Behavior, DrinkingNCT06615648
Effectiveness of a PMT Intervention to Reduce Alcohol in Young Adults
A study testing PMT in people with Behavior, Drinking and Alcohol Drinking, run by Western University, Canada at 1 site in Canada.
Trial summary
This study will examine the effectiveness of a 7-minute informational video using the threat and coping components of the Protection Motivation Theory (PMT) reduces alcohol intention and behaviour among young Canadian adults. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Drinking, Alcohol Drinking, Colorectal Cancer Control and Prevention
- What is being tested?
- PMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 1 Mar 2025
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 19-25 Able to read, write and understand English
- Current alcohol drinker
- Access to necessary resources for a technology-based intervention (i.e., smartphone, computer, internet)
Who cannot join
- Under the legal drinking age in Ontario of 19 at the time of signing the consent form
- Currently actively participating in behaviour therapy treatment for alcohol or attending a rehab centre
- Are pregnant /plan to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Protection Motivation Theory in Reducing Alcohol-Related Intentions and Behaviours Among Young Adults
This study will examine the effectiveness of a 7-minute informational video using the threat and coping components of the Protection Motivation Theory (PMT) reduces alcohol intention and behaviour among young Canadian adults. Our aim is to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol, and whether goals intentions to reduce alcohol drinking are associated with actual reductions in alcohol use among this population. Participants will be randomized to view either a specific PMT-video or a non-specific video on coffee and then complete questionnaires that relate to the PMT constructs. Intention and behaviour to drink alcohol will be compared between the two conditions over a 4-week period.
Read the detailed description
According to Statistics Canada, over three-quarters of Canadians drink alcohol, with those aged 20 to 24 being the most likely to report drinking alcohol. The National Cancer Institute reports that there is strong evidence that alcohol drinking can cause several types of cancers and the consumption of alcoholic beverages is recognized as a known human carcinogen. The evidence shows that increased alcohol consumption, especially regular drinking over time, elevates the risk of developing alcohol-related cancers. Clear patterns have emerged between alcohol consumption and the development of colorectal cancer, with cases increasing particularly in young adults. With rising cases of alcohol-related cancers, particularly colorectal cancer in younger adults, and the widespread prevalence of alcohol consumption among this age group, this demographic becomes an important focus for preventative health strategies including targeted research and interventions. Therefore, the objective of the present study is to assess the effectiveness of an intervention grounded in the Protection Motivation Theory (PMT) to reduce alcohol-related intentions and behaviours among young Canadian adults. This study will provide valuable insights into young adults\' drinking patterns and cancer awareness while supporting the development of effective interventions for reducing alcohol-related cancer risks in this vulnerable population. If the proposed intervention is successful, it can guide young adults into creating healthier habits and reduce the incidence and prevalence of colorectal cancer. Protection Motivation Theory (PMT) was introduced to explain the impact of persuasive communication on behaviour, with an emphasis on cognitive mechanisms underpinning the rationale to follow or not to follow a recommended behaviour. The framework outlines how threat and coping appraisals predict behavioural intentions, which then predict behaviour. Understanding the role that perceived vulnerability, perceived severity, response efficacy and self-efficacy of the PMT model play in affecting health behaviour change will help public health educators understand how to develop specific interventions to inform this population about the relationship between colorectal cancer and alcohol and enact positive change in the decision-making related to alcohol drinking.
