Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play

Parenting Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parenting
• Risk Assessment

• NCT number: NCT03374683
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Completion date: September 30, 2018