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

About this trial
This is an interventional treatment trial for Mental Disorder
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
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
NCT ID
NCT03118388
First Posted
April 6, 2017
Last Updated
April 13, 2017
Sponsor
Arizona State University
Collaborators
University of Southern California
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
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Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
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