Brief 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. 1.To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.
  2. 2.To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 31, 2021

Last Update Submit

August 24, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Online recruitment rate (feasibility of the study processes)

    6 months

  • Adherence to data collection methods (feasibility of the study processes)

    baseline, 4-weeks post baseline, 8-weeks post baseline

  • Attrition rate (feasibility of the study processes)

    6 months

Study Arms (2)

Joint Effort (mobile application)

EXPERIMENTAL

The Joint Effort mobile application aims to support young adults into taking action on their cannabis use. Based on the Theory of Planned Behaviour, the content focuses on intention, attitude and perceived behavioral control. Various intervention methods and strategies are used to address these determinants (e.g., personalized feedback, persuasive communication, self-observation and activation of intention). The objectives includes: to allow the individual to become aware (or more aware) of their cannabis use, to support the individual's decision-making process of taking action on their cannabis use, to guide and support the establishment and sustainability of an action plan. An optional logbook-type feature (weekly journal of cannabis use) allows personalized monitoring and data collection throughout the course of the intervention.

Other: Joint Effort

Brief normative feedback and standard information

ACTIVE COMPARATOR

The comparator is composed of a a brief normative feedback regarding last month frequency of cannabis use and basic reliable non personalized information on lower-risk cannabis use (official public websites).

Other: Brief normative feedback and standard information

Interventions

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.

Joint Effort (mobile application)

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.

Brief normative feedback and standard information

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Canada

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

October 29, 2021

Study Start

November 15, 2021

Primary Completion

April 30, 2022

Study Completion

July 31, 2022

Last Updated

August 25, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations