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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05626374
Other study ID # R22-013
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date January 15, 2027

Study information

Verified date November 2022
Source Royal Victoria Hospital, Canada
Contact Giulio DiDiodato, MD PhD
Phone 7057289090
Email didiodatog@rvh.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Youth unemployment is a chronic problem in most societies. Some young adults are neither in employment, eduction or training (NEET), and are at high risk of chronic unemployment, social disengagement and poor quality of life. Identifying this high risk population and providing them with career skills training and opportunities is critical for their full participation in society. Vocational training programs provide an opportunity for these NEET youth to develop a skilled trade. Barriers to successful completion of these programs include high prevalence of mental health and substance use disorders among NEET youth. This study will use a daily self-report distress tool to identify vocational program trainees at risk of absence or drop-out due to mental health and/or substance abuse issues. These at-risk trainees will then be referred to a mental health crisis program through a fit-for-purpose referral process to accommodate their training program requirements. It is hypothesized that early identification and referral for mental health and substance abuse issues will reduce both program absence and drop-out rates and result in improved in long-term employment for these NEET youth.


Description:

The Trades & Diversity Training Program (TDTP) is a Canadian federal government-funded vocational construction skills training program for visible minority & female youth who are chronically under- and unemployed. The TDTP is a 12-week program that includes both in-classroom education and supervised hands-on experiential learning at participating construction sites. The trainees are supported by a case manager who identifies, plans and co-ordinates support services to minimize program absences and drop-out. The most significant barriers to successful program completion and long-term employment are mental health and substance use disorders. Historically, identification and rapid referral to mental health and addiction services has been difficult due to human resource limitations and limited access to timely healthcare services. This study will randomize cohorts enrolled in each 12-week training program located in 2 sites to the use of a self-report distress tool versus usual case management. The distress tool is a web-based self-reporting tool that is accessed by trainees on a daily basis to report their distress levels, the underlying reasons for this distress and whether this distress will prevent them from attending class or put them at-risk for drop-out. For those individuals whose distress levels threaten their program participation, the case manager is alerted immediately via an email notification. The case manager is then responsible for connecting with the trainees and engaging the rapid referral process for mental health and addictions healthcare services. The control cohorts will receive the usual case management approach of engaging students on an intermittent basis and providing support as needed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date January 15, 2027
Est. primary completion date January 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - must be a visible minority or female - must be fluent in English or French - must have an active Ontario Health Insurance Plan number - must have a valid Canadian Social Insurance Number - Access to wi-fi network and computing device (phone, tablet, computer) Exclusion Criteria: - none

Study Design


Intervention

Behavioral:
Basic Case Management
Usual case management support during 12-week training program
Basic Case Management plus Distress Tool
Usual case management support during 12-week training program plus daily self-reports of distress using Distress Thermometer tool
Basic Case Management plus rapid mental health & addictions healthcare access
Usual case management support during 12-week training program plus rapid access referral process for healthcare crisis services
Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare access
Usual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services

Locations

Country Name City State
Canada Royal Victoria Regional Health Centre Barrie Ontario

Sponsors (1)

Lead Sponsor Collaborator
Royal Victoria Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Program attendance Difference in proportion of absence-free program days, where absence-free day is defined as being present in class or work setting by case manager or supervisor. Maximum number of absence-free days is 48 days (12 weeks x 4-day work week). A day is defined as an 8- to 10-hour work day from Monday to Thursday. 12 weeks from program enrolment
Primary Program completion Difference in proportion of drop-outs, where a drop-out is defined as an apprentice who fulfils any of the following criteria:
Has missed more than 50% of class/work days, or
Who has elected to leave the program for reasons other than taking another job or returning to school
12 weeks from program enrolment
Primary Post-program employment Difference in proportion of full-time employment, where full-time employment is defined as paid work = 30 (median) hours per week at their main or only job. The reference period that will be used to determine full-time employment is the 4-week period preceding the 24-month post-program completion date. 24 weeks post-program completion
Secondary Access to healthcare services Difference in time to access mental health & addiction services, where time to access is defined as the difference (hours) between the date of referral from the case manager to the date of the mental health & addictions appointment/assessment. 12 weeks from program enrolment
Secondary Healthcare utilization Difference in incidence rates of healthcare days, where healthcare days represent the number of days alive and registered for an emergency room, mental health outpatient or addictions outpatient visit, or admitted to an acute care, mental health or detoxification facility. The potential number of healthcare days is the number of days alive during the program (12 weeks x 7 days = 84 days) 12 weeks from program enrolment
Secondary Apprentice satisfaction Difference in program satisfaction scores, where program satisfaction scores will be measured using the validated National Centre for Vocational Education Research Student Outcomes Survey Satisfaction scores 12 weeks from program enrolment
Secondary Acceptability of self-report distress tool To measure the acceptability of using the Distress Thermometer screening tool by apprentices and the case manager, where acceptability is measured using a validated 2-item questionnaire. 12 weeks from program enrolment
Secondary Feasibility of self-report distress tool To measure the feasibility of using the Distress Thermometer screening tool by apprentices and the case manager, where feasibility is measured using a validated 1-item questionnaire. 12 weeks from program enrolment
Secondary Compliance of self-report distress tool To measure apprentices' compliance with the Distress Thermometer screening tool, where compliance is defined as the ratio of completed daily screens relative to the total number of program days 12 weeks from program enrolment
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