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Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs (SEI)

Primary Purpose

Mental Disorder, Mental Health, Employment

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Social Enterprise Intervention
IPS
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 16-24
  • English speaking
  • Primary clinical diagnosis in the past year (with at least one symptom in the past 4 weeks) using the DISC-Y interview for one of six mental illnesses (i.e., Major Depressive Episode, Mania/ Hypomania, Generalized Anxiety, Post-traumatic Stress Disorder, Conduct Disorder, and Alcohol/Substance Use Disorders
  • Desire to work.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    36 SEI youth

    36 IPS youth

    Arm Description

    36 homeless youth (ages 16-24) randomized to the SEI intervention

    36 homeless youth (ages 16-24) randomized to the IPS intervention

    Outcomes

    Primary Outcome Measures

    Change in depression between baseline and follow-up (using the Adult Self-Report)
    Depression was assessed using the Adult Self-Report (ASR) DSM-Oriented Scale for Depressive Problems, consisting of 14 items that measure related emotions and behaviors (Achenbach, 1997). Scoring profiles used normed scales for adults ages 18-35. Higher scores reflected a higher presence of emotions and behaviors. For men, raw scores between 10 and 12 (11 and 13 for women) were within the borderline clinical range, whereas scores 13 and greater (14 and greater for women) were considered in the clinical range.
    Change in social support between baseline and follow-up (using the Adult Self-Report)
    Social support was a composite-score variable of the sum of four items on the ASR Friends Subscale. The response categories for each item range from none to 5 or more for questions including: "About how many close friends do you have?" The range of scores is from 0 to 12, with higher scores indicating greater social support for the youth.
    Change in housing stability status between baseline and follow-up (using a 3-item self-report measure of housing status)
    Youth were asked at 20 months about their housing status (i.e., whether they had lived on the streets, in a shelter or institution [i.e., youth or adult shelter, or detention facility, jail, or prison], or in a private residence with family [i.e., biological or foster], relatives, friends, a partner, roommate or alone). Each item was dichotomous and scored as 0 = no or 1 = yes.
    Change in self-esteem between baseline and follow-up (using the Rosenberg Self-Esteem Scale)
    Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSE; Rosenberg, 1979), a 10-question assessment of feelings about self-worth. Each item is rated using a 4-point Likert-type scale ranging from strongly disagree to strongly agree. Five items are recoded so that higher scores indicate higher levels of self-esteem. The possible range of RSE raw scores is 0 to 30. Scores between 15 and 25 are within normal range, whereas scores below 15 suggest low self-esteem.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2017
    Last Updated
    April 13, 2017
    Sponsor
    Arizona State University
    Collaborators
    University of Southern California
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03118388
    Brief Title
    Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
    Acronym
    SEI
    Official Title
    Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 18, 2009 (Actual)
    Primary Completion Date
    August 31, 2011 (Actual)
    Study Completion Date
    August 31, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University
    Collaborators
    University of Southern California

    4. Oversight

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

    5. Study Description

    Brief Summary
    This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness. Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.
    Detailed Description
    In response to the limited use of RCTs with homeless youth to test research-supported interventions, this study compares the efficacy and short-term outcomes of two interventions that combine employment and clinical services with homeless youth experiencing mental illness. The Social Enterprise Intervention (SEI) is a research-supported intervention using a group approach that engages homeless youth in paid employment as well as case-management and mental health services through involvement in an agency-run social enterprise. The Individual Placement and Support (IPS) model of supported employment is an individually focused, evidence-based intervention , which provides individuals with severe mental illness with customized, long-term, and integrated vocational, case-management, and clinical services to help them gain and maintain competitive employment. A randomized comparative efficacy trial of the short-term, nonvocational outcomes (depression, self-esteem, social support, housing stability) of the SEI and IPS was conducted over 20 months with 72 homeless youth at a homeless youth drop-in center in Los Angeles. This study answered two research questions: 1) Do homeless youth with mental illness participating in an employment intervention integrated with clinical services (SEI or IPS) experience improvements in their a) mental health status (self-esteem and depression); b) housing stability, and c) social support; and 2) What are the differences between the SEI and IPS groups on mental health, housing stability, and social support outcomes between baseline and follow-up?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder, Mental Health, Employment, Housing Problems, Social Support

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months). The eight IPS principles were implemented over 20 months by an employment specialist, clinician, and case manager.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    36 SEI youth
    Arm Type
    Experimental
    Arm Description
    36 homeless youth (ages 16-24) randomized to the SEI intervention
    Arm Title
    36 IPS youth
    Arm Type
    Experimental
    Arm Description
    36 homeless youth (ages 16-24) randomized to the IPS intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Social Enterprise Intervention
    Other Intervention Name(s)
    SEI, social enterprise
    Intervention Description
    The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months).
    Intervention Type
    Behavioral
    Intervention Name(s)
    IPS
    Other Intervention Name(s)
    Individual Placement and Support, supported employment
    Intervention Description
    To implement the IPS at the host agency, one employment specialist, two case managers, and two clinicians were assigned the 22 available IPS cases among them at baseline. Over the 20 months, all IPS participants met individually with the employment specialist, one case manager, and one clinician at least weekly. Regarding job development in the community, the IPS employment specialist also spent about 40% of each week out in the community building relationships with new and existing employers.
    Primary Outcome Measure Information:
    Title
    Change in depression between baseline and follow-up (using the Adult Self-Report)
    Description
    Depression was assessed using the Adult Self-Report (ASR) DSM-Oriented Scale for Depressive Problems, consisting of 14 items that measure related emotions and behaviors (Achenbach, 1997). Scoring profiles used normed scales for adults ages 18-35. Higher scores reflected a higher presence of emotions and behaviors. For men, raw scores between 10 and 12 (11 and 13 for women) were within the borderline clinical range, whereas scores 13 and greater (14 and greater for women) were considered in the clinical range.
    Time Frame
    20 months
    Title
    Change in social support between baseline and follow-up (using the Adult Self-Report)
    Description
    Social support was a composite-score variable of the sum of four items on the ASR Friends Subscale. The response categories for each item range from none to 5 or more for questions including: "About how many close friends do you have?" The range of scores is from 0 to 12, with higher scores indicating greater social support for the youth.
    Time Frame
    20 months
    Title
    Change in housing stability status between baseline and follow-up (using a 3-item self-report measure of housing status)
    Description
    Youth were asked at 20 months about their housing status (i.e., whether they had lived on the streets, in a shelter or institution [i.e., youth or adult shelter, or detention facility, jail, or prison], or in a private residence with family [i.e., biological or foster], relatives, friends, a partner, roommate or alone). Each item was dichotomous and scored as 0 = no or 1 = yes.
    Time Frame
    20 months
    Title
    Change in self-esteem between baseline and follow-up (using the Rosenberg Self-Esteem Scale)
    Description
    Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSE; Rosenberg, 1979), a 10-question assessment of feelings about self-worth. Each item is rated using a 4-point Likert-type scale ranging from strongly disagree to strongly agree. Five items are recoded so that higher scores indicate higher levels of self-esteem. The possible range of RSE raw scores is 0 to 30. Scores between 15 and 25 are within normal range, whereas scores below 15 suggest low self-esteem.
    Time Frame
    20 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 16-24 English speaking Primary clinical diagnosis in the past year (with at least one symptom in the past 4 weeks) using the DISC-Y interview for one of six mental illnesses (i.e., Major Depressive Episode, Mania/ Hypomania, Generalized Anxiety, Post-traumatic Stress Disorder, Conduct Disorder, and Alcohol/Substance Use Disorders Desire to work. Exclusion Criteria: None

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs

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