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Development and Evaluation of HighAlert

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 18, 2023
First Posted Date  ICMJE October 24, 2023
Last Update Posted Date December 12, 2023
Actual Study Start Date  ICMJE November 1, 2023
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2023)		 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2023)
  • Past DUIC [ 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"
  • Risky Cannabis Use [ Time Frame: 3-months ]
    Risky cannabis use will be measured with a five-item scale developed based on past 3-month adherence to the Lower-Risk Cannabis Use Guidelines
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development and Evaluation of HighAlert
Official Title  ICMJE Development and Evaluation of 'High Alert', A Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cannabis
  • Youth Drinking
Intervention  ICMJE
  • 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
  • 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.
  • Behavioral: No contact
    Participants in the passive control will receive no contact until the three and six-month follow-ups.
Study Arms  ICMJE
  • Experimental: Program 1: High Alert
    High Alert
    Intervention: Behavioral: High Alert
  • Active Comparator: Program 2: Information condition
    Active Control- Information condition
    Intervention: Behavioral: Information condition
  • Placebo Comparator: No contact
    Passive control- No contact
    Intervention: Behavioral: No contact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2023)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2024
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06098573
Other Study ID Numbers  ICMJE 123368
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Western University, Canada
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Western University, Canada
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Western University, Canada
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP