Clinical trial NCT04812613: Tobacco-Concurrent Addictions in At-Risk Youth in Ottawa
Official title: Tobacco Concurrent Addictions in At-Risk Youth in Ottawa: A Mixed Methods Community-Based Participatory Action Research Project (TCAY- Ottawa)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tobacco Use
Substance Use
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Operation Come Home
First posted: 2021-03-23
Enrollment: 173
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 youth and 200 adult participants

Brief summary: According to the 2015 Ontario Student Drug Use and Health Survey (OSDUHS), there has been a significant increase in the number of secondary school youth who use poly-substances. Not all youth have the same risk for problematic substance use. Health literature documents a high level of comorbidity between mental health and substance use, which is exacerbated in homeless youth populations. Therefore, the proposed study will focus on understanding poly-substance use among at-risk homeless school youth. As seen in substance use research and the PROMPT (2016) study (Participatory Research in Ottawa: Management and Point-of-Care for Tobacco Dependence, PI: Dr. Smita Pakhale), reduction and quitting of one substance (tobacco smoking) can lead to the reduction and quitting of other poly-substance use. A Community-Based Participatory Action Research (CBPAR) approach can help at-risk youth feel safe and comfortable enough to provide personal information about their poly-substance use and engagement with treatment or harm reduction programs. This project will be a first step in increasing health equity among at-risk homeless youth in Downtown Ottawa. The investigators aim to follow a group of at-risk youth to while providing an appropriately modified PROMPT intervention, including peers support and a licensed mental health and substance use nurse.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Explore the frequency of tobacco and other drug use
timeFrame: 6 Months
measure: Tobacco and other drug use reduction
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Bridge Engagement Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital
name: Smita Pakhale, M.D.
role: PRINCIPAL_INVESTIGATOR
References: