Risk AssessmentNCT04624932
Early Childhood Outside (ECO) - Randomized Controlled Trial Study
A study testing RR Digital Tool and Position Statement on Active Outdoor Play in people with Risk Assessment and Online Intervention, run by University of British Columbia at 1 site in Canada.
Trial summary
Outdoor play is important for children as it can promote healthy social and physical development, emotional well-being, self-confidence, risk management and overall physical activity. Yet, opportunities for outdoor play have been decreasing across generations due to perceptions that it is dangerous and unnecessary. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Assessment, Online Intervention, Child Development
- What is being tested?
- RR Digital Tool 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
- 563 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 30 Jun 2021
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 19 years of age or older;
- Currently working or training in the early childhood education field in Canada; and,
- Being able to speak, read, and understand English.
- Having access to the internet
Who cannot join
- n/a
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: Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study
Outdoor play is important for children as it can promote healthy social and physical development, emotional well-being, self-confidence, risk management and overall physical activity. Yet, opportunities for outdoor play have been decreasing across generations due to perceptions that it is dangerous and unnecessary. Early childhood educators (ECEs) and administrators are struggling to provide children with high quality and stimulating outdoor play time. To help ECEs and administrators, the investigators have developed a Risk Reframing (RR) digital tool, https://outsideplay.ca, which is underpinned by social cognitive theory (SCT) and health behaviour change techniques.
The aim of the current study is to test the efficacy of the RR digital tool in: 1) increasing ECEs/administrators' tolerance of risk in play; and, 2) attaining their behavior change goal in promoting children's outdoor play at their early childcare center.
Read more
The investigators will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will obtain complete data on at least 206 early childhood educators and administrators currently working in Canada. The RR digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The control condition consists of reading the Position Statement on Active Outdoor Play, a 2-page information sheet on children's active outdoor play.
Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale - teacher version. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. The investigators will test the hypothesis that there will be differences between the intervention and control conditions with respect to tolerance of risk in play and goal attainment.
Read the detailed description
The study uses 2-condition (control and intervention) randomized controlled trial design.
Participants will be recruited through advertising on social media, distributing notices throughout networks, and snowball sampling. The aim is to obtain complete data on 206 participants, thus the investigators will try to recruit at least 324 ECEs and administrators at baseline to account for attrition. The investigators considered 75% and 85% retention rate at 1-week post-intervention and 3-months post-intervention, respectively. 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. Demographic questions are asked to understand the general background of participants (e.g., sex, age) and their ECE center (e.g., approximately how many staff are at their center).
They will then be randomly assigned to one of the two conditions: 1) Control condition, or, 2) Intervention condition. Neither the researchers nor participants will know in advance which condition participants will be assigned to. There is a 50% chance that they are assigned to either condition. The randomization schedule will be generated beforehand in sealedenvelop.com using blocks of size 2, 4, 6. The list will be then transferred to REDCap. Participants will not be blinded to allocation, because the nature of the intervention does not allow it. Allocation will be concealed to the researchers at participant assignment as well as data analysis.
Participants who are assigned to Control condition will be provided with a PDF version of the position statement on active outdoor play, which can take up 20 minutes to read. Then, they will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.
Participants who are assigned to Intervention condition will be automatically taken to the online tool, https://outsideplay.ca. The online tool is to reframe participants' perceptions of outdoor play and change their service delivery. It includes a series of interactive video scenarios where participants can make choices, which will result in different endings for each scenario. This can take up to 100 minutes to complete. Then participants will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.
Participants who are assigned to Control condition will have access to the online tool upon completion of their participation in the current study.
After 1-week, all participants who completed the baseline survey and the intervention (e.g., the Position Statement on Active Outdoor Play or the RR tool) will receive an email inviting them to complete a follow-up survey questionnaire. The investigators will also follow up on whether they had accomplished their goal.
After 3-months, all participants who completed the 1-week post-intervention survey will receive another email to complete the same follow-up survey questionnaire for the final time. The investigators will also follow up on whether they had accomplished their goal.
