NCT05626374

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Jan 2027

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Expected
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 15, 2022

Last Update Submit

November 17, 2024

Conditions

Keywords

mental health issuessubstance use disordersmulti-centre trialcluster randomizedfactorial designvocational training programvulnerable youthunemployment

Outcome Measures

Primary Outcomes (3)

  • 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

  • Program completion

    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

    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 Outcomes (6)

  • Access to healthcare services

    12 weeks from program enrolment

  • Healthcare utilization

    12 weeks from program enrolment

  • Apprentice satisfaction

    12 weeks from program enrolment

  • Acceptability of self-report distress tool

    12 weeks from program enrolment

  • Feasibility of self-report distress tool

    12 weeks from program enrolment

  • +1 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Behavioral: Basic Case Management plus Distress Tool and rapid mental health & addictions healthcare access

Interventions

Usual case management support during 12-week training program

Basic case management

Usual case management support during 12-week training program plus daily self-reports of distress using Distress Thermometer tool

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

Usual case management support during 12-week training program plus rapid access referral process for healthcare crisis services

Basic case management supplemented by rapid access healthcare services

Usual case management support during 12-week training program plus daily distress self-reports plus rapid access referral process for healthcare crisis services

Basic case management supplemented by DT and rapid access healthcare services

Eligibility Criteria

Age18 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale based on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Giulio DiDiodato, MD PhD

    Royal Victoria Regional Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 2x2 factorial design, cluster-randomized, multicentre trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Research Scientist

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

January 15, 2023

Primary Completion

January 15, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations