- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626374
Comparing the Effect of Adding a Remote Self-reporting Tool for Distress and Fit-for-purpose Mental Health & Addictions Service to Usual Case Management on Dropout Rates in a Vocational Training Program (TeachMeToBuild)
November 17, 2024 updated by: Giulio DiDiodato, Royal Victoria Hospital, Canada
A Cluster Randomized, 2x2 Factorial, Superiority Study to Compare the Effectiveness of Adding a Remote Self-reporting Tool for Distress and a Fit-for-purpose Mental Health & Addictions Service to Usual Case Management on Program Completion and Employment Among Unemployed Visible Minorities and Women Enrolled in a Vocational Training Program
Youth unemployment is a chronic problem in most societies.
Some young adults are neither in employment, education 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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Barrie, Ontario, Canada, L4M6M2
- Royal Victoria Regional Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Basic case management
Basic case management with bi-weekly meetings between case manager and trainees that includes check-ins, frequent visits to construction sites and monitoring of feedback forms from mentors.
Case managers attempt to connect trainees with external support services as needed.
|
Usual case management support during 12-week training program
|
|
Experimental: Basic case management supplemented by self-reporting distress tool (DT)
Basic case management plus access to the self-report daily distress tool.
The trainees are provided web-based access to the daily distress tool and report their distress levels using a validated visual analog scale (Distress Thermometer), along with reporting their risk of missing work/class or dropping out of the program.
The case manager responds to the distress tool by coordinating external support services as needed.
|
Usual case management support during 12-week training program plus daily self-reports of distress using Distress Thermometer tool
|
|
Experimental: Basic case management supplemented by rapid access healthcare services
Basic case management supplemented by a fit-for-purpose rapid referral process for trainees with active mental health and/or substance use disorders affecting their program participation.
|
Usual case management support during 12-week training program plus rapid access referral process for healthcare crisis services
|
|
Experimental: Basic case management supplemented by DT and rapid access healthcare services
Basic case management supplemented by both the self-report distress tool and rapid referral process for those trainees at-risk of program absence or drop-out from either mental health or addictions issues.
|
Usual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program attendance
Time Frame: 12 weeks from program enrolment
|
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
|
|
Program completion
Time Frame: 12 weeks from program enrolment
|
Difference in proportion of drop-outs, where a drop-out is defined as an apprentice who fulfils any of the following criteria:
|
12 weeks from program enrolment
|
|
Post-program employment
Time Frame: 24 weeks post-program completion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Access to healthcare services
Time Frame: 12 weeks from program enrolment
|
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
|
|
Healthcare utilization
Time Frame: 12 weeks from program enrolment
|
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
|
|
Apprentice satisfaction
Time Frame: 12 weeks from program enrolment
|
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
|
|
Acceptability of self-report distress tool
Time Frame: 12 weeks from program enrolment
|
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
|
|
Feasibility of self-report distress tool
Time Frame: 12 weeks from program enrolment
|
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
|
|
Compliance of self-report distress tool
Time Frame: 12 weeks from program enrolment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giulio DiDiodato, MD PhD, Royal Victoria Regional Health Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2023
Primary Completion (Estimated)
January 15, 2026
Study Completion (Estimated)
January 15, 2027
Study Registration Dates
First Submitted
November 15, 2022
First Submitted That Met QC Criteria
November 15, 2022
First Posted (Actual)
November 23, 2022
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 17, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R22-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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