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

June 24, 2021 updated by: Mariana Brussoni, University of British Columbia

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.

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.

ACTIVE_COMPARATOR: RR In-Person Workshop
Participants in the in-person workshop attended the 45-90 minute 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.
SHAM_COMPARATOR: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tolerance of Risk in Play Scale (TRiPS)
Time Frame: 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.
Baseline, 1-week-post-intervention, 3-month-post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Behaviour Change
Time Frame: 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.
1-week-post-intervention, 3-month-post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mariana Brussoni, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H15-03271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data set will be available from Dr. Brussoni upon reasonable request.

IPD Sharing Time Frame

Starting upon publication of the RCT results until five years after publication.

IPD Sharing Access Criteria

Dr. Brussoni will review requests and share supporting information as indicated above with researchers and students doing similar research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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