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Development and Evaluation of HighAlert

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ClinicalTrials.gov Identifier: NCT06098573
Recruitment Status : Recruiting
First Posted : October 24, 2023
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Youth Drinking Behavioral: High Alert Behavioral: Information condition Behavioral: No contact Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Development and Evaluation of 'High Alert', A Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Program 1: High Alert
High Alert
 Behavioral: High Alert
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
Active Comparator: Program 2: Information condition
Active Control- Information condition
 Behavioral: Information condition
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.
Placebo Comparator: No contact
Passive control- No contact
 Behavioral: No contact
Participants in the passive control will receive no contact until the three and six-month follow-ups.


Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06098573


Locations
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Canada, Ontario
Western University Recruiting
London, Ontario, Canada, N6G 1G9
Contact: Liliana Alvarez    519-661-2111 ext 88957    lalvare2@uwo.ca   
Sponsors and Collaborators
Western University, Canada
More Information
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT06098573    
Other Study ID Numbers: 123368
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Underage Drinking
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Alcohol Drinking
Drinking Behavior