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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Basic Case Management
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.
Behavioral: 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
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.
Behavioral: 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
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.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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:

  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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Victoria Hospital, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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