An interventional study of RR Digital Tool and RR In-Person Workshop in Risk Assessment and Parenting, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-28.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
Among 96 studies in Motor Activity by University of British Columbia — 24 open to participants now, 26 under way, none of them phase 3. Motor Activity · University of British Columbia.
Among the 96 studies in Motor Activity by University of British Columbia, this one is the 8th largest by enrollment of the 92 interventional ones that give a count, is one of 5 that started in 2017, is one of 88 with no phase, and was the 43rd registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →24 of the 96 studies in Motor Activity by University of British Columbia are open now, in 1 country. Recruiting first, the newest first:
University of British Columbia · Sites in Canada
Ages 19–79 · Healthy volunteers
University of British Columbia · Sites in Canada
Ages 50+
University of British Columbia · Sites in Canada
Ages 19–35 · Healthy volunteers
University of British Columbia · Sites in Canada
Ages up to 99
University of British Columbia · Sites in Canada
Ages 19–39 · Healthy volunteers
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
96 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 451 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 61 across the 92 interventional studies, 35 across the 4 observational. Of the 58 that completed or were terminated, 12 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
11 of the studies in Motor Activity by University of British Columbia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07717710University of British ColumbiaIvabradine for Heart Rate Reduction During Exercise in Healthy Adults | 2026-12 |
| NCT06195423University of British ColumbiaStopping OsteoARthritis After an ACL Tear | 2026-12-30 |
| NCT07443293University of British ColumbiaIMPACT 360 for Parkinson's Disease | 2026-12-31 |
| NCT04299945University of British ColumbiaEffects of Drinking Beetroot Juice on Exercise Performance in Patients With Fibrotic Interstitial Lung Disease | 2026-12-31 |
| NCT07212712University of British ColumbiaThe Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans | 2026-12-31 |
Among the 96 studies in Motor Activity by University of British Columbia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Children's risky play is associated with a variety of positive developmental, physical and mental health outcomes, including greater physical activity, self-confidence and risk management skills. Children's opportunities for risky play have eroded over time, limited by parents' fears and beliefs about risk, particularly among mothers. We have developed a digital and in-person workshop version of a tool to reframe parents' perceptions of risk. We examined whether the tool increased mothers' tolerance for risky play and influenced parenting behaviour change, in the short and long term, and whether these changes were greater than those in the control group.
We conducted a single-blind (researchers and outcome assessors) randomized controlled trial and recruited a total of 410 mothers of children aged 6-12 years. The risk reframing (RR) digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The RR in-person tool is a 45-90 minute facilitated workshop in which participants were guided through discussions of the same tasks contained within the digital tool. The control condition consisted of reading the Position Statement on Active Outdoor Play.
Primary outcome was increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale. Secondary outcome was self-reported attainment of a behaviour change goal that participants had set for themselves. We tested the hypothesis that there would be differences between the experimental and control groups with respect to tolerance of risk in play and goal attainment.
The study used 3-group parallel randomized controlled trial design.
Participants were recruited through advertising on social media, distributing notices through our networks, snowball sampling, and posting notices in community centres. The aim was to obtain complete data on 375 participants. Interested participants completed 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 received a link to the baseline questionnaire package to be completed in REDcap.
Once participants were deemed eligible for the study, they were allocated to one of the three conditions: 1) Control group; 2) RR digital tool; and 3) RR in-person workshop. Participants in Condition 1 were provided with a link to the Position Statement on Active Outdoor Play, which included information on research and recommendations for action. Participants in Condition 2 were provided with a link to the RR digital tool to complete at their leisure. Participants in Condition 3, were scheduled to attend the RR in-person workshop. The randomization schedule was generated beforehand in sealedenvelop.com using blocks of size 3, 6, and 9. The list was then transferred to REDCap.
Honoraria were paid at each time point as compensation for participation. Participants attending in-person RR workshops were provided with an additional honorarium to compensate them for any expenses incurred in attending, such as travel or childcare.
