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Joint Effort 2.0: a Mobile Application With University Students (JOINTEFFORT)

Primary Purpose

Cannabis Use, Cannabis, Cannabis Dependence

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Joint Effort
Brief normative feedback and standard information
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cannabis Use

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged between 18-35 years old Be a non-medical cannabis user and have used in the last month Understand, read and write French Own a smartphone (iPhone) Exclusion Criteria: None

Sites / Locations

  • Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Joint Effort mobile application

Brief normative feedback and standard information

Arm Description

The Joint Effort mobile application aims to support young adults in 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 include: 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, and 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.

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

Outcomes

Primary Outcome Measures

Change in Protective Behavioral Strategies for Marijuana (PBSM-17) used
The French version of the questionnaire translated by Côté et al. (2021) will be used. The 17 items proposed in the scale, each representing a behavioral protection strategy, are measured in terms of frequency of use on a six-point Likert-type scale (never, rarely, occasionally, sometimes, often and always). As indicated by its developers, the total score of the PBSM-17 is obtained by calculating the total score of each item and then converting this raw score into a standardized form (T-score) ranging from 15 to 73.

Secondary Outcome Measures

Change in intention to take action on cannabis use
Intention is assessed by three items with a 7 points Likert Scale as recommended by Ajzen (2013): 1) "I intend to take action on my cannabis use within the next month" will be rated on a scale from 1 = strongly disagree to 7 = strongly agree; 2) "Over the next month, the chances of me taking action on my cannabis use are …" will be rated on a scale from 1=very low to 7=very high; 3) "Over the next month, I will be taking action on my cannabis use" will be rated on a scale from 1=very unlikely to 7=very likely. Intention items scores are tallied for an overall score (range of 3-21).
Cannabis use frequency
The frequency of cannabis use will be assessed using a question previously used in the Quebec (Canada) Survey on Cannabis (2022).
Severity of Dependence
Measured with the Severity of Dependence Scale (SDS) scale (Martin et al., 2006) which includes five items related to compulsive behaviors, concerns, anxiety, and feelings of loss of control in the context of cannabis use. Four of the items are scored on a Likert-type scale ranging from "never/almost never" (1) to "always" (4) and one item offers a scale ranging from "not difficult" (1) to "impossible" (4). Severity of dependance items scores are tallied for an overall score (range of 5-20).
Subjective engagement with the developed mobile application (acceptability)
Subjective engagement (self-reported) will be measured 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 dimension will be compared to indicate which are rated more highly than others.
Number of screens viewed in the mobile application
Objective data. This data will be collected automatically when users log into the application.
Total time of use of the mobile application
Objective data. This data will be collected automatically when users log into the application.
Number of days the mobile application was used
Objective data. This data will be collected automatically when users log into the application.

Full Information

First Posted
November 8, 2022
Last Updated
June 28, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05620433
Brief Title
Joint Effort 2.0: a Mobile Application With University Students
Acronym
JOINTEFFORT
Official Title
Joint Effort, a Mobile Prevention and Harm Reduction Application
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

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
The purpose of this study is to evaluate quantitatively and qualitatively a mobile application, Joint Effort, targeting safe cannabis use among consumers. This randomized controlled trial is currently conducted on the Joint Effort mobile application.
Detailed Description
This online randomized controlled trial with parallel groups is conducted in Quebec (Canada). Interested participants are invited to visit the study's website at www.etudejointeeffort.ca The study's Website contains text explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire. After completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (Joint Effort mobile application) or to a control group (brief normative feedback and standard information). Four weeks and eight weeks after the baseline questionnaire, participants will complete the online questionnaires again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Cannabis, Cannabis Dependence, Cannabis Smoking, Cannabis Use, Unspecified

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Joint Effort mobile application
Arm Type
Experimental
Arm Description
The Joint Effort mobile application aims to support young adults in 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 include: 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, and 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.
Arm Title
Brief normative feedback and standard information
Arm Type
Active Comparator
Arm Description
The comparator is composed of a brief normative feedback regarding last month's frequency of cannabis use and basic reliable non-personalized information on lower-risk cannabis use (official public websites).
Intervention Type
Other
Intervention Name(s)
Joint Effort
Intervention Description
The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and higher) 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.
Intervention Type
Other
Intervention Name(s)
Brief normative feedback and standard information
Intervention Description
The brief normative feedback is based on the frequency of cannabis use. Participants will also be offered basic reliable non-personalized information on lower-risk cannabis use in the form of official public websites.
Primary Outcome Measure Information:
Title
Change in Protective Behavioral Strategies for Marijuana (PBSM-17) used
Description
The French version of the questionnaire translated by Côté et al. (2021) will be used. The 17 items proposed in the scale, each representing a behavioral protection strategy, are measured in terms of frequency of use on a six-point Likert-type scale (never, rarely, occasionally, sometimes, often and always). As indicated by its developers, the total score of the PBSM-17 is obtained by calculating the total score of each item and then converting this raw score into a standardized form (T-score) ranging from 15 to 73.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in intention to take action on cannabis use
Description
Intention is assessed by three items with a 7 points Likert Scale as recommended by Ajzen (2013): 1) "I intend to take action on my cannabis use within the next month" will be rated on a scale from 1 = strongly disagree to 7 = strongly agree; 2) "Over the next month, the chances of me taking action on my cannabis use are …" will be rated on a scale from 1=very low to 7=very high; 3) "Over the next month, I will be taking action on my cannabis use" will be rated on a scale from 1=very unlikely to 7=very likely. Intention items scores are tallied for an overall score (range of 3-21).
Time Frame
8 weeks
Title
Cannabis use frequency
Description
The frequency of cannabis use will be assessed using a question previously used in the Quebec (Canada) Survey on Cannabis (2022).
Time Frame
8 weeks
Title
Severity of Dependence
Description
Measured with the Severity of Dependence Scale (SDS) scale (Martin et al., 2006) which includes five items related to compulsive behaviors, concerns, anxiety, and feelings of loss of control in the context of cannabis use. Four of the items are scored on a Likert-type scale ranging from "never/almost never" (1) to "always" (4) and one item offers a scale ranging from "not difficult" (1) to "impossible" (4). Severity of dependance items scores are tallied for an overall score (range of 5-20).
Time Frame
8 weeks
Title
Subjective engagement with the developed mobile application (acceptability)
Description
Subjective engagement (self-reported) will be measured 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 dimension will be compared to indicate which are rated more highly than others.
Time Frame
4 weeks
Title
Number of screens viewed in the mobile application
Description
Objective data. This data will be collected automatically when users log into the application.
Time Frame
8 weeks
Title
Total time of use of the mobile application
Description
Objective data. This data will be collected automatically when users log into the application.
Time Frame
8 weeks
Title
Number of days the mobile application was used
Description
Objective data. This data will be collected automatically when users log into the application.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged between 18-35 years old Be a non-medical cannabis user and have used in the last month Understand, read and write French Own a smartphone (iPhone) Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Côté, PhD
Phone
514 890-8000
Ext
15536
Email
jose.cote@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Côté, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Jutras-Aswad, MD MSN
Organizational Affiliation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvie Cossette, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christine Genest, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shalini Lal, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judith Lapierre, PhD
Organizational Affiliation
Laval University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gabrielle Pagé, PhD
Organizational Affiliation
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jingui Cheng, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
Facility Information:
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Côté, PhD
Phone
514 890-8000
Ext
15536
Email
jose.cote@umontreal.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.crsi.umontreal.ca/en/
Description
RESEARCH CHAIR IN INNOVATIVE NURSING PRACTICES

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Joint Effort 2.0: a Mobile Application With University Students

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