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Development and Evaluation of HighAlert

Primary Purpose

Cannabis, Youth Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Alert
Information condition
No contact
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants will include young Ontario drivers who: (a) are ages 18-24, (b) have a valid Ontario driver's license (i.e., G level full driver's license or G2 probationary license), (c) have access to a motor vehicle, (d) report DUIC at least three times in the past three months, (e) are proficient in English, and (f) have a smartphone they can complete the intervention with. Exclusion Criteria: Individuals under 18 are excluded, as cannabis use is prohibited for this group, and those over 24 as they are beyond the high-risk demographic for road traffic collisions in Canada.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Program 1: High Alert

    Program 2: Information condition

    No contact

    Arm Description

    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

    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.

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

    Outcomes

    Primary Outcome Measures

    Past DUIC
    "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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Western University, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06098573
    Brief Title
    Development and Evaluation of HighAlert
    Official Title
    Development and Evaluation of 'High Alert', A Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Western University, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis, Youth Drinking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Program 1: High Alert
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Program 2: Information condition
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No contact
    Arm Type
    Placebo Comparator
    Arm Description
    Participants in the passive control will receive no contact until the three and six-month follow-ups.
    Intervention Type
    Behavioral
    Intervention Name(s)
    High Alert
    Intervention Description
    see above
    Intervention Type
    Behavioral
    Intervention Name(s)
    Information condition
    Intervention Description
    see above
    Intervention Type
    Behavioral
    Intervention Name(s)
    No contact
    Intervention Description
    see above
    Primary Outcome Measure Information:
    Title
    Past DUIC
    Description
    "in the past three months, how many times have you driven within two hours of inhaling cannabis or within four hours of ingesting cannabis"
    Time Frame
    3-months
    Title
    Risky Cannabis Use
    Description
    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
    Time Frame
    3-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants will include young Ontario drivers who: (a) are ages 18-24, (b) have a valid Ontario driver's license (i.e., G level full driver's license or G2 probationary license), (c) have access to a motor vehicle, (d) report DUIC at least three times in the past three months, (e) are proficient in English, and (f) have a smartphone they can complete the intervention with. Exclusion Criteria: Individuals under 18 are excluded, as cannabis use is prohibited for this group, and those over 24 as they are beyond the high-risk demographic for road traffic collisions in Canada.

    12. IPD Sharing Statement

    Learn more about this trial

    Development and Evaluation of HighAlert

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