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IPS/Peer Support Intervention in the DTES

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ClinicalTrials.gov Identifier: NCT03748004
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Ministry of Social Development and Poverty Reduction, British Columbia
Information provided by (Responsible Party):
Skye Barbic, University of British Columbia

Brief Summary:
Individual placement support (IPS) is an evidence-based supported employment model for people with severe mental illness, designed to achieve employment in mainstream competitive jobs, either part-time or full-time. The aim of this study is to assess the (i) effectiveness of embedding the (IPS)/Peer Support intervention as part of the primary care centre in securing employment of adults living in the downtown eastside in comparison to the usual treatment WorkBC (control group). (ii) effectiveness of IPS/Peer Support versus the usual treatment (WorkBC) in improving mental illness, quality of life and personal recovery through participation in employment.

Condition or disease Intervention/treatment Phase
Behavior, Adaptive Mental Illness Substance Use Behavioral: IPS/SP Behavioral: WorkBC Not Applicable

Detailed Description:
This 18-month mixed methods study consists of an effectiveness multi-site randomized controlled trial of the IPS/peer support intervention plus an embedded qualitative exploration of participants' experiences. All clients receiving primary care services from one DTES clinical site who are employment ready and are not receiving mental health services will be randomly assigned to IPS & Peer Support (experimental group) or WorkBC (control group). Clients are required to participate in the intervention for 16 weeks and will be assessed at baseline, 1-, 3-, and 6-months post study intervention start-date for both groups. Assessments will include the 5 questionnaires administered at baseline which cover the following: Employment Quality, Employment Sustainability, Education Quality and Quantity, Quality of Life, Community Engagement and Clinical significant levels of depression and anxiety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 72 clients receiving primary care services from one DTES clinical site who are employment ready will be randomly assigned to IPS and Peer Support (experimental group) or WorkBC (control group).
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Optimizing the Employment Outcomes for People Living in the Downtown Eastside
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Adults living in the DTES

36 out of the 72 recruited participants who live in the DTES will be randomly assigned to the intervention group (IPS & Peer Support). The IPS and Peer Support will actively work and support with each of the 36 participants in seeking employment and education for 16 weeks. IPS/SP will help participants identify their employment and educational goals, identify potential employers, help prepare their resumes and for interviews, and provide ongoing support during the 16 weeks.

36 out of the 72 participants who live in the DTES will be randomly assigned to the control group (WorkBC). Participants will be provided with WorkBC employment services.

Behavioral: IPS/SP
The 72 recruited clients receiving primary care services from one DTES clinical site who are employment ready will be randomly assigned to IPS and Peer Support (experimental group) or WorkBC control group

Placebo Comparator: Individuals 19 yrs or older settled in DTES

36 out of the 72 recruited participants who live in the DTES will be randomly assigned to the intervention group (IPS & Peer Support). The IPS and Peer Support will actively work and support with each of the 36 participants in seeking employment and education for 16 weeks. IPS/SP will help participants identify their employment and educational goals, identify potential employers, help prepare their resumes and for interviews, and provide ongoing support during the 16 weeks.

36 out of the 72 participants who live in the DTES will be randomly assigned to the control group (WorkBC). Participants will be provided with WorkBC employment services.

Behavioral: WorkBC
36 out of the 72 participants who live in the DTES will be randomly assigned to the control group (WorkBC). Participants will be provided with WorkBC employment services.




Primary Outcome Measures :
  1. Securing employment [ Time Frame: 18 months ]
    RC will follow-up with all recruited clients who get employed through the IPS/Peer Support intervention and the WorkBC control group.


Secondary Outcome Measures :
  1. "PHQ-9" Questionnaire to measures level of depression [ Time Frame: 18 months ]
    Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. The minimum score is 0/27 and the maximum score is 27

  2. "GAD7" questionnaire to measure general anxiety disorder [ Time Frame: 18 months ]
    Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. The minimum score is 0/21. The maximum score is 21.

  3. "C-PROM" questionnaire to measure Personal Recovery [ Time Frame: 18 months ]
    Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 0/120. Maximum score is 120

  4. "REQOL" questionnaire measures Recovery Quality of Life [ Time Frame: 18 months ]
    Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 0/64. Maximum score 64.

  5. "SWL" questionnaire measures satisfaction with life [ Time Frame: 18 months ]
    Participants will answer the questions on this questionnaire using a likert scale. A scoring system will calculate the final total number and we will assess mean change from the baseline. Minimum score is 5/35. Maximum score is 35.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults, age 19 and over, accessing primary care services at the primary care centre listed in this study (CH Pender Community Health Centre)
  • At least one visit to VCH Pender Community Health Centre
  • Currently unemployed and not in school or post-secondary training.
  • Able to provide informed consent and fluent in English (intervention is currently offered in English only).
  • Not hospitalized at the time of recruitment.

Exclusion Criteria:

• Adults, age 19 and over who have access to mental health services


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748004


Contacts
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Contact: Skye Barbic, PhD 778 846 6134 skye.barbic@ubc.ca

Locations
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Canada, British Columbia
Downtown Community Health Center Recruiting
Vancouver, British Columbia, Canada, V6A 1G9
Contact: Smadar Levinson         
Heatley Community Health Clinic Recruiting
Vancouver, British Columbia, Canada, V6A 3G3
Contact: Smadar Levinson    6046199150      
Pender Community Health Clinic Recruiting
Vancouver, British Columbia, Canada, V6B 1R3
Contact: Smadar Levinson    6046199150      
Sponsors and Collaborators
University of British Columbia
Ministry of Social Development and Poverty Reduction, British Columbia
Investigators
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Principal Investigator: Skye Barbic, PhD University of British Columbia
Publications:
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Responsible Party: Skye Barbic, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03748004    
Other Study ID Numbers: H18-02740
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is a pilot study (early phase)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Skye Barbic, University of British Columbia:
Homeless
Employment
Additional relevant MeSH terms:
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Mental Disorders