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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04812613
Other study ID # 20180595-01H
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 1, 2023

Study information

Verified date March 2023
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 173
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada The Bridge Engagement Centre Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Operation Come Home

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Explore the frequency of tobacco and other drug use 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
Primary Tobacco and other drug use reduction Design and deliver an individualized intervention (6 months) to help at-risk youth decrease concurrent poly-substance use. 6 Months
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