This study will be a two-armed randomized control trial (RCT) with repeated measures (i.e., baseline, post-intervention, and 4-week follow-up). Participants will be randomly allocated to treatment groups using block randomization and a random number generator to place participants in groups of two (intervention and attention control). The block randomization method will be conducted following the Student Investigator (SI) acquiring consent and the LOI form. Participants will then be provided with their specific study number via email. Participants will be recruited through a variety of avenues: through the Mass Recruitment system at Western University, through Facebook groups, and presentations at university club meetings and classes. Posters will be displayed across the Western campus and London and lastly through informal conversation between peers. All recruitment aids will inform the interested participant to contact the SI to receive the information letter. The PMT intervention group will be given a video podcast relating to the threat and coping appraisal components of PMT (perceived severity, perceived vulnerability, response-efficacy and self-efficacy) and include information pertaining to alcohol and its correlation to colorectal cancer. The attention control group will also be given a video podcast, however, this video will focus on general information about coffee instead of specific alcohol and colorectal cancer information. This study will be conducted entirely online, with no in-person components for participants. Upon enrollment, participants will be provided with a Letter of Information (LOI) to review, electronically sign, and submit via email. At baseline, participants will be required to complete a series of surveys that assess their drinking patterns, drinking intentions, Protection Motivation Theory (PMT) constructs, and demographic information via Qualtrics. After submitting this baseline data, one week later, participants will receive a podcast video link via YouTube. The PMT intervention video podcast will be created using iMovie on MacOS and will be a 7-minute informational video explaining the current research on alcohol and its relationship to colorectal cancer and colorectal cancer risks associated with alcohol. This will be within the context of both the threat and coping appraisals of the PMT that highlights the severity of colorectal cancer, the susceptibility of colorectal cancer and the efficacy of a coping response to reduce alcohol consumption., while those in the attentional-control group will receive general information about coffee. Following the video, participants will be asked to immediately complete surveys on the PMT constructs and their alcohol-related intentions. At the final time point, 4 weeks post-intervention, participants will be asked to complete the same surveys again, including those assessing PMT, intentions, and actual drinking behaviour. All study materials, including links to the surveys, will be sent to participants via the email address they provided at the start of the study to the SI.
The primary objectives of this study are to investigate whether the use of an informational video linking alcohol use and colorectal cancer, following the threat and coping appraisal components of the Protection Motivation Theory (PMT) framework, reduces alcohol drinking intention and behaviour among young Canadian adults. Additionally, we are aiming to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol and whether goals intentions to reduce drinking alcohol are associated with actual reductions in alcohol use. Threat and coping appraisals, goal intention and behaviour will be assessed using online self-report questionnaires at baseline, immediately post-intervention and 4 weeks through Qualtrics. We hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy, and self-efficacy will achieve higher scores on purpose-built questions reflecting these components compared to their control counterparts focused on attentional information. We further hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy and self-efficacy will show lower intentions to drink alcohol and lower alcohol use compared to their attentional information control counterparts. Finally, we hypothesize that increases in severity, vulnerability, response efficacy and self-efficacy of alcohol usage will be associated with a reduction in intentions to drink. Data collected throughout this study will be quantitative in nature and will be analyzed using a variety of statistical tests which could include t-tests, analysis of variance, correlation analyses, and multiple regression analyses. Descriptive statistics will be done and continuous data will be presented with standard deviation, mean, median and range. As data will be collected at multiple points throughout the study, a repeated measures analysis will be used to analyze the outcomes of variables at different points throughout the study. This will allow for the comparison between the intervention and control groups as the repeated measures correlation model tells us the strength of the linear correlation between the two groups.
- Conditions
- Behavior, Drinking, Alcohol Drinking, Colorectal Cancer Control and Prevention, Healthy Volunteers
- Being tested
- PMT, Non-contact Control
- Keywords
- Protection Motivation Theory, Alcohol, Alcohol Intention, Alcohol Behaviour, Colorectal Cancer, Behaviour Change
- Medical subject headings
- Drinking Behavior, Alcohol Drinking, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMTBehavioural
7-minute PMT intervention video
Non-contact ControlBehavioural
6-minute alternative video
| Study group | Role | What they receive |
|---|---|---|
| PMT Information | Experimental | The participant will watch the PMT-video and then complete the associated questionnaires. Receives: Behavioral: PMT |
| Non-contact Control | Active comparator | The participant will watch a non-specific video about coffee and then complete the associated questionnaires. Receives: Behavioral: Non-contact Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Intention
Participants alcohol intentions measured using an online questionnaire.
Measured: From enrollment to the end of treatment at 4-weeks post-intervention.
Alcohol Behaviour
Participants alcohol consumption as measured using an online questionnaire.
Measured: From enrollment to the end of treatment at 4-weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, DrinkingStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Parapavessis, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615648
- Sponsor's protocol ID
- PMT and Alcohol
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Protection Motivation Theory in Reducing Alcohol-Related Intentions and Behaviours Among Young Adults
- ClinicalTrials.gov ID
- NCT06615648
- Acronym / sponsor ID
- PMT and Alcohol
- Conditions
- Behavior, Drinking, Alcohol Drinking, Colorectal Cancer Control and Prevention, Healthy Volunteers
- Keywords
- Protection Motivation Theory, Alcohol, Alcohol Intention, Alcohol Behaviour, Colorectal Cancer, Behaviour Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
This study will examine the effectiveness of a 7-minute informational video using the threat and coping components of the Protection Motivation Theory (PMT) reduces alcohol intention and behaviour among young Canadian adults. Our aim is to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol, and whether goals intentions to reduce alcohol drinking are associated with actual reductions in alcohol use among this population. Participants will be randomized to view either a specific PMT-video or a non-specific video on coffee and then complete questionnaires that relate to the PMT constructs. Intention and behaviour to drink alcohol will be compared between the two conditions over a 4-week period.
Detailed description
According to Statistics Canada, over three-quarters of Canadians drink alcohol, with those aged 20 to 24 being the most likely to report drinking alcohol. The National Cancer Institute reports that there is strong evidence that alcohol drinking can cause several types of cancers and the consumption of alcoholic beverages is recognized as a known human carcinogen. The evidence shows that increased alcohol consumption, especially regular drinking over time, elevates the risk of developing alcohol-related cancers. Clear patterns have emerged between alcohol consumption and the development of colorectal cancer, with cases increasing particularly in young adults. With rising cases of alcohol-related cancers, particularly colorectal cancer in younger adults, and the widespread prevalence of alcohol consumption among this age group, this demographic becomes an important focus for preventative health strategies including targeted research and interventions. Therefore, the objective of the present study is to assess the effectiveness of an intervention grounded in the Protection Motivation Theory (PMT) to reduce alcohol-related intentions and behaviours among young Canadian adults. This study will provide valuable insights into young adults\' drinking patterns and cancer awareness while supporting the development of effective interventions for reducing alcohol-related cancer risks in this vulnerable population. If the proposed intervention is successful, it can guide young adults into creating healthier habits and reduce the incidence and prevalence of colorectal cancer. Protection Motivation Theory (PMT) was introduced to explain the impact of persuasive communication on behaviour, with an emphasis on cognitive mechanisms underpinning the rationale to follow or not to follow a recommended behaviour. The framework outlines how threat and coping appraisals predict behavioural intentions, which then predict behaviour. Understanding the role that perceived vulnerability, perceived severity, response efficacy and self-efficacy of the PMT model play in affecting health behaviour change will help public health educators understand how to develop specific interventions to inform this population about the relationship between colorectal cancer and alcohol and enact positive change in the decision-making related to alcohol drinking.
This study will be a two-armed randomized control trial (RCT) with repeated measures (i.e., baseline, post-intervention, and 4-week follow-up). Participants will be randomly allocated to treatment groups using block randomization and a random number generator to place participants in groups of two (intervention and attention control). The block randomization method will be conducted following the Student Investigator (SI) acquiring consent and the LOI form. Participants will then be provided with their specific study number via email. Participants will be recruited through a variety of avenues: through the Mass Recruitment system at Western University, through Facebook groups, and presentations at university club meetings and classes. Posters will be displayed across the Western campus and London and lastly through informal conversation between peers. All recruitment aids will inform the interested participant to contact the SI to receive the information letter. The PMT intervention group will be given a video podcast relating to the threat and coping appraisal components of PMT (perceived severity, perceived vulnerability, response-efficacy and self-efficacy) and include information pertaining to alcohol and its correlation to colorectal cancer. The attention control group will also be given a video podcast, however, this video will focus on general information about coffee instead of specific alcohol and colorectal cancer information. This study will be conducted entirely online, with no in-person components for participants. Upon enrollment, participants will be provided with a Letter of Information (LOI) to review, electronically sign, and submit via email. At baseline, participants will be required to complete a series of surveys that assess their drinking patterns, drinking intentions, Protection Motivation Theory (PMT) constructs, and demographic information via Qualtrics. After submitting this baseline data, one week later, participants will receive a podcast video link via YouTube. The PMT intervention video podcast will be created using iMovie on MacOS and will be a 7-minute informational video explaining the current research on alcohol and its relationship to colorectal cancer and colorectal cancer risks associated with alcohol. This will be within the context of both the threat and coping appraisals of the PMT that highlights the severity of colorectal cancer, the susceptibility of colorectal cancer and the efficacy of a coping response to reduce alcohol consumption., while those in the attentional-control group will receive general information about coffee. Following the video, participants will be asked to immediately complete surveys on the PMT constructs and their alcohol-related intentions. At the final time point, 4 weeks post-intervention, participants will be asked to complete the same surveys again, including those assessing PMT, intentions, and actual drinking behaviour. All study materials, including links to the surveys, will be sent to participants via the email address they provided at the start of the study to the SI.
The primary objectives of this study are to investigate whether the use of an informational video linking alcohol use and colorectal cancer, following the threat and coping appraisal components of the Protection Motivation Theory (PMT) framework, reduces alcohol drinking intention and behaviour among young Canadian adults. Additionally, we are aiming to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol and whether goals intentions to reduce drinking alcohol are associated with actual reductions in alcohol use. Threat and coping appraisals, goal intention and behaviour will be assessed using online self-report questionnaires at baseline, immediately post-intervention and 4 weeks through Qualtrics. We hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy, and self-efficacy will achieve higher scores on purpose-built questions reflecting these components compared to their control counterparts focused on attentional information. We further hypothesize that those exposed to the threat and coping appraisal information grounded in the PMT components of severity, vulnerability, response efficacy and self-efficacy will show lower intentions to drink alcohol and lower alcohol use compared to their attentional information control counterparts. Finally, we hypothesize that increases in severity, vulnerability, response efficacy and self-efficacy of alcohol usage will be associated with a reduction in intentions to drink. Data collected throughout this study will be quantitative in nature and will be analyzed using a variety of statistical tests which could include t-tests, analysis of variance, correlation analyses, and multiple regression analyses. Descriptive statistics will be done and continuous data will be presented with standard deviation, mean, median and range. As data will be collected at multiple points throughout the study, a repeated measures analysis will be used to analyze the outcomes of variables at different points throughout the study. This will allow for the comparison between the intervention and control groups as the repeated measures correlation model tells us the strength of the linear correlation between the two groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMT Information | Experimental | Behavioral: PMTThe participant will watch the PMT-video and then complete the associated questionnaires. |
| Non-contact Control | Active comparator | Behavioral: Non-contact ControlThe participant will watch a non-specific video about coffee and then complete the associated questionnaires. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 19-25 Able to read, write and understand English
- Current alcohol drinker
- Access to necessary resources for a technology-based intervention (i.e., smartphone, computer, internet)
Key exclusion criteria (3 listed)
- Under the legal drinking age in Ontario of 19 at the time of signing the consent form
- Currently actively participating in behaviour therapy treatment for alcohol or attending a rehab centre
- Are pregnant /plan to become pregnant during the study period
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 |
|---|---|---|
| PMT7-minute PMT intervention video | Behavioural | PMT Information |
| Non-contact Control6-minute alternative video | Behavioural | Non-contact Control |
Primary outcome
Alcohol Intention
Time frame: From enrollment to the end of treatment at 4-weeks post-intervention.
Participants alcohol intentions measured using an online questionnaire.
Alcohol Behaviour
Time frame: From enrollment to the end of treatment at 4-weeks post-intervention.
Participants alcohol consumption as measured using an online questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Drinking Among Young AdultsLink provided by the sponsor.
- Efficacy of a non-drinking mental simulation intervention for reducing student alcohol consumptionLink provided by the sponsor.
- Colorectal Cancer in Young PeopleLink provided by the sponsor.
- Protection Motivation Theory (PMT)Link provided by the sponsor.
- Alcohol and Cancer RiskLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Harry Parapavessis principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMT in people with Behavior, Drinking and Alcohol Drinking, run by Western University, Canada 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 3 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harry Prapavessis (5196612111 ext. 80173, hprapave@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Intention (time frame: From enrollment to the end of treatment at 4-weeks post-intervention.). 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 26 Sep 2024.