Participants had an equal likelihood of assignment to each condition (33%). The nature of the intervention did not permit participant blinding but they were informed of their allocated treatment after completing the baseline questionnaires. The in-person workshop facilitator could not be blinded to allocation as the other two arms did not have a facilitator. Likewise, research staff who coordinated in-person workshop schedules could not be blinded to the allocation of the in-person workshop. However, allocations were concealed to the researchers at participant assignment and data analysis.
Participants completed a questionnaire package at three time points: Baseline, 1-week post-intervention, and 3-months post-intervention. Survey data were collected and managed using REDCap.
The study hypotheses were:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the RR digital tool were provided with a link to the web-based intervention (https://outsideplay.ca) to complete within one week.
Behavioral: RR Digital Tool
Participants in the in-person workshop attended the 45-90 minute in-person workshop.
Behavioral: RR In-Person Workshop
Participants in the control condition were provided with a web link to the Position Statement on Active Outdoor Play, which includes information on research and recommendations for action.
Behavioral: Position Statement on Active Outdoor Play
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.
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.
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).
Change in Tolerance of Risk in Play Scale (TRiPS)
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.
Time frame: Baseline, 1-week-post-intervention, 3-month-post-intervention
Self-reported Behaviour Change
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.
Time frame: 1-week-post-intervention, 3-month-post-intervention
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.
| Milestone | Position Statement Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop |
|---|---|---|---|
| Started | 148 | 150 | 153 |
| 1-week post-intervention | 135 | 113 | 85 |
| Completed | 123 | 105 | 84 |
| Not completed | 25 | 45 | 69 |
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.
| score on a scale | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop |
|---|---|---|---|
| Baseline outcome | 0.05 ± 1.03 | -0.14 ± 0.97 | 0.18 ± 0.87 |
| 1-week-post-intervention outcome | -0.09 ± 1.03 | -0.06 ± 1.05 | 0.22 ± 0.80 |
| 3-month-post-intervention outcome | -0.03 ± 0.92 | -0.09 ± 0.93 | 0.15 ± 0.80 |
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.
| Participants | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop |
|---|---|---|---|
| 1-week-post-intervention participants who responded — Yes | 76 | 81 | 47 |
| 1-week-post-intervention participants who responded — No | 59 | 32 | 38 |
| 3-month-post-intervention participants who responded — Yes | 99 | 90 | 62 |
| 3-month-post-intervention participants who responded — No | 24 | 15 | 22 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Risk Reframing (RR) Digital Tool | — | — | — |
| RR In-Person Workshop | — | — | — |
| Position Statement on Active Outdoor Play | — | — | — |
| Age, Continuous(years) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Mean | 40.7 ± 5.3 | 40.8 ± 5.5 | 39.6 ± 5.0 | 40.29 ± 5.51 |
| Sex: Female, Male(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Female | 148 | 150 | 153 | 451 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Population groups — White | 101 | 112 | 117 | 330 |
| Population groups — Other | 47 | 38 | 36 | 121 |
| Marital status(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Married/Common-law | 118 | 125 | 131 | 374 |
| Other | 30 | 25 | 22 | 77 |
| Education(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| < university / college | 36 | 36 | 33 | 105 |
| University / college | 66 | 80 | 72 | 218 |
| > university college | 46 | 32 | 46 | 124 |
| Missed data | 0 | 2 | 2 | 4 |
| Employment(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Employed for wages/self employed | 115 | 107 | 44 | 266 |
| Unemployed | 33 | 43 | 109 | 185 |
| Home dwelling(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| Single-detached | 69 | 77 | 72 | 218 |
| Others | 79 | 73 | 81 | 233 |
| Income(Participants) | Position Statement on Active Outdoor Play | Risk Reframing (RR) Digital Tool | RR In-Person Workshop | Total |
|---|---|---|---|---|
| < $63,300 | 36 | 40 | 33 | 109 |
| $63,300-$103,299 | 49 | 40 | 50 | 139 |
| >=$103,300 | 52 | 54 | 55 | 161 |
| Prefer not to answer | 11 | 16 | 15 | 42 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data set will be available from Dr. Brussoni upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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 doing similar research.
Ran from Dec 2017 to primary completion in Sep 2018, 9 months.
Results were first posted in Jun 2021, 2 years 8 months after primary completion.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 9 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of British Columbia →