The study hypotheses are:
- Participants in Intervention condition will have a significantly greater increase of tolerance for risk in play than participants in Control condition.
- A greater proportion of participants in Intervention condition will attain their behavior change goal, than participants in Control condition.
- Conditions
- Risk Assessment, Online Intervention, Child Development
- Being tested
- RR Digital Tool, Position Statement on Active Outdoor Play
- Keywords
- Risk reframing tool, Children's outdoor play, Children's outdoor risky play, Early childhood education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR Digital ToolBehavioural
This is the intervention condition. Participants in this condition will take the RR digital tool available at https://outsideplay.ca.
Position Statement on Active Outdoor PlayBehavioural
This is the control condition. Participants in this condition will read the position statement that summarizes the issues and research regarding children's access to outdoor play.
| Study group | Role | What they receive |
|---|---|---|
| Risk Reframing (RR) Digital Tool | Experimental | Participants proceed through three chapters in the tool: https://outsideplay.ca.
Chapter 1: reflecting on their own childhood play activities; what they got out of these experiences; outdoor play activities of the children at their center; what they do to promote children's outdoor play; what gets in the way in promoting children outdoor play.
Chapter 2: imagining themselves in six video segments where they must decide how to communicate with parents; and, whether they allow children to engage in rough and tumble play, play at heights, play with tools, play at speed/mud play, and resolve conflicts amongst themselves
Chapter 3: reflecting on their barriers and things that helped them promote and support the children's outdoor play at their center. Participants to assess whether there is anything they want to change to set a realistic goal, outlining steps for attaining that goal. Receives: Behavioral: RR Digital Tool |
| Position Statement on Active Outdoor Play | Sham comparator | 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. 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 Across Baseline, 1-week Post-intervention and 3-months Post-intervention
This scale measures participants' tolerance of risk in outside play. Teacher Tolerance of Risk in Play Scale has 26 items of yes/no (coded as 1 and 0, respectively) survey questions of risk tolerance. To account for item difficulty and respondent trait, we convert respondents' responses to a psychometric measure that is standardized to z-scores. We standardized the measure to z-scores at each measurement time point. For example, at baseline, all respondents' (including those from control and intervention group) psychometric measures have a population mean of zero/0 and standard deviation of 1. A higher z-score means a higher tolerance of risk in play (in the case of our study, a higher score means a more favorable outcome). In this table, we present the outcome measures as absolute z-score values, rather than change from two time points. We do not consider clinically relevant threshold for this outcome measure as there is no established literature.
Measured: Baseline, 1-week post-intervention, and 3-months post-intervention
Secondary outcomes (1)
Change in Attainment of a Behavior Change Goal
This is a yes/no self-report question asking participants if they think they had attained their behavior change goal. Unit of measure is 'yes' or 'no' to measure incidence of behavior change goal attainment.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, and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 563 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, Principal investigator, University of British Columbia / BC Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624932
- Sponsor's protocol ID
- H19-03644
- Status last verified
- Jul 2023
- First submitted
- 30 Oct 2020
- Last updated
- 11 Jul 2023
- 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 requests.
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 26062040ParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015
Ihrig KM. Teacher tolerance of risk in play scale (T-TRiPS): Evaluating the psychometric properties of a new measure. (Unpublished master thesis). Colorado State University, Fort Collins, Colorado, USA; 2020.
Brussoni M, Han CS, Lin Y, Jacob J, Munday F, Zeni M, Walters M, Oberle E. Evaluation of the Web-Based OutsidePlay-ECE Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 10;24(6):e36826. doi: 10.2196/36826.
PubMed 35687394Brussoni M, Han CS, Jacob J, Munday F, Zeni M, Walters M, Cheng T, Schneeberg A, Fox E, Oberle E. A Web-Based Risk-Reframing Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Protocol for the OutsidePlay Study Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 18;10(11):e31041. doi: 10.2196/31041.
PubMed 34792479
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Outside (ECO) Early Childhood Educator (ECE) Tool - Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT04624932
- Acronym / sponsor ID
- H19-03644
- Conditions
- Risk Assessment, Online Intervention, Child Development
- Keywords
- Risk reframing tool, Children's outdoor play, Children's outdoor risky play, Early childhood education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Outdoor play is important for children as it can promote healthy social and physical development, emotional well-being, self-confidence, risk management and overall physical activity. Yet, opportunities for outdoor play have been decreasing across generations due to perceptions that it is dangerous and unnecessary. Early childhood educators (ECEs) and administrators are struggling to provide children with high quality and stimulating outdoor play time. To help ECEs and administrators, the investigators have developed a Risk Reframing (RR) digital tool, https://outsideplay.ca, which is underpinned by social cognitive theory (SCT) and health behaviour change techniques.
The aim of the current study is to test the efficacy of the RR digital tool in: 1) increasing ECEs/administrators' tolerance of risk in play; and, 2) attaining their behavior change goal in promoting children's outdoor play at their early childcare center.
The investigators will conduct a single-blind (researchers and outcome assessors) randomized controlled trial and will obtain complete data on at least 206 early childhood educators and administrators currently working in Canada. The RR digital tool is designed for a one-time visit and includes three chapters of self-reflection and experiential learning tasks. The control condition consists of reading the Position Statement on Active Outdoor Play, a 2-page information sheet on children's active outdoor play.
Primary outcome is increased tolerance of risk in play, as measured by the Tolerance of Risk in Play Scale - teacher version. Secondary outcome is self-reported attainment of a behaviour change goal that participants set for themselves. The investigators will test the hypothesis that there will be differences between the intervention and control conditions with respect to tolerance of risk in play and goal attainment.
Detailed description
The study uses 2-condition (control and intervention) randomized controlled trial design.
Participants will be recruited through advertising on social media, distributing notices throughout networks, and snowball sampling. The aim is to obtain complete data on 206 participants, thus the investigators will try to recruit at least 324 ECEs and administrators at baseline to account for attrition. The investigators considered 75% and 85% retention rate at 1-week post-intervention and 3-months post-intervention, respectively. 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. Demographic questions are asked to understand the general background of participants (e.g., sex, age) and their ECE center (e.g., approximately how many staff are at their center).
They will then be randomly assigned to one of the two conditions: 1) Control condition, or, 2) Intervention condition. Neither the researchers nor participants will know in advance which condition participants will be assigned to. There is a 50% chance that they are assigned to either condition. The randomization schedule will be generated beforehand in sealedenvelop.com using blocks of size 2, 4, 6. The list will be then transferred to REDCap. Participants will not be blinded to allocation, because the nature of the intervention does not allow it. Allocation will be concealed to the researchers at participant assignment as well as data analysis.
Participants who are assigned to Control condition will be provided with a PDF version of the position statement on active outdoor play, which can take up 20 minutes to read. Then, they will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.
Participants who are assigned to Intervention condition will be automatically taken to the online tool, https://outsideplay.ca. The online tool is to reframe participants' perceptions of outdoor play and change their service delivery. It includes a series of interactive video scenarios where participants can make choices, which will result in different endings for each scenario. This can take up to 100 minutes to complete. Then participants will be invited to set a goal that could help them give children at their center more opportunities for outdoor play.
Participants who are assigned to Control condition will have access to the online tool upon completion of their participation in the current study.
After 1-week, all participants who completed the baseline survey and the intervention (e.g., the Position Statement on Active Outdoor Play or the RR tool) will receive an email inviting them to complete a follow-up survey questionnaire. The investigators will also follow up on whether they had accomplished their goal.
After 3-months, all participants who completed the 1-week post-intervention survey will receive another email to complete the same follow-up survey questionnaire for the final time. The investigators will also follow up on whether they had accomplished their goal.
The study hypotheses are:
- Participants in Intervention condition will have a significantly greater increase of tolerance for risk in play than participants in Control condition.
- A greater proportion of participants in Intervention condition will attain their behavior change goal, than participants in Control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Reframing (RR) Digital Tool | Experimental | Behavioral: RR Digital ToolParticipants proceed through three chapters in the tool: https://outsideplay.ca. Chapter 1: reflecting on their own childhood play activities; what they got out of these experiences; outdoor play activities of the children at their center; what they do to promote children's outdoor play; what gets in the way in promoting children outdoor play. Chapter 2: imagining themselves in six video segments where they must decide how to communicate with parents; and, whether they allow children to engage in rough and tumble play, play at heights, play with tools, play at speed/mud play, and resolve conflicts amongst themselves Chapter 3: reflecting on their barriers and things that helped them promote and support the children's outdoor play at their center. Participants to assess whether there is anything they want to change to set a realistic goal, outlining steps for attaining that goal. |
| Position Statement on Active Outdoor Play | Sham comparator | Behavioral: 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 19 years of age or older;
- Currently working or training in the early childhood education field in Canada; and,
- Being able to speak, read, and understand English.
- Having access to the internet
Key exclusion criteria (1 listed)
- n/a
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 ToolThis is the intervention condition. Participants in this condition will take the RR digital tool available at https://outsideplay.ca. | Behavioural | Risk Reframing (RR) Digital Tool |
| Position Statement on Active Outdoor PlayThis is the control condition. Participants in this condition will read the position statement that summarizes the issues and research regarding children's access to outdoor play. | Behavioural | Position Statement on Active Outdoor Play |
Primary outcome
Change in Tolerance of Risk in Play Across Baseline, 1-week Post-intervention and 3-months Post-intervention
Time frame: Baseline, 1-week post-intervention, and 3-months post-intervention
This scale measures participants' tolerance of risk in outside play. Teacher Tolerance of Risk in Play Scale has 26 items of yes/no (coded as 1 and 0, respectively) survey questions of risk tolerance. To account for item difficulty and respondent trait, we convert respondents' responses to a psychometric measure that is standardized to z-scores. We standardized the measure to z-scores at each measurement time point. For example, at baseline, all respondents' (including those from control and intervention group) psychometric measures have a population mean of zero/0 and standard deviation of 1. A higher z-score means a higher tolerance of risk in play (in the case of our study, a higher score means a more favorable outcome). In this table, we present the outcome measures as absolute z-score values, rather than change from two time points. We do not consider clinically relevant threshold for this outcome measure as there is no established literature.
1 secondary outcome
Change in Attainment of a Behavior Change Goal
Time frame: 1-week post-intervention, and 3-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- 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.
- BackgroundParticipACTION. The Biggest Risk Is Keeping Kids Indoors: ParticipACTION Report Card on Physical Activity for Children and Youth. Toronto, Ontario; 2015
- BackgroundIhrig KM. Teacher tolerance of risk in play scale (T-TRiPS): Evaluating the psychometric properties of a new measure. (Unpublished master thesis). Colorado State University, Fort Collins, Colorado, USA; 2020.
- Derived from this study: PubMed 35687394Brussoni M, Han CS, Lin Y, Jacob J, Munday F, Zeni M, Walters M, Oberle E. Evaluation of the Web-Based OutsidePlay-ECE Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 10;24(6):e36826. doi: 10.2196/36826.
- Derived from this study: PubMed 34792479Brussoni M, Han CS, Jacob J, Munday F, Zeni M, Walters M, Cheng T, Schneeberg A, Fox E, Oberle E. A Web-Based Risk-Reframing Intervention to Influence Early Childhood Educators' Attitudes and Supportive Behaviors Toward Outdoor Play: Protocol for the OutsidePlay Study Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 18;10(11):e31041. doi: 10.2196/31041.
- Individual participant dataSharing planned: Yes. The data set will be available from Dr. Brussoni upon reasonable requests.
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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 principal investigator
University of British Columbia / BC Children's Hospital
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 and Position Statement on Active Outdoor Play in people with Risk Assessment and Online Intervention, 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 4 inclusion and 1 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 11 Jul 2023. 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 11 Jul 2023). 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 Across Baseline, 1-week Post-intervention and 3-months Post-intervention (time frame: Baseline, 1-week post-intervention, and 3-months 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 NCT04624932, which also lists 5 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 11 Jul 2023.