Clinical trial NCT03374683: Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play
Official title: Go Play Outside! Effects of a Risk Reframing Tool on Mothers' Tolerance for and Parenting Practices Associated With Children's Risky Play - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Assessment
Parenting
Keywords: Risky play
Physical activity
Injury prevention
Outdoor play
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2017-12-15
Enrollment: 451
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1. Mothers completing the RR digital tool will have a significantly greater increase of tolerance for risk in play than mothers in the control condition.
2. Mothers completing the RR in-person workshop will have a significantly greater increase of tolerance for risk in play than mothers in the control condition.
3. A greater proportion of mothers completing the RR digital tool will attain their behaviour change goal, than mothers in the control condition.
4. A greater proportion of mothers completing the RR in-person workshop will attain their behaviour change goal than mothers in the control condition.

Eligibility criteria: Inclusion Criteria:

* Being a mother with primary custody of a child/children aged 6-12 years
* Residing in the Metro Vancouver Regional District
* Being able to speak, read and understand English

Exclusion Criteria:

* Being a father
* Not having a child between the ages of 6-12 years
* Not having primary custody of the child
* Not residing in Metro Vancouver Regional District
* Limited English skills

Primary outcomes:
measure: Change in Tolerance of Risk in Play Scale (TRiPS)
timeFrame: Baseline, 1-week-post-intervention, 3-month-post-intervention
Secondary outcomes:
measure: Self-reported Behaviour Change
timeFrame: 1-week-post-intervention, 3-month-post-intervention
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mariana Brussoni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sandseter EB. Characteristics of risky play. J Adventure Educ Outdoor Learn. 2009;9(1):3-21. doi:10.1080/14729670802702762.
citation: Hill A, Bundy AC. Reliability and validity of a new instrument to measure tolerance of everyday risk for children. Child Care Health Dev. 2014 Jan;40(1):68-76. doi: 10.1111/j.1365-2214.2012.01414.x. Epub 2012 Jul 30.
citation: ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015.
citation: Brussoni M, Ishikawa T, Han C, Pike I, Bundy A, Faulkner G, Masse LC. Go Play Outside! Effects of a risk-reframing tool on mothers' tolerance for, and parenting practices associated with, children's risky play: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):173. doi: 10.1186/s13063-018-2552-4.
citation: Brussoni M, Han CS, Lin Y, Jacob J, Pike I, Bundy A, Faulkner G, Gardy J, Fisher B, Masse L. 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. J Med Internet Res. 2021 Apr 27;23(4):e24861. doi: 10.2196/24861.