NCT03374683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 28, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

December 6, 2017

Results QC Date

April 27, 2021

Last Update Submit

June 24, 2021

Conditions

Keywords

Risky playPhysical activityInjury preventionOutdoor play

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 1-week-post-intervention, 3-month-post-intervention

Secondary Outcomes (1)

  • Self-reported Behaviour Change

    1-week-post-intervention, 3-month-post-intervention

Study Arms (3)

RR Digital Tool

EXPERIMENTAL

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

RR In-Person Workshop

ACTIVE COMPARATOR

Participants in the in-person workshop attended the 45-90 minute in-person workshop.

Behavioral: RR In-Person Workshop

Position Statement on Active Outdoor Play

SHAM COMPARATOR

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

Interventions

RR Digital ToolBEHAVIORAL

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.

RR Digital Tool

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.

RR In-Person Workshop

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).

Position Statement on Active Outdoor Play

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant self-identifies as mother.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital Research Institute

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (6)

  • 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.

    PMID: 26062040BACKGROUND
  • Sandseter EB. Characteristics of risky play. J Adventure Educ Outdoor Learn. 2009;9(1):3-21. doi:10.1080/14729670802702762.

    BACKGROUND
  • 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.

    PMID: 22846064BACKGROUND
  • ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015.

    BACKGROUND
  • 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.

    PMID: 29514699BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Given the nature of the interventions, it was not possible to blind participants to their allocation, thus potentially introducing sources of bias.

Results Point of Contact

Title
Dr. Mariana Brussoni
Organization
University of British Columbia

Study Officials

  • Mariana Brussoni, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 15, 2017

Study Start

December 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 28, 2021

Results First Posted

June 28, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations