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

Not Applicable

Completed

• Conditions: Risk Assessment; Parenting
• Interventions: Behavioral: RR Digital Tool; Behavioral: RR In-Person Workshop; Behavioral: Position Statement on Active Outdoor Play

• Registration Number: NCT03374683
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2021-04-27
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Results First Posted: 2021-06-28
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 451

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RR Digital Tool	RR Digital Tool	Participants in the RR digital tool were provided with a link to the web-based intervention (https://outsideplay.ca) to complete within one week.
RR In-Person Workshop	RR In-Person Workshop	Participants in the in-person workshop attended the 45-90 minute in-person workshop.
Position Statement on Active Outdoor Play	Position Statement on Active Outdoor Play	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.

Primary Outcome Measures

Name	Time	Method
Change in Tolerance of Risk in Play Scale (TRiPS)	Baseline, 1-week-post-intervention, 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.

Secondary Outcome Measures

Name	Time	Method
Self-reported Behaviour Change	1-week-post-intervention, 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.

Trial Locations

Locations (1)

British Columbia Children's Hospital Research Institute; 🇨🇦 Vancouver, British Columbia, Canada