.974). A higher standardized score indicates higher tolerance of risky outdoor play.
Outcome measures
| Measure |
Position Statement on Active Outdoor Play
n=148 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, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
n=150 Participants
RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.
Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.
Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date.
|
RR In-Person Workshop
n=153 Participants
RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
|
|---|---|---|---|
|
Change in Tolerance of Risk in Play Scale (TRiPS)
3-month-post-intervention outcome
|
-0.03 score on a scale
Standard Deviation 0.92
|
-0.09 score on a scale
Standard Deviation 0.93
|
0.15 score on a scale
Standard Deviation 0.80
|
|
Change in Tolerance of Risk in Play Scale (TRiPS)
Baseline outcome
|
0.05 score on a scale
Standard Deviation 1.03
|
-0.14 score on a scale
Standard Deviation 0.97
|
0.18 score on a scale
Standard Deviation 0.87
|
|
Change in Tolerance of Risk in Play Scale (TRiPS)
1-week-post-intervention outcome
|
-0.09 score on a scale
Standard Deviation 1.03
|
-0.06 score on a scale
Standard Deviation 1.05
|
0.22 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 1-week-post-intervention, 3-month-post-interventionPopulation: Included was 333 mothers with complete secondary outcome data (Goal) at 1-week post-intervention - which represents the first time we collected these data; and 312 mothers at 3-month-post intervention.
The secondary outcome measure was self-reported behavior change, measured by participants' self-reported progress on attaining the goal they set for themselves within the risk reframing intervention. At each follow-up, participants were reminded of their goal (by asking "at the beginning of the study, you set a goal for yourself regarding something you wanted to change to give your child more opportunities for risky play. Have you made progress toward this goal?") and asked "Did you accomplish your goal?" with "Yes" and "No" response options. 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=135 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, 2015; Tremblay et al., 2015).
|
Risk Reframing (RR) Digital Tool
n=113 Participants
RR Digital Tool: Participants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.
Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.
Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date.
|
RR In-Person Workshop
n=85 Participants
RR In-Person Workshop: Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
|
|---|---|---|---|
|
Self-reported Behaviour Change
3-month-post-intervention participants who responded · Yes
|
99 Participants
|
90 Participants
|
62 Participants
|
|
Self-reported Behaviour Change
1-week-post-intervention participants who responded · Yes
|
76 Participants
|
81 Participants
|
47 Participants
|
|
Self-reported Behaviour Change
1-week-post-intervention participants who responded · No
|
59 Participants
|
32 Participants
|
38 Participants
|
|
Self-reported Behaviour Change
3-month-post-intervention participants who responded · No
|
24 Participants
|
15 Participants
|
22 Participants
|
Adverse Events
Risk Reframing (RR) Digital Tool
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RR In-Person Workshop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Position Statement on Active Outdoor Play
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