Risk AssessmentNCT03374683
Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play
A study testing RR Digital Tool, RR In-Person Workshop and Position Statement on Active Outdoor Play in people with Risk Assessment and Parenting, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Assessment, Parenting
- What is being tested?
- RR Digital Tool, RR In-Person Workshop and Position Statement on Active Outdoor Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital Research Institute
Vancouver, British Columbia, V6H 3V4
About this study
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
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.
Read the 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:
- Mothers completing the RR digital tool will have a significantly greater increase of tolerance for risk in play than mothers in the control condition.
- 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.
- A greater proportion of mothers completing the RR digital tool will attain their behaviour change goal, than mothers in the control condition.
- A greater proportion of mothers completing the RR in-person workshop will attain their behaviour change goal than mothers in the control condition.
- Conditions
- Risk Assessment, Parenting
- Being tested
- RR Digital Tool, RR In-Person Workshop, Position Statement on Active Outdoor Play
- Keywords
- Risky play, Physical activity, Injury prevention, Outdoor play
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR Digital ToolBehavioural
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 In-Person WorkshopBehavioural
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.
Position Statement on Active Outdoor PlayBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: RR Digital Tool |
| RR In-Person Workshop | Active comparator | Participants in the in-person workshop attended the 45-90 minute in-person workshop. Receives: 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. Receives: Behavioral: Position Statement on Active Outdoor Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-week-post-intervention, 3-month-post-intervention
Secondary outcomes (1)
Self-reported Behaviour Change
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.
Measured: 1-week-post-intervention, 3-month-post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Risk AssessmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Lawson Foundation
- Responsible party
- Principal investigator, Mariana Brussoni, University of British Columbia
- Investigators
- Mariana Brussoni, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374683
- Sponsor's protocol ID
- H15-03271
- Status last verified
- Jun 2021
- First submitted
- 6 Dec 2017
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data set will be available from Dr. Brussoni upon reasonable request.
Publications
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.
PubMed 26062040Sandseter EB. Characteristics of risky play. J Adventure Educ Outdoor Learn. 2009;9(1):3-21. doi:10.1080/14729670802702762.
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.
PubMed 22846064ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015.
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.
PubMed 29514699Brussoni 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.
PubMed 33904820
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03374683
- Acronym / sponsor ID
- H15-03271
- Conditions
- Risk Assessment, Parenting
- Keywords
- Risky play, Physical activity, Injury prevention, Outdoor play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 28 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Mothers completing the RR digital tool will have a significantly greater increase of tolerance for risk in play than mothers in the control condition.
- 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.
- A greater proportion of mothers completing the RR digital tool will attain their behaviour change goal, than mothers in the control condition.
- A greater proportion of mothers completing the RR in-person workshop will attain their behaviour change goal than mothers in the control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RR Digital Tool | Experimental | Behavioral: RR Digital ToolParticipants 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 | Active comparator | Behavioral: RR In-Person WorkshopParticipants in the in-person workshop attended the 45-90 minute in-person workshop. |
| Position Statement on Active Outdoor Play | Sham comparator | Behavioral: Position Statement on Active Outdoor PlayParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RR Digital ToolParticipants 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. | Behavioural | RR Digital Tool |
| RR In-Person WorkshopParticipants 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. | Behavioural | RR In-Person Workshop |
| Position Statement on Active Outdoor PlayThe 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). | Behavioural | Position Statement on Active Outdoor Play |
Primary outcome
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.
1 secondary outcome
Self-reported Behaviour Change
Time frame: 1-week-post-intervention, 3-month-post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26062040Tremblay 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.
- BackgroundSandseter EB. Characteristics of risky play. J Adventure Educ Outdoor Learn. 2009;9(1):3-21. doi:10.1080/14729670802702762.
- Background: PubMed 22846064Hill 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.
- BackgroundParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015.
- Background: PubMed 29514699Brussoni 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.
- Results publication: PubMed 33904820Brussoni 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.
- Canadian Position Statement on Active Outdoor PlayLink provided by the sponsor.
- Risk Reframing Digital ToolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data set will be available from Dr. Brussoni upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Brussoni, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RR Digital Tool, RR In-Person Workshop and Position Statement on Active Outdoor Play in people with Risk Assessment and Parenting, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tolerance of Risk in Play Scale (TRiPS) (time frame: Baseline, 1-week-post-intervention, 3-month-post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374683, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.