Concussion, BrainNCT04122274
Comparing and Interactive Concussion Education Platform to Current Education Standards
A study testing NCAA education sheet and Decision-based interactive concussive education platform in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to evaluate the effectiveness of a theory- driven education platform to improve concussion-related norms and perceptions in an effort to improve student-athletes concussion-related decision-making. Participants: 80 college-aged recreational athletes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- NCAA education sheet and Decision-based interactive concussive education platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 21 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rostered club sport and/or recreational athletes at a single institution will be recruited for participation in this study.
Who cannot join
- There are no additional exclusion criteria for rostered club and intramural athletes at the study institution
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparing and Interactive Concussion Education Platform to Current Education Standards: A Randomized Control Trial
Purpose: The purpose of this study is to evaluate the effectiveness of a theory- driven education platform to improve concussion-related norms and perceptions in an effort to improve student-athletes concussion-related decision-making.
Participants: 80 college-aged recreational athletes.
Procedures: The study is a single-blind (participants) randomized control trial where participants will complete a previously validated survey assessing concussion knowledge, perceived norms, attitudes, and behavioral intentions immediately pre- and post-receipt of their designated intervention. Participants will also complete the previously validated survey two-week post receipt of their designated intervention. The interventions include an interactive concussion education platform along with the NCAA (National Collegiate Athletic Association) concussion education sheet and the NCAA concussion education sheet alone (with a sham educational intervention similar in length to the concussion education platform).
Read the detailed description
A convenience sample of participants will be recruited from the University of North Carolina at Chapel Hill student-body from November-January via campus emails, in-class recruitment, flyers/informational sheets, and word of mouth from fellow participants. During the beginning of recruitment, efforts were targeted towards males with participant numbers being carefully monitored. Recruitment will be targeted to recruit an even number of males and females. Interested participants will be contacted to confirm interest and those who remained interested will be scheduled to complete the study session. Participants will report to an on-campus athletic training facility or research laboratory or may report/complete study activities virtually.
Participants will then complete the written, informed consent process. The consent form indicated that they would be completing a sport-related educational intervention to not disclose the information they would receive and to keep participants blind to their intervention group assignment. Participants will not be explicitly told that it is a study evaluating concussion education, but rather an injury and nutrition study, to reduce bias. Once the consent form was signed, participants were assigned a unique identifier and randomized (simple) without replacement to one of the two study arms, using a pre-determined random number generator in Excel. Participants then completed the pre- questionnaire in a quiet location via a tablet/computer provided by the research team or virtually. There was no time limit for completion of the questionnaire. The survey will feature an item that prompts individuals if they miss a question, but does not force participants to respond. After initial questionnaire completion, participants completed their assigned intervention (decision-based interactive concussion education platform + NCAA concussion education sheet versus NCAA education sheet). Immediately following their respective intervention, athletes completed the questionnaire again. Upon completing the post-intervention questionnaire, the participant's participation in the study is complete and they will receive an incentive. Following each survey, a research team member will verify and assess for missing answers, allowing participants to complete any missed questions that they wish to answer. Two weeks following the post-intervention survey, participants will be contacted again to complete the same questionnaire to assess retention of concussion knowledge, perceived norms, attitudes, and behavioral intentions. At this two-week post time point, participants will be informed of the true purpose of the study and be provided access to the BANK (Behaviors, Attitudes, Norms, and Knowledge) platform.
- Conditions
- Concussion, Brain
- Being tested
- NCAA education sheet, Sham Intervention, Decision-based interactive concussive education platform
- Keywords
- Concussion, Education
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCAA education sheetBehavioural
A fact sheet that includes information about basic signs and symptoms of a concussion as well as steps to take if an individual sustains a concussion and reinforces the need to report the injury.
Sham InterventionBehavioural
An approximately 7-minute video that includes information about basic sports nutrition facts.
Decision-based interactive concussive education platformBehavioural
A platform grounded in theoretical frameworks including the socioecological model and theory of planned behavior. It includes a short video to provide an overview of key lessons, a short quiz, and additional resource links that conclude the module.
| Study group | Role | What they receive |
|---|---|---|
| Education Sheet and Sham Intervention | Sham comparator | Participants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of the sham intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually. Receives: Behavioral: NCAA education sheet; Behavioral: Decision-based interactive concussive education platform |
| Education Sheet and Decision-based interactive intervention | Experimental | Participants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of a decision- based interactive concussion education platform intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually. Receives: Behavioral: NCAA education sheet; Behavioral: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Behavioral Norms Change Score
Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. The difference between the intervention and post-intervention total score is calculated to compute a change score.Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher scores indicate more favorable perceived norms.
Measured: From pre to post intervention, an approximate total of up to thirty minutes.
Behavioral Intention Change Score
Participants are asked a three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The difference between the pre-intervention and post-intervention score is calculated to compute a change score.Scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood that an individual will disclose concussion-like symptoms.
Measured: From pre to post intervention, an approximate total of up to thirty minutes.
Secondary outcomes (14)
Pre-Intervention Concussion Knowledge Score
Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs \& symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall concussion knowledge score. Scoring scale ranges from a minimum of 0 to a maximum 39, where a higher score indicated better concussion knowledge.
Measured: Within approximately 15 minutes prior to viewing intervention
Pre-intervention Perceived Behavioral Norms Score
Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum 49, where high scores indicate more favorable perceived norms.
Measured: Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Attitudes Score
Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure).Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.
Measured: Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Behavioral Intention Score
Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. Scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood to disclose concussion-like symptoms.
Measured: Within approximately 15 minutes prior to viewing intervention
Post-Intervention Concussion Knowledge Score
Participants are asked thirty-nine questions on a previously validated BANK survey concerning information regarding signs \& symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The scoring scale ranges from a minimum of 0 to a maximum of 39, where a higher score indicates better concussion knowledge.
Measured: Up to approximately 30 minutes after viewing intervention
Post-intervention Perceived Behavioral Norms Score
Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum of 49, where a higher score indicates more favorable perceived norms.
Measured: Up to approximately 30 minutes after viewing intervention
Post-Intervention Attitudes Score
Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where a higher score indicates more favorable attitudes.
Measured: Up to approximately 30 minutes after viewing intervention
Post-Intervention Behavioral Intention Score
Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood that the individual will disclose concussion-like symptoms.
Measured: Up to approximately 30 minutes after viewing intervention
Concussion Knowledge Change Score
Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs \& symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The difference between the pre-intervention and post-intervention total score is calculated to compute a change score. Scoring scale ranges from a minimum of 0 to a maximum of 39, where higher scores indicate better concussion knowledge.
Measured: From pre to post intervention, an approximate total of up to thirty minutes.
Attitudes Change Score
Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. The difference between the pre-intervention and post-intervention total score is calculated to compute a change score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.
Measured: From pre to post intervention, an approximate total of up to thirty minutes.
Concussion Knowledge Retention Score
Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs \& symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The scoring scale ranges from a minimum of 0 to a maximum of 39, where higher scores indicate better concussion knowledge.
Measured: Within approximately 2 weeks following the viewing of the intervention
Perceived Behavioral Norms Retention Score
Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher schools indicate more positive perceived norms.
Measured: Within approximately 2 weeks following the viewing of the intervention
Attitudes Retention Score
Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. The scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.
Measured: Within approximately 2 weeks following the viewing of the intervention
Behavioral Intention Retention Score
Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The scoring scale ranges from a minimum of 3 to a maximum 21, where a higher score indicates a better likelihood that an individual will disclose concussion-like symptoms.
Measured: Within approximately 2 weeks following the viewing of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start21 Oct 2019
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johna K Register-Mihalik, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122274
- Sponsor's protocol ID
- 19-1633
- Status last verified
- Apr 2022
- First submitted
- 8 Oct 2019
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing and Interactive Concussion Education Platform to Current Education Standards: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04122274
- Acronym / sponsor ID
- 19-1633
- Conditions
- Concussion, Brain
- Keywords
- Concussion, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of this study is to evaluate the effectiveness of a theory- driven education platform to improve concussion-related norms and perceptions in an effort to improve student-athletes concussion-related decision-making.
Participants: 80 college-aged recreational athletes.
Procedures: The study is a single-blind (participants) randomized control trial where participants will complete a previously validated survey assessing concussion knowledge, perceived norms, attitudes, and behavioral intentions immediately pre- and post-receipt of their designated intervention. Participants will also complete the previously validated survey two-week post receipt of their designated intervention. The interventions include an interactive concussion education platform along with the NCAA (National Collegiate Athletic Association) concussion education sheet and the NCAA concussion education sheet alone (with a sham educational intervention similar in length to the concussion education platform).
Detailed description
A convenience sample of participants will be recruited from the University of North Carolina at Chapel Hill student-body from November-January via campus emails, in-class recruitment, flyers/informational sheets, and word of mouth from fellow participants. During the beginning of recruitment, efforts were targeted towards males with participant numbers being carefully monitored. Recruitment will be targeted to recruit an even number of males and females. Interested participants will be contacted to confirm interest and those who remained interested will be scheduled to complete the study session. Participants will report to an on-campus athletic training facility or research laboratory or may report/complete study activities virtually.
Participants will then complete the written, informed consent process. The consent form indicated that they would be completing a sport-related educational intervention to not disclose the information they would receive and to keep participants blind to their intervention group assignment. Participants will not be explicitly told that it is a study evaluating concussion education, but rather an injury and nutrition study, to reduce bias. Once the consent form was signed, participants were assigned a unique identifier and randomized (simple) without replacement to one of the two study arms, using a pre-determined random number generator in Excel. Participants then completed the pre- questionnaire in a quiet location via a tablet/computer provided by the research team or virtually. There was no time limit for completion of the questionnaire. The survey will feature an item that prompts individuals if they miss a question, but does not force participants to respond. After initial questionnaire completion, participants completed their assigned intervention (decision-based interactive concussion education platform + NCAA concussion education sheet versus NCAA education sheet). Immediately following their respective intervention, athletes completed the questionnaire again. Upon completing the post-intervention questionnaire, the participant's participation in the study is complete and they will receive an incentive. Following each survey, a research team member will verify and assess for missing answers, allowing participants to complete any missed questions that they wish to answer. Two weeks following the post-intervention survey, participants will be contacted again to complete the same questionnaire to assess retention of concussion knowledge, perceived norms, attitudes, and behavioral intentions. At this two-week post time point, participants will be informed of the true purpose of the study and be provided access to the BANK (Behaviors, Attitudes, Norms, and Knowledge) platform.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Sheet and Sham Intervention | Sham comparator | Behavioral: NCAA education sheet, Behavioral: Decision-based interactive concussive education platformParticipants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of the sham intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually. |
| Education Sheet and Decision-based interactive intervention | Experimental | Behavioral: NCAA education sheet, Behavioral: Sham InterventionParticipants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of a decision- based interactive concussion education platform intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rostered club sport and/or recreational athletes at a single institution will be recruited for participation in this study.
Key exclusion criteria (1 listed)
- There are no additional exclusion criteria for rostered club and intramural athletes at the study institution
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 |
|---|---|---|
| NCAA education sheetA fact sheet that includes information about basic signs and symptoms of a concussion as well as steps to take if an individual sustains a concussion and reinforces the need to report the injury. | Behavioural | Education Sheet and Decision-based interactive intervention, Education Sheet and Sham Intervention |
| Sham InterventionAn approximately 7-minute video that includes information about basic sports nutrition facts. | Behavioural | Education Sheet and Decision-based interactive intervention |
| Decision-based interactive concussive education platformA platform grounded in theoretical frameworks including the socioecological model and theory of planned behavior. It includes a short video to provide an overview of key lessons, a short quiz, and additional resource links that conclude the module. | Behavioural | Education Sheet and Sham Intervention |
Primary outcome
Perceived Behavioral Norms Change Score
Time frame: From pre to post intervention, an approximate total of up to thirty minutes.
Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. The difference between the intervention and post-intervention total score is calculated to compute a change score.Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher scores indicate more favorable perceived norms.
Behavioral Intention Change Score
Time frame: From pre to post intervention, an approximate total of up to thirty minutes.
Participants are asked a three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The difference between the pre-intervention and post-intervention score is calculated to compute a change score.Scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood that an individual will disclose concussion-like symptoms.
14 secondary outcomes
Pre-Intervention Concussion Knowledge Score
Time frame: Within approximately 15 minutes prior to viewing intervention
Pre-intervention Perceived Behavioral Norms Score
Time frame: Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Attitudes Score
Time frame: Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Behavioral Intention Score
Time frame: Within approximately 15 minutes prior to viewing intervention
Post-Intervention Concussion Knowledge Score
Time frame: Up to approximately 30 minutes after viewing intervention
Post-intervention Perceived Behavioral Norms Score
Time frame: Up to approximately 30 minutes after viewing intervention
Post-Intervention Attitudes Score
Time frame: Up to approximately 30 minutes after viewing intervention
Post-Intervention Behavioral Intention Score
Time frame: Up to approximately 30 minutes after viewing intervention
Concussion Knowledge Change Score
Time frame: From pre to post intervention, an approximate total of up to thirty minutes.
Attitudes Change Score
Time frame: From pre to post intervention, an approximate total of up to thirty minutes.
Concussion Knowledge Retention Score
Time frame: Within approximately 2 weeks following the viewing of the intervention
Perceived Behavioral Norms Retention Score
Time frame: Within approximately 2 weeks following the viewing of the intervention
Attitudes Retention Score
Time frame: Within approximately 2 weeks following the viewing of the intervention
Behavioral Intention Retention Score
Time frame: Within approximately 2 weeks following the viewing of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Johna K Register-Mihalik, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NCAA education sheet and Decision-based interactive concussive education platform in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 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 17 Nov 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Behavioral Norms Change Score (time frame: From pre to post intervention, an approximate total of up to thirty minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2022.