- 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
Part 1: Youth and Polysubstance Use This study aims to expand the reach of the existing PROMPT intervention operationalized at the Bridge for vulnerable polysubstance using youth who smoke tobacco. The peer-led PROMPT intervention aims to reduce rates of tobacco smoking and poly-substances use among populations who are homeless or at-risk for homelessness.
Research Objectives:
Understand the positive and negative experiences of cannabis use, the effect of cannabis use on mental health, and recognize the patterns of cannabis use between different generations among marginalized populations with a disproportionate burden of mental illness. Additionally, use meaningful qualitative methods to encourage storytelling and authentic sharing of individual experiences of cannabis use and mental health.
Sub-objectives: 1) Identify trends in tobacco and poly-substance use among at-risk youth in Ottawa. Surveys and interview guides have been created with the intention of understanding the root cause of tobacco and poly-substance use among at-risk youth who attend alternative schooling, their perception of tobacco/drug use, types of tobacco and drug use that are most prevalent among these youth, and where youth access tobacco and other substances.
2) Appropriately modify and implement the peer-led PROMPT intervention for 20 youth recruited into the program. The peer-led intervention includes free access to nurse counselling and support on homelessness, addictions, and mental health. You will also access a safe and non-judgemental space for one-to-one peer support. Modifications to this intervention will be dependent on the findings from data collected in the first phase of the study (sub-objective 1).
3) Upon completion of the research project, a manuscript will be submitted for publication in a peer-reviewed, open access journal, and various knowledge translation initiatives (e.g., infographics, seminars, etc.) will be undertaken to ensure that study findings are meaningfully available to organizations that serve at-risk youth who smoke tobacco and/or use poly-substances.
4) Compare healthcare utilization (ER visits and hospitalizations) over one year after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).
Part 2: Tobacco, Cannabis, and Mental Health Marginalized groups, such as polysubstance using street-involved, homeless, and/or racialized individuals, have been overlooked by studies that investigated the causal relationship between cannabis and mental health. As a result, a paucity of data exists on the motives and reasons that influence cannabis use in these populations, and their potential impact on mental health. This knowledge gap is concerning as marginalized groups experience disproportionate rates of mental illness, and due to social and structural inequities are more likely to abuse drugs, including cannabis, relative to the general population. Therefore, the unique experiences of this population should be investigated to further our understanding on the relationship between polysubstance use, cannabis, and mental health.
In marginalized communities, patterns of cannabis use, including type, duration, and frequency of use, may mediate the mental health effects of cannabis. While recreational cannabis is legal in Canada, marginalized populations may have limited access to Ontario's legal cannabis retailers. As a result, individuals may seek illegal or 'street' cannabis, which may be combined with other illicit drugs and/or tobacco that could influence mental health. Therefore, patterns of cannabis consumption, and the source of cannabis, should be evaluated in relation to mental health.
In light of the above, we propose the use of mixed methods to investigate the lived experience of people with mental illness, risk for cardiovascular disease, and current or past history of cannabis use. Cannabis use is a modifiable risk factor for poor mental health and cardiovascular disease. Using a qualitative focus group approach, we will prospectively explore patterns of cannabis use, tobacco use/other substance use, and their impact on mental health (e.g., depression, anxiety) and physical health (risk factors for cardiovascular disease). Using a quantitative survey, we will quantify the substance use (cannabis and other substance use), physical and mental health, and the prevalence of cardiovascular disease risk factors. The study will be carried out in conjunction with The Bridge Engagement Centre (The Bridge), which has over six years of Community Based Participatory Research (CBPR) experience with marginalized communities, including: people experiencing homeless or at-risk of homelessness, People Who Use Drugs (PWUD), racialized populations, and Indigenous peoples.
Research Objectives:
Objective 1: To understand perceptions, beliefs, cultural practices, and factors that influence cannabis use among marginalized populations with a disproportionate burden of mental illness.
Objective 2: To explore positive and negative experiences of cannabis use in marginalized populations with a disproportionate burden of mental illness.
Objective 3: To understand patterns of cannabis use from adolescence to adulthood and its perceived relationship to mental health in marginalized populations with mental illness.
Objective 4: To understand patterns of cannabis use and its effect on mental health in marginalized populations.
Objective 5: To understand different patterns of cannabis use and its effect on mental health in marginalized populations, specifically looking at youth and adult experiences simultaneously.
Objective 6: To use qualitative methods to encourage storytelling and authentic sharing of individual experiences of mental health and cannabis use among youth populations.
Objective 7: To quantify the prevalence of cardiovascular risk factors among marginalized populations with a cannabis use disorder and poor mental health.
Objective 8: To co-produce knowledge on cardiovascular disease prevention strategies for marginalized populations that use cannabis and report poor mental health.
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 2: 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 a licensed mental health and substance use nurse counselling.
A team of community-based (peer) researchers will enroll 20 youth and 500 adult and youth (16 years and older) participants from Operation Come Home and the Bridge, respectively using iPads for the proposed TCAY-Ottawa study. Participants will be eligible if they: 1) are currently living in Ottawa for at least 3 months prior to enrolment, 2) are homeless or insecurely housed (from Operation Come Home and the Bridge), 3) 16 years or older, 4) have used drugs in the past year, 5) have smoked tobacco in the past 7 days, currently co-use or have a past history of cannabis use, and/or 6) self-report a mental illness. Participation will be entirely voluntary. Community-based researchers will conduct recruitment by working with Operation Come Home and Bridge staff to assess youth and/or adults, who meet the eligibility criteria, and have an interest in participating upon receiving relevant study information (i.e. risks, benefits, remuneration, etc.), which will be provided verbally by the peer researchers or in written form on a study consent document. Upon enrolment, peer researchers will then provide an appointment time for Phase 1 study data collection. All those who are enrolled to participate in the study will be provided with consent forms to assent their own participation.
Peer researchers will administer a one-time questionnaire about their cannabis use and how it relates to their physical and mental health. Some of those participants that co-use tobacco and marijuana and self-report a mental health illness will be invited to participate in a semi-structured interview to collect further data about their smoking and drug use (type of use, frequency of use, etc.), place of access, and facilitators and barriers to use. Participants will receive a $50 cash honorarium as compensation for their participation. Qualitative data will also be collected informally from social support workers and other key informants at Operation Come Home to gain a better understanding of tobacco/drug use patterns among youth, their progress upon joining Operation Come Home, drivers to join the program, and how the issue of addiction(s) affects the youth and their education/job status, mental health, social networks, quality of life, etc.
Understanding specific details from this phase about youth and adult smoking and concurrent illicit drug use will allow peer researchers to develop a more accurate hypothesis and potentially modify qualitative interview questions (from the PROMPT project) that will be asked on a monthly basis during the intervention.
Recruited participants can partake in the two following optional methods:
- Photovoice: 20 recruited participants will be trained on how to use Photovoice.
- Duoethnographic 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1K 4B7
- The Bridge Engagement Centre
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-
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: 300 participants will be invited to participate in a one-time questionnaire. Consequently, up to 25 of those participants will be invited to participate in semi-structured interviews. 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
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Design and deliver an individualized intervention (6 months) to help at-risk youth decrease concurrent poly-substance use.
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6 Months
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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 (Estimated)
Study Completion (Estimated)
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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