ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 4772 for:    British | Canada

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03374683
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Mariana Brussoni, 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 will examine whether the tool increases mothers' tolerance for risky play and influences parenting behaviour change, in the short and long term, and whether these changes are greater than those in the control group.

We will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will recruit at total of 501 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 2-hour facilitated workshop in which participants are guided through discussion of the same tasks contained within the digital tool. The control condition consists of reading the Position Statement on Active Outdoor Play.

Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. We will test the hypothesis that there will be differences between the experimental and control groups with respect to tolerance of risk in play and goal attainment.


Condition or disease Intervention/treatment Phase
Risk Assessment Parenting Behavioral: RR Digital Tool Behavioral: RR In-Person Workshop Behavioral: Position Statement Active Outdoor Play Not Applicable

Detailed Description:

The study uses 3-group parallel randomized controlled trial design.

Participants will be recruited through advertising on social media, distributing notices through our networks, snowball sampling, and posting notices in community centres. The aim is to obtain complete data on 375 participants, thus the investigators will recruit at least 501 mothers to account for attrition. Interested participants will complete 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 will be sent a link to the baseline questionnaire package to be completed in REDcap.

Once participants are deemed eligible for the study, they are allocated to one of the three conditions: 1) Control group; 2) RR digital tool; and 3) RR in-person workshop. Participants in Condition 1 will be provided with a link to the Position Statement on Active Outdoor Play, which includes information on research and recommendations for action. Participants in Condition 2 will be provided with a link to the RR digital tool to complete at their leisure. Participants in Condition 3, will be 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 will be paid at each time point as compensation for participation. Participants attending in-person RR workshops are provided with an additional honorarium to compensate them for any expenses incurred in attending, such as travel or childcare.

Participants have equal likelihood of assignment to each condition (33%). They will not be blinded to allocation, because the nature of the intervention does not allow it. They will be informed of their allocated treatment after completing the baseline questionnaires. Allocation will be concealed to the researchers at participant assignment and data analysis. Furthermore, the RR in-person workshop facilitator does not need to be blinded to allocation, as the other two arms do not have a facilitator.

Participants will complete a questionnaire package at three time points: Baseline (T1), 1-week post-intervention (T2), and 3-months post-intervention (T3). Survey data will be collected and managed using REDCap.

The study hypotheses are:

  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  (Clinical Trial)
Estimated Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Risk Reframing (RR) Digital Tool Behavioral: RR Digital Tool

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 Behavioral: RR In-Person Workshop
Participants engage in a 2-hour 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 Active Outdoor Play Behavioral: Position Statement Active Outdoor Play
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).




Primary Outcome Measures :
  1. Change in Tolerance of Risk in Play Scale (TRiPS) [ Time Frame: Before intervention, 1 week post-intervention, 3 months post-intervention ]
    A 31-item measure examining adults' tolerance of risk during children's play (Hill & Bundy, 2014). The scale is based on Sandseter's six-category model of risky play (Sandseter, 2009). Goodness of fit statistics for TRiPS have been found to be in the acceptable range (Hill & Bundy, 2014). Item hierarchy examination indicated that items that were relatively difficult to endorse (e.g., "Would you let the child play near the edge of steep cliffs?") were located higher on than those that were easier to endorse (e.g., "Would you let the child play in the backyard supervised?"). The person separation index was 2.63, indicating that the measure separated persons into more than two distinct groups, such as more and less risk-tolerant. The person reliability index was 0.87 indicating that the instrument was able to consistently differentiate between those scoring high versus low.


Secondary Outcome Measures :
  1. Self-reported behaviour change [ Time Frame: 1 week post-intervention, 3 months post-intervention ]
    Parents' self-reported progress on attaining the goal they set for themselves within the RR tool. Participants are asked: "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?" with response options "Yes," "No," and "I've attained the goal." For the purpose of our analyses the categories "Yes" and "I've attained the goal" will be combined to indicate behaviour change.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant self-identifies as mother.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374683


Contacts
Contact: Takuro Ishikawa, MSc 1-888-300-3088 ext 6708 tishikawa@bcchr.ca
Contact: Christina Han, MA 1-888-300-3088 ext 5078 chan@bcchr.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital Research Institute Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Mariana Brussoni, PhD    604-875-3712    mbrussoni@bcchr.ubc.ca   
Contact: Christina Han    604-875-2000 ext 5078    chan@bcchr.ca   
Principal Investigator: Mariana Brussoni, PhD         
Sub-Investigator: Louise Masse, PhD         
Sponsors and Collaborators
University of British Columbia
The Lawson Foundation
Investigators
Principal Investigator: Mariana Brussoni, PhD University of British Columbia

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mariana Brussoni, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03374683     History of Changes
Other Study ID Numbers: H15-03271
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data set will be available from Dr. Brussoni upon reasonable request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mariana Brussoni, University of British Columbia:
Risky play
Physical activity
Injury prevention
Outdoor play