Development and Evaluation of HighAlert

NCT06098573 | Completed

• 1 other identifier: 123368
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis; Youth Drinking

Outcome Measures

Primary Outcomes (1)

• Past driving under the influence of cannabis

  "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).

  3-months

Study Arms (3)

Program 1: High Alert

EXPERIMENTAL

High Alert

Behavioral: High Alert

Program 2: Information condition

ACTIVE COMPARATOR

Active Control- Information condition

Behavioral: Information condition

No contact

PLACEBO COMPARATOR

Passive control- No contact

Behavioral: No contact

Interventions

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

Program 1: High Alert

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.

Program 2: Information condition

No contact BEHAVIORAL

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

No contact

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6G 1G9, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse; Underage Drinking

Interventions

Medication Errors

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: November 1, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)