Mental Health IssueTeachMeToBuildNCT05626374
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
A study testing Basic Case Management, Basic Case Management plus Distress Tool and Basic Case Management plus rapid mental health & addictions healthcare access in people with Mental Health Issue and Substance Use Disorders, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Mental Health Issue, Substance Use Disorders, Distress, Emotional
- What is being tested?
- Basic Case Management, Basic Case Management plus Distress Tool and Basic Case Management plus rapid mental health & addictions healthcare access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2023to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- 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
- Keywords
- mental health issues, substance use disorders, multi-centre trial, cluster randomized, factorial design, vocational training program, vulnerable youth, unemployment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Case ManagementBehavioural
Usual case management support during 12-week training program
Basic Case Management plus Distress ToolBehavioural
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 accessBehavioural
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 accessBehavioural
Usual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services
| Study group | Role | What they receive |
|---|---|---|
| Basic case management | Active comparator | 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. Receives: Behavioral: Basic Case Management |
| Basic case management supplemented by self-reporting distress tool (DT) | Experimental | 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. Receives: Behavioral: Basic Case Management plus Distress Tool |
| Basic case management supplemented by rapid access healthcare services | Experimental | 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. Receives: Behavioral: Basic Case Management plus rapid mental health & addictions healthcare access |
| Basic case management supplemented by DT and rapid access healthcare services | Experimental | 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. Receives: Behavioral: Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from program enrolment
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
Measured: 12 weeks from program enrolment
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.
Measured: 24 weeks post-program completion
Secondary outcomes (6)
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.
Measured: 12 weeks from program enrolment
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)
Measured: 12 weeks from program enrolment
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
Measured: 12 weeks from program enrolment
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.
Measured: 12 weeks from program enrolment
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.
Measured: 12 weeks from program enrolment
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
Measured: 12 weeks from program enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start15 Jan 2023
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design, cluster-randomized, multicentre trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio DiDiodato, Royal Victoria Hospital, Canada
- Investigators
- Giulio DiDiodato, MD PhD, Principal investigator, Royal Victoria Regional Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626374
- Sponsor's protocol ID
- R22-013
- Acronym
- TeachMeToBuild
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bailey S, Stoner C, Cruise K, DiDiodato G. Protocol for a cluster randomized study to compare the effectiveness of a self-report distress tool and a mental health referral service to usual case management on program completion among vulnerable youth enrolled in a vocational training program. PLoS One. 2024 Aug 1;19(8):e0294806. doi: 10.1371/journal.pone.0294806. eCollection 2024.
PubMed 39088460
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05626374
- Acronym / sponsor ID
- TeachMeToBuild / R22-013
- Keywords
- mental health issues, substance use disorders, multi-centre trial, cluster randomized, factorial design, vocational training program, vulnerable youth, unemployment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial design, cluster-randomized, multicentre trial
| Arm | Type | Receives |
|---|---|---|
| Basic case management | Active comparator | Behavioral: Basic Case ManagementBasic 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 supplemented by self-reporting distress tool (DT) | Experimental | Behavioral: Basic Case Management plus Distress ToolBasic 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 rapid access healthcare services | Experimental | Behavioral: Basic Case Management plus rapid mental health & addictions healthcare accessBasic 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 DT and rapid access healthcare services | Experimental | Behavioral: Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare accessBasic 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Case ManagementUsual case management support during 12-week training program | Behavioural | Basic case management |
| Basic Case Management plus Distress ToolUsual case management support during 12-week training program plus daily self-reports of distress using Distress Thermometer tool | Behavioural | Basic case management supplemented by self-reporting distress tool (DT) |
| Basic Case Management plus rapid mental health & addictions healthcare accessUsual case management support during 12-week training program plus rapid access referral process for healthcare crisis services | Behavioural | Basic case management supplemented by rapid access healthcare services |
| Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare accessUsual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services | Behavioural | Basic case management supplemented by DT and rapid access healthcare services |
Primary outcome
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.
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: 1. Has missed more than 50% of class/work days, or 2. Who has elected to leave the program for reasons other than taking another job or returning to school
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.
6 secondary outcomes
Access to healthcare services
Time frame: 12 weeks from program enrolment
Healthcare utilization
Time frame: 12 weeks from program enrolment
Apprentice satisfaction
Time frame: 12 weeks from program enrolment
Acceptability of self-report distress tool
Time frame: 12 weeks from program enrolment
Feasibility of self-report distress tool
Time frame: 12 weeks from program enrolment
Compliance of self-report distress tool
Time frame: 12 weeks from program enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 39088460Bailey S, Stoner C, Cruise K, DiDiodato G. Protocol for a cluster randomized study to compare the effectiveness of a self-report distress tool and a mental health referral service to usual case management on program completion among vulnerable youth enrolled in a vocational training program. PLoS One. 2024 Aug 1;19(8):e0294806. doi: 10.1371/journal.pone.0294806. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulio DiDiodato, MD PhD principal investigator
Royal Victoria Regional Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Case Management, Basic Case Management plus Distress Tool and Basic Case Management plus rapid mental health & addictions healthcare access in people with Mental Health Issue and Substance Use Disorders, run by Royal Victoria Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program attendance (time frame: 12 weeks from program enrolment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.