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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)

Primary Purpose

Mental Health Issue, Substance Use Disorders, Distress, Emotional

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Basic Case Management
Basic Case Management plus Distress Tool
Basic Case Management plus rapid mental health & addictions healthcare access
Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare access
Sponsored by
Royal Victoria Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Issue focused on measuring mental health issues, substance use disorders, multi-centre trial, cluster randomized, factorial design, vocational training program, vulnerable youth, unemployment

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Victoria Regional Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Basic case management

Basic case management supplemented by self-reporting distress tool (DT)

Basic case management supplemented by rapid access healthcare services

Basic case management supplemented by DT and rapid access healthcare services

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.
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)
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
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.
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.
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

Full Information

First Posted
November 15, 2022
Last Updated
November 15, 2022
Sponsor
Royal Victoria Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05626374
Brief Title
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
Acronym
TeachMeToBuild
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Victoria Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Substance Use Disorders, Distress, Emotional
Keywords
mental health issues, substance use disorders, multi-centre trial, cluster randomized, factorial design, vocational training program, vulnerable youth, unemployment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial design, cluster-randomized, multicentre trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Basic case management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Basic case management supplemented by self-reporting distress tool (DT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Basic case management supplemented by rapid access healthcare services
Arm Type
Experimental
Arm Description
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.
Arm Title
Basic case management supplemented by DT and rapid access healthcare services
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Basic Case Management
Intervention Description
Usual case management support during 12-week training program
Intervention Type
Behavioral
Intervention Name(s)
Basic Case Management plus Distress Tool
Intervention Description
Usual case management support during 12-week training program plus daily self-reports of distress using Distress Thermometer tool
Intervention Type
Behavioral
Intervention Name(s)
Basic Case Management plus rapid mental health & addictions healthcare access
Intervention Description
Usual case management support during 12-week training program plus rapid access referral process for healthcare crisis services
Intervention Type
Behavioral
Intervention Name(s)
Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare access
Intervention Description
Usual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services
Primary Outcome Measure Information:
Title
Program attendance
Description
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.
Time Frame
12 weeks from program enrolment
Title
Program completion
Description
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
Time Frame
12 weeks from program enrolment
Title
Post-program employment
Description
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.
Time Frame
24 weeks post-program completion
Secondary Outcome Measure Information:
Title
Access to healthcare services
Description
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.
Time Frame
12 weeks from program enrolment
Title
Healthcare utilization
Description
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)
Time Frame
12 weeks from program enrolment
Title
Apprentice satisfaction
Description
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
Time Frame
12 weeks from program enrolment
Title
Acceptability of self-report distress tool
Description
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.
Time Frame
12 weeks from program enrolment
Title
Feasibility of self-report distress tool
Description
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.
Time Frame
12 weeks from program enrolment
Title
Compliance of self-report distress tool
Description
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
Time Frame
12 weeks from program enrolment

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio DiDiodato, MD PhD
Phone
7057289090
Ext
45641
Email
didiodatog@rvh.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Cruise, BHSc
Phone
705-728-9090
Ext
45639
Email
cruisek@rvh.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio DiDiodato, MD PhD
Organizational Affiliation
Royal Victoria Regional Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M6M2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Cruise, BHSc
Phone
7057289090
Ext
45639
Email
cruisek@rvh.on.ca
First Name & Middle Initial & Last Name & Degree
Shawna Bailey, BA
First Name & Middle Initial & Last Name & Degree
Carrie Stoner, BA

12. IPD Sharing Statement

Learn more about this trial

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

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