Joint Effort Study

Cannabis Use Clinical Trial

— JointEffort  

Official title:

Taking Action to Better Manage Cannabis Use Among Young Adults: Preliminary Evaluation of a Digital Tailored Prevention Tool With a Pilot Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099016
• Other study ID #: 21.196
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2021
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are:

1. To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.

2. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• active cannabis user (i.e., having used cannabis at least once in the past month)

• able to understand French

• own an iPhone (running on iOS 13 or higher).

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Other:
• Joint Effort
The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and 14) in French language. It aims to support young adults in school who have used cannabis in the past month into taking action on their cannabis use.
• Brief normative feedback and standard information
The brief normative feedback is based on the frequency of cannabis use use. Participants will also be offered basic reliable non personalized information on lower-risk cannabis use in the form of official public websites.

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of the developed mobile application (acceptability)	Uptake is defined as the act of downloading and installing the mobile application (Szinay, Jones, Chadborn, Brown, & Naughton, 2020). The uptake rate will measure the proportion of participants randomized to the EG group that downloaded the mobile application (via the Apple iOS App Store) versus those who did not do it.	6 months
Primary	Subjective engagement with the developed mobile application (acceptability)	Subjective engagement (self-reported) will be measured by using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF)(O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability; and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimensions will be compared to indicate which are rated more highly than other.	4-weeks post baseline
Primary	Objective engagement with the developed mobile application (acceptability)	Objective engagement (ie. number of screens viewed by participants) will be assessed. This data will be collected automatically when users log into the application.	6 months
Primary	Mobile application appreciation (acceptability)	The intervention appreciation will be measured with the User Version of the Mobile Application Rating Scale (uMARS) (Stoyanov, Hides, Kavanagh, & Wilson, 2016). The uMARS is a 20-item measure that includes 4 objective quality subscales regarding engagement, functionality, aesthetics, and information quality and 1 subjective quality subscale. Each item is rated on a 5-point scale ranging from inadequate (+1) to excellent (+5). The possible total score ranges between 20 and 100; a higher scores indicates a higher appreciation.	2-weeks post baseline
Secondary	Online recruitment rate (feasibility of the study processes)	The recruitment rate (ie. number of participants who signed the inform consent form) will be assessed.	6 months
Secondary	Adherence to data collection methods (feasibility of the study processes)	The adherence to data collection methods (ie. number of missing data) will be assessed.	baseline, 4-weeks post baseline, 8-weeks post baseline
Secondary	Attrition rate (feasibility of the study processes)	The attrition rate will be measured by taking into account the proportion of participants who completed only the baseline but no follow-up assessment (study dropouts). The proportion of participants who completed the baseline assessment and only one follow-up and the proportion of study completers (who completed all assessments) will also be determined. Loss-to-follow up in both intervention groups will be compared (experimental VS control groups).	6 months

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