AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
What is being tested?
PMT
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.

Harry Prapavessis contact

5196612111 ext. 80173

hprapave@uwo.ca

Nicole S Moses contact

6472140477

nmoses3@uwo.ca

Canada1 site
  • Western University

    London, Ontario, N6A3K7

Other trials in Canada

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.

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 groups in NCT06615648
Study groupRoleWhat they receive
PMT InformationExperimentalThe participant will watch the PMT-video and then complete the associated questionnaires.
Receives: Behavioral: PMT
Non-contact ControlActive comparatorThe 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.

  1. Alcohol Intention

    Participants alcohol intentions measured using an online questionnaire.

    Measured: From enrollment to the end of treatment at 4-weeks post-intervention.

  2. 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.

  1. First posted26 Sep 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in