Information Interventions to Reduce Vaping in a Student Population

• ClinicalTrials.gov Identifier: NCT04982978
• Recruitment Status: Completed
• First Posted: July 29, 2021
• Last Update Posted: August 11, 2021
• Sponsor: Western University
• Information provided by (Responsible Party): Harry Prapavessis, PhD, Western University

Study Description

Brief Summary:

Participants will be allocated to one of two experimental groups using a blocked randomization method; participants will be randomized within blocks such that an equal number are assigned to each treatment. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specific sequence. Once participants are allocated to one block, each block will be randomly assigned to one of the two interventions. Participants will be randomly divided into one of two blocks, each containing a maximum of 75 participants. Possible treatment allocations within each block are (1) AABB, (2) BBAA, (3) ABAB, etc. This method ensures equal treatment allocation within each block. Each participant will then be assigned a number that will represent the participants' block as well as the participants' individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). Groups will be assigned using an Excel file to input participants into subsequent groupings and keep track of questionnaire submissions. At baseline, purpose-questionnaires will be distributed to both groups to assess history and experience with vaping and measure intention to vape less along with the "baseline self-reported questionnaires" that will be administered on Day 1 to all participants. At Day 7 (T1), respective participants will be emailed the attached video link and questionnaires and be instructed to complete the surveys after watching the participants' respective videos. The study intervention will be a single site trial delivered as a video link to the email provided by the participant; both intervention videos will play on YouTube and participants will be instructed to complete the surveys immediately after watching the video attached to the email sent to the participants. The participants will complete self-reported questionnaires at 3 follow-up periods after baseline in the 6-week protocol (all questionnaires will be sent by the student investigator (SI) to the email provided by the participants). Self-reported vaping behaviour questionnaires will be managed at baseline, Day 7 (T1), Day 30 (T2), and Day 45 (T3).

Condition or disease	Intervention/treatment	Phase
Vaping Related Disorder	Behavioral: PMT Threat Appraisal; Behavioral: General Nutrition and Lifestyle	Not Applicable

Detailed Description:

Participants will be allocated to one of two experimental groups using a blocked randomization method; participants will be randomized within blocks such that an equal number are assigned to each treatment. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specific sequence. Once participants are allocated to one block, each block will be randomly assigned to one of the two interventions. Participants will be randomly divided into one of two blocks (A or B), each containing a maximum of 75 participants. Possible treatment allocations within each block are (1) AABB, (2) BBAA, (3) ABAB, etc. This method ensures equal treatment allocation within each block. Each participant will then be assigned an ID number that will represent the participants' block as well as the participants' individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). Participants will be provided the participants' ID number via email by the SI when the LOI/C is signed by the study team and sent back to the participant. Groups will be randomly allocated to an intervention group and an Excel file will be used to organize participants into subsequent groupings and keep track of questionnaire submissions. Since the total number of participants is 150, the investigators chose the block randomization method to assign groups equally because it is short enough to prevent imbalance and long enough to prevent guessing allocation in trials. Within the study timeline, the investigators plan to implement the block randomization schema following pre-screening and informed consent processing. To avoid the presence of stratification errors the investigators further plan to review the allocation design before administering study intervention and purpose-questionnaires to prevent participant mismanagement during the protocol. At baseline, purpose-questionnaires will be distributed to both groups to assess the participants' history and experience with vaping and measure the participants' intention to vape less along with the "baseline self-reported questionnaires" that will be administered on Day 1 to all participants. At Day 7 (T1), respective participants will be emailed an attached video link and the questionnaires and be instructed to complete the surveys immediately after watching the video. The study intervention will be a single site trial delivered as a video link to the email provided by the participant; both intervention videos will play on YouTube. The participants will complete self-reported questionnaires at 3 follow-up periods after baseline in the 6-week protocol (all questionnaires will be sent by the student investigator (SI) to the email provided by the participants). Self-reported vaping behaviour questionnaires will be managed at baseline, Day 7 (T1), Day 30 (T2), and Day 45 (T3). All interventions will be created using the Qualtrics Survey Software and will be distributed to the email provided by the individual participants.

The Protection motivation theory is a theory that helps to clarify fear appeals. The protection motivation theory proposes that the participants choose to commit to certain behaviours for self-protection based on four factors: the perceived severity of a threatening event, the perceived probability of the occurrence, or vulnerability, the efficacy of the recommended preventive behaviour, and the perceived self-efficacy. Within the study design, participant groups are one of two treatment conditions: PMT present or PMT absent (attention control). The PMT present group will include an 8-minute informational video that explains the current research and health risks associated with vaping, within the context of a threat appraisal focus (Perceived Vulnerability and Perceived Severity). During this video intervention, the severity of vaping among young adult populations, incorporating both the short and long-term health effects will be presented. In addition, the negative impact of vaping and the lack of research and information that currently exists on popular vaping products will be brought to light, including the potentially devastating impact it can have on the health of young adults. The PMT absent group will feature an 8-minute nutrition and lifestyle information video as an attention control strategy in this study. During this video intervention, the general risks and benefits of nutrition and lifestyle choices will be presented. The focus of this video will be on how a balanced diet and proper lifestyle choices (i.e., adequate sleep) can benefit the participants lives in the short-term and long-term. In regard to lifestyle choices, the topic of substance abuse will be discussed briefly but without depth or research. The reason for the nutrition and lifestyle information group control intervention is because it provides informative lifestyle choices that can help promote the participants overall health without having an underlying link to vaping behaviour, separating and illustrating the impact of the specific information provided by the threat appraisal PMT, compared to general nutrition and lifestyle advice on overall vaping intention and behaviour of a Canadian student population of mostly young adults. Within the study procedures, the investigators acknowledge the potential impact retrospective questionnaires may have on participants; in the study design the investigators expect there to be a change in intention to vape as a result of the intervention, specifically in the PMT group, however, the investigators do not expect the questionnaires alone to cause statistically significant change to participant behaviour-intention or action-behaviour.

If the Principal Investigator (PI) and Student Investigator (SI) determine safe behaviour is not being practiced and/or the participant is not in a stable psychological state, the SI will email the respective participant(s) privately and explain that the participants should only continue to participate in this study if the participants feel safe and psychologically sound. The contact information of a clinical psychologist, Dr. Lisa Lee, and the Counselling Service of London, specialized in anxiety therapy and self-esteem counselling, both as part of the study team, will be included in this email or provided to participants upon request, along with the Center for Addiction and Mental Health (CAMH) distress phone number. The role of Dr. Lee and the Counselling Service of London are to work as a mental health resource for participants in cases that the PI and SI deem the participant is not practicing safe behaviour/in a stable psychological state and in circumstances where the participant requests additional aid from the study team. All participants will also be reminded to contact the participants' respective university health centre resources. In extreme cases, if the SI and PI recognize a participant is continuing to not practice safe behaviour or maintain a stable psychological state, the participant will be withdrawn from study participation and the contact information for Dr. Lee, the Counselling Services of London, and the CAMH distress line will be provided to the participant again, advising the participants to call, email, or text the health and wellness centre for additional aid.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly divided into one of two blocks (A or B), each containing a maximum of 75 participants (PMT present intervention group or the control group). The PMT present group will include an 8-minute informational video that explains the current research and health risks associated with vaping, within the context of a threat appraisal focus (Perceived Vulnerability and Perceived Severity). The PMT absent group (control group) will feature an 8-minute nutrition and lifestyle information video as an attention control strategy in this study. During this video intervention, the general risks and benefits of nutrition and lifestyle choices will be presented.
• Masking: Single (Participant)
• Masking Description: Participants will be allocated to one of two experimental groups using a blocked randomization method; participants will be randomized within blocks such that an equal number are assigned to each treatment. Once participants are allocated to one block, each participant will then be assigned an ID number that will represent their block as well as their individual participant ID number (i.e., Participant '100-123' would be in the same group as participant '100-124'). At Day 7 (T1), participants in each group will be emailed their respective intervention video links. Participants will not be given any information regarding group allocation or additional intervention information until the Letter of Study End notification is sent out to private email accounts of participants.
• Primary Purpose: Treatment
• Official Title: The Effectiveness of the Protection Motivation Theory in Reducing Vaping Behaviour in a Student Population
• Actual Study Start Date: January 7, 2021
• Actual Primary Completion Date: May 1, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PMT Threat Appraisal; The PMT present group will include an 8-minute informational video that explains the current research and health risks associated with vaping, within the context of a threat appraisal focus (Perceived Vulnerability and Perceived Severity). During this video intervention, the severity and vulnerability of vaping among young adults, both in the short and long-term health effects will be presented. In addition, the video will explain the negative impact of vaping and focus the attention of the participants on the lack of research and information that currently exists on popular vaping products and the potentially devastating impact it can have on the health of young adult populations.	Behavioral: PMT Threat Appraisal; The first half of the PMT present video will include narration by "Science Insider" producer, Benji Jones, including dialogue regarding the risks associated with vaping by Chief Pediatric Pulmonology at the NYU Winthrop Hospital, Dr. Melodi Pirzada, and information on nicotine by the Director of Pediatric Pulmonology at NYU's Langone Hassenfeld Children's Hospital, Dr. Mikhail Kazachkov. The second half of the PMT present video will include personal experiences and narratives by students at the University of Utah with information regarding our current knowledge of vaping health effects through research by Dr. Sean Maddock and Dr. Sean Callahan from the University of Utah to highlight the susceptibility of vaping for a population of young adults in university.; Other Names: Threat Appraisal; Health Threat Information
Sham Comparator: Nutrition and Lifestyle Control; The PMT absent group will feature an 8-minute nutritional information video as an attention control strategy titled, "Vaping Health Effects". During this video intervention, the general risks and benefits of nutrition and lifestyle will be presented. The focus of this video will be on how a balanced diet and proper lifestyle choices (i.e., adequate sleep, diet, etc.) can benefit the participants lives in the short-term and long-term.	Behavioral: General Nutrition and Lifestyle; The first half of the PMT absent video will be presented by the Alliance for Aging Research, including an immersive video design, explaining the impact that nutrition may have as the participants age, reviewed by Dr. Steven Austad and Senior Nutritionist Johanna Dwyer. The second half of the PMT absent video will be presented by TED-Ed with narration by Addison Anderson, including a similar immersive video design, explaining how the food the participants eat may affect our brain and overall health. The nutrition and lifestyle information design will be administered as a control because it provides informative lifestyle choices regarding nutrition that can help promote the participants overall health without having an underlying link to vaping behaviour and its subsequent effect on the status of health.; Other Names: Attention Control; Nutrition and Lifestyle

Outcome Measures

Primary Outcome Measures :

1. Effect of Threat Appraisal on Vaping Intention [ Time Frame: 6-weeks ]
   Vaping intention was measured at each time-point (baseline (Day 0), T1 (Day 7), T2 (Day 30), T3 (Day 45)) using the threat appraisal Protection Motivation Theory (PMT) questionnaire to assess individuals' relative and immediate feelings about vaping before and after intervention over the 6-week follow-up periods, reporting a score on a scale between 1 and 10, 1 representing a low perceived threat outcome and 10 illustrating a high perceived threat outcome. Threat appraisals within PMT also identified Perceived Vulnerability (PV) and Perceived Severity (PS) of individual participants at each phase of the study protocol in order to assess delayed and processed fear associated with vaping devices, following the intervention. The primary hypothesis is those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will score higher on purpose-built questions reflecting these components than their attentional information control counterparts.

Secondary Outcome Measures :

1. Effect of Perceived Vulnerability on Intention [ Time Frame: 6-weeks ]
   Reduction in intentions to vape were dependent on the extent to which individual participants experienced the intervention information. Perceived Vulnerability (PV) questions identified in the Protection Motivation Theory (PMT) questionnaire include items that question the individual participants' experience of their respective videos. Reporting was scored on a scale between 1 and 10, 1 representing a low intention and 10 a high intention to reduce vaping. These appreciations will indicate the power between inter-correlated vulnerability and severity, separately. Greater significance in vaping intention will be cross-examined to determine the influence of PV, independently. The secondary hypothesis is that those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will show lower intentions to vape and lower vaping use compared to their attentional information (nutrition and lifestyle information group) control counterpart.
2. Effect of Perceived Severity on Intention [ Time Frame: 6-weeks ]
   Reduction in intentions to vape were dependent on the extent to which participants experienced the intervention information. Perceived Severity (PS) questions identified in the Protection Motivation Theory (PMT) questionnaire included items that questioned the participants' experiences of their respective videos. Reporting was scored on a scale between 1 and 10, 1 representing a low intention and 10 a high intention to reduce vaping. These appreciations will indicate the power between inter-correlated vulnerability and severity, separately. Greater vaping intention will be cross-examined to determine the influence of PS, independently. In conjunction with perceived vulnerability, the secondary hypothesis is that those exposed to the threat appraisal information grounded in the PMT components of severity and vulnerability will show lower intentions to vape and lower vaping use compared to their attentional information (nutrition and lifestyle information group) control counterpart.

Other Outcome Measures:

1. Effect of intention on Behaviour Outcome [ Time Frame: 6-weeks ]
   Participant vaping behaviour was assessed at each timepoint (Day 0), T1 (Day 7), T2 (Day 30), T3 (Day 45)) using the Youth Vaping Questionnaire (YVQ) to assess how changes in intention to vape less translated to subsequent vaping behaviour patterns. The corroboration between intentions to vape less and reduced vaping behaviours were measured using one, five-point item, at each time-point during the six-week timeframe. Reporting was scored on a scale between 1 and 5,1 representing a low behaviour rate and 5 illustrating a high behaviour rate. The tertiary hypothesis is that reduction in intentions to vape will be associated with lower vaping use.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Ability to read and understand English
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. Males and females; Age 18 years and older
5. Self-report as current users of vaping products (>3x in the past 30 days)
6. Willingness to adhere to the study intervention regimen
7. Enrolled full-time within a registered Canadian university during the 2020-2021 school year
8. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access)
9. Willingness to stop (or at least decrease the frequency of) vaping

Exclusion Criteria:

1. Activity restrictions that limit one's ability to engage in questionnaire testing
2. Currently practicing in behaviour therapy treatment specific to vaping or attending a rehab centre
3. At the time of signing/submitting this consent form the participants are under the legal age of 18
4. Failure to complete and submit completed questionnaires within the 7-day study timeframe, starting the day that set of surveys is emailed to the participants by the student investigator

Contacts and Locations

Locations

Canada, Ontario

Western University

London, Ontario, Canada, N6A 3K7

Sponsors and Collaborators

Western University

Investigators

• Principal Investigator: Harry Prapavessi, Ph.D; Professor

  Study Documents (Full-Text)

Documents provided by Harry Prapavessis, PhD, Western University:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] December 14, 2020

More Information

Additional Information:

National Vaping Statistics 

Growth in Popularity of Vaping 

Trend of Vaping in North America 

International Vaping Statistics 

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• Responsible Party: Harry Prapavessis, PhD, Principal Investigator, Western University
• ClinicalTrials.gov Identifier: NCT04982978
• Other Study ID Numbers: 116734
• First Posted: July 29, 2021
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Identifiable data will only be stored on the Personal Vault OneDrive data storage, using BitLocker-encryption for security. Because the research team is using an electronic safety/security system for data storage, following the 7 year retainment period, data will be destroyed by selecting the folders with any identifiable material and deleting them. Next, the student investigator will permanently delete the folders from the recycle bin of the OneDrive system to remove any opportunity of data retrieval.

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

Keywords provided by Harry Prapavessis, PhD, Western University:

Protection Motivation Theory; Threat Appraisal; Health Psychology; Intention; Behaviour