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Completed

NCT Number: NCT06098573

Development and Evaluation of HighAlert

In Canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (DUIC). As such, developing effective and practical DUIC prevention efforts is crucial. This study aims to evaluate the effects of 'High Alert' in reducing 3-month risky cannabis use and DUIC among young Ontarian drivers. 'High Alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'High Alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of DUIC, and strategies to avoid DUIC. A pilot randomized controlled trial will compare the effects of 'High Alert' with an active control (DUIC Information) and passive control (no contact). Overall, effectively preventing DUIC among youth is critically needed and time-sensitive.

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Key information

Conditions

Cannabis Adolescent Behavior Alcohol Drinking Behavior Chemically-Induced Disorders Drinking Behavior Marijuana Abuse Mental Disorders Substance-Related Disorders Underage Drinking Youth Drinking

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University

London, Ontario, N6G 1G9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • ages 18-24
  • valid Ontario driver's license
  • access to a motor vehicle
  • report DUIC at least three times in the past three months
  • proficient in English
  • have a smartphone they can complete the intervention with.

Exclusion criteria

  • Individuals under 18 and those over 24
  • resides outside Ontario
  • non-drivers

Treatment and study plan

High Alert

Behavioral

Participants assigned to the 'High Alert' condition will complete four interactive modules using their smartphones. These modules are hosted online via the Computerized Intervention Authoring Software, version 3.0 (https://www.cias.app [CIAS]). CIAS is a non- commercial, easily modifiable, web-based intervention platform used widely in the digital substance use literature. No identifiable information is requested or stored in CIAS. This program is only intended to deliver the content interactively. None of the questions asked in CIAS will be treated as research data. We will only report on the proportion of questions answered by participants (as a measure of adherence). Individual responses to questions will not be analyzed nor reported on. The purpose of the questions is for participants to engage with the content interactively

Information condition

Behavioral

Participants in the DUIC Information condition will receive a Qualtrics link with six infographics created to educate about DUIC. Four infographics were retrieved from government websites, one was provided by a non-profit (i.e., Arrive Alive Drive Sober), and the research team created the final one. After reviewing each infographic, participants will respond to a few questions about the infographic. Questions asked to the DUIC Info Control will obtain data related to: seeing the infographic before, perceptions on the infographic content, aspects they liked/disliked, and likelihood to share with their peers. All items will be treated as research data.

No contact

Behavioral

Participants in the passive control will receive no contact until the three and six-month follow-ups.

Primary outcomes

  1. Past driving under the influence of cannabis

    Time frame: 3-months

    "in the past three months, how many times have you driven within two hours of inhaling cannabis or within four hours of ingesting cannabis". Continuous variable (min=0, no maximum). Higher numbers indicate worse outcome (i.e., more impaired driving).

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Development and Evaluation of 'High Alert', a Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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