Development and Evaluation of HighAlert

NCT ID: NCT06098573

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-09-10

Brief Summary

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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

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Conditions

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Cannabis Youth Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Program 1: High Alert

High Alert

Group Type EXPERIMENTAL

High Alert

Intervention Type 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

Program 2: Information condition

Active Control- Information condition

Group Type ACTIVE_COMPARATOR

Information condition

Intervention Type 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

Passive control- No contact

Group Type PLACEBO_COMPARATOR

No contact

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

No contact

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Western University

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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123368

Identifier Type: -

Identifier Source: org_study_id

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