- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812613
Tobacco-Concurrent Addictions in At-Risk Youth in Ottawa (TCAY-Ottawa)
Tobacco Concurrent Addictions in At-Risk Youth in Ottawa: A Mixed Methods Community-Based Participatory Action Research Project (TCAY- Ottawa)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Objectives:
Understand the real reasons that impact cannabis use, positive and negative experiences for that, how much cannabis use effect on mental health, recognize the patterns of cannabis use between deferent generation among marginalized populations with a disproportionate burden of mental illness. Also, use meaningful qualitative method to encourage storytelling and authentic sharing of individual experiences of mental health and cannabis use.
Primary Patient-Oriented Outcome: Improved engagement and quality of life in participants. As well, reduced self-reported poly-substance use.
Study Design: Phase 1: will involve gathering information on the root causes or facilitators of poly-substance use among at-risk youth, the types of drug use that is most prevalent among at-risk youth, and the early and ongoing points of access to licit and illicit substances. Phase II: will involve a single arm prospective cohort study looking to tackle poly-substance use in marginalized youth by providing an individualized, youth-tailored (i.e. based on qualitative results obtained in phase I), social-based intervention with optional access to an licensed mental health and substance use nurse counselling. Photovoice: The 20 recruited participants will be trained on how to use Photovoice. Dialogue: Ten interested Photovoice participants will be invited to be paired one-on-one with an adult-aged (aged 27+) participant of the MHCC OCM project.
Setting: 1) The Bridge Engagement Centre, Ottawa and 2) Operation Come Home, Ottawa
Expertise: The PI is well versed in community-based research. Dr. Pakhale led the PROMPT project, a community-based smoking cessation project engaging a similar target population. Partnering with Operation Come Home and Ms. Elspeth McKay, the executive director of Operation Come Home, provides the PI with expert experience in engaging this marginalized youth population. Together the team is very experienced in substance dependence and the target population. The investigators collective expertise with links to the target community will support the implementation of the trial.
Outcomes: Community-based participatory and peer-led research holds a tremendous potential in investigating solutions 'for the people, by and with the people'. Outcomes of this trial will aid policy makers in designing and implementing effective programs to treat substance dependence in marginalized youth populations.
Timeline: Participants will be invited to complete the study-specific survey monthly, for 6-months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sadia Jama
- Phone Number: 613-890-9741
- Email: sjama036@uottawa.ca
Study Contact Backup
- Name: Nina Huynh
- Phone Number: 613-241-0677
- Email: nhuynh@toh.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1G 5T2
- The Bridge Engagement Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Are currently living in Ottawa for at least 3 months prior to enrolment.
- Are homeless or insecurely housed (from OCH and the Bridge).
- 16 years or older.
- currently use or have a past history of cannabis use
- Self-report a mental illness.
Exclusion criteria:
• Not meeting inclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Photovoice
Three youth community peer researchers from marginalized communities will be recruited and involved in every aspect of the project. We will recruit 20 participants from marginalized communities with a current or past history of cannabis use, who can speak English, and who are between 16 and 26 years old. Participants will receive training on study procedures, basics of photography and disposable camera to document their experiences with mental health and substance use over the span of two weeks. Community peer researchers and research team will conduct photoanalysis and creation of the description of the five photos chosen by each participant. Duoethnographic dialogue: 10 youth participants will be paired with an older participant of TCAY study to have an open discussion to explore their experiences with cannabis and mental health. This conversation will be facilitated by community peer researcher, recorded and transcribed verbatim. |
Mix-method community based participatory action research
Phase 1 study: we will conduct 50 semi-structured questionnaires. Data from the participants and literature will then be triangulated, coded, and analyzed using NVivo software. Researchers will transcribe interviews, create a code guide, code, analyze and report the data to appropriately inform the intervention (Phase 2). Phase 2: 6 month follow-up with a questionnaire focused on socio-demographic data, questions on participants' smoking and other substance use habits, mental health, as well as questions on participants' social networks.. Participants will be informed that they can skip any of the questions if they are uncomfortable answering them. Qualitative data will be analyzed using NVivo, and quantitative data will be analyzed using SAS or R software. Phase 2 findings will be reported and submitted to an appropriate peer-review journal. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tobacco and other drug use reduction
Time Frame: 6 Months
|
Design and deliver an individualized intervention (6 months) to help at-risk youth decrease concurrent poly-substance use.
|
6 Months
|
Explore the frequency of tobacco and other drug use
Time Frame: 6 Months
|
Understand the problem of substance use and addiction among youth between the ages of 16 years or older who are homeless or insecurely housed (as defined-by project step) in Downtown Ottawa, and who attend programs at project step partner, OCH
|
6 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Smita Pakhale, M.D., Ottawa Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180595